A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

Sponsor

UCB Biopharma S.P.R.L. (Industry)

Overall Status

Completed

CT.gov ID

NCT02804763

Collaborator

(none)

182

Enrollment

Locations

Arms

29.6

Actual Duration (Months)

2.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus (SLE)	Drug: Placebo Drug: Dapirolizumab pegol (DZP)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

182 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

Actual Study Start Date :

Jun 2, 2016

Actual Primary Completion Date :

May 31, 2018

Actual Study Completion Date :

Nov 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo in a specified sequence for a total of 24 weeks	Drug: Placebo Solution for infusion, 0,9% saline
Experimental: DZP dose 1 Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks	Drug: Dapirolizumab pegol (DZP) Solution for infusion
Experimental: DZP dose 2 Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks	Drug: Dapirolizumab pegol (DZP) Solution for infusion
Experimental: DZP dose 3 Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks	Drug: Dapirolizumab pegol (DZP) Solution for infusion

Outcome Measures

Primary Outcome Measures

Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24 [Week 24]
The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.

Secondary Outcome Measures

The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24 [Week 24]
BICLA response was defined as meeting all of the following criteria: BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Percentage of Participants With at Least One Adverse Events (AEs) [From Baseline (Week 1) until end of the study (Week 48)]
An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Percentage of Participants With a Serious Adverse Event (SAE) [From Baseline (Week 1) until end of the study (Week 48)]
A Serious Adverse Event (SAE) must have met 1 or more of the following criteria: Death Life threatening Significant or persistent disability/incapacity Congenital anomaly/birth defect (including that occurring in a fetus) Important medical event that, based upon appropriate medical judgment, may have jeopardized the study participant, and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious Initial inpatient hospitalization or prolongation of hospitalization.
Percentage of Participants With at Least One Adverse Events (AEs) of Interest [From Baseline (Week 1) until end of the study (Week 48)]
Adverse events of interest (AEOI) were identified by the Investigator based on definitions per protocol, documented on the electronic Case Report Form (eCRF), adequately monitored, and source controlled. AEOI (regardless of seriousness): Moderate to severe infections, including opportunistic infections and tuberculosis (TB) Infusion reactions (including hypersensitivity and anaphylaxis) Thromboembolic events (including but not limited to cardiovascular events, stroke, myocardial infarction, pulmonary embolism, and deep vein thrombosis) Prespecified neurological events: severe and/or serious headache, positional headache, cranial nerve dysfunction, or signs and symptoms of meningitis (photophobia, neck stiffness) Malignancies.
Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE) [From Baseline (Week 1) until end of the study (Week 48)]
An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Mean Change From Baseline in Systolic Blood Pressure [From Baseline (Week 1) to Week 48]
Blood pressure was measured in millimetre of mercury (mmHg).
Mean Change From Baseline in Diastolic Blood Pressure [From Baseline (Week 1) to Week 48]
Blood pressure was measured in millimetre of mercury (mmHg).
Mean Change From Baseline in Pulse Rate [From Baseline (Week 1) to Week 48]
Pulse Rate was measured in beats per minute (beats/min).
Mean Change From Baseline in Temperature [From Baseline (Week 1) to Week 48]
Temperature was measured in Grad Celsius (°C).
Mean Change From Baseline in Weight [Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20]
Weight was measured in kilograms (kg).
Mean Change From Baseline in Height [From Baseline (Week 1) to Week 48]
Height was measured in centimeters (cm).
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings [Screening, Week 4, Week 24, Week 28 and Week 48]
Twelve-lead ECG assessments should have been performed prior to dosing (if applicable) and prior to obtaining pharmacokinetic (PK) or other laboratory samples. Electrocardiograms were recorded digitally and read by the Investigator for recording in the electronic Case Report Form (eCRF).
Mean Change From Baseline in Hemoglobin [From Baseline (Week 1) to Week 48]
Hemoglobin was measured in grams per liter (g/L).
Mean Change From Baseline in Hematocrit [From Baseline (Week 1) to Week 48]
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Mean Change From Baseline in Erythrocytes [From Baseline (Week 1) to Week 48]
Erythrocytes was measured in number of erythrocytes per liter (10^12/L).
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume [From Baseline (Week 1) to Week 48]
Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration [From Baseline (Week 1) to Week 48]
Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L).
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin [From Baseline (Week 1) to Week 48]
Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg).
Mean Change From Baseline in Leukocytes [From Baseline (Week 1) to Week 48]
Leukocytes was measured in number of leukocytes per liter (10^9/L).
Mean Change From Baseline in Basophils [From Baseline (Week 1) to Week 48]
Basophils was measured in number of basophils per liter (10^9/L).
Mean Change From Baseline in Basophils/Leukocytes [From Baseline (Week 1) to Week 48]
Basophils/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Eosinophils [From Baseline (Week 1) to Week 48]
Eosinophils was measured in number of eosinophils per liter (10^9/L).
Mean Change From Baseline in Eosinophils/Leukocytes [From Baseline (Week 1) to Week 48]
Eosinophils/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Lymphocytes [From Baseline (Week 1) to Week 48]
Lymphocytes was measured in number of lymphocytes per liter (10^9/L).
Mean Change From Baseline in Lymphocytes/Leukocytes [From Baseline (Week 1) to Week 48]
Lymphocytes/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Monocytes [From Baseline (Week 1) to Week 48]
Monocytes was measured in number of monocytes per liter (10^9/L).
Mean Change From Baseline in Monocytes/Leukocytes [From Baseline (Week 1) to Week 48]
Monocytes/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Neutrophils [From Baseline (Week 1) to Week 48]
Neutrophils was measured in number of neutrophils per liter (10^9/L).
Mean Change From Baseline in Neutrophils/Leukocytes [From Baseline (Week 1) to Week 48]
Neutrophils/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Platelets [From Baseline (Week 1) to Week 48]
Platelets was measured in number of platelets per liter (10^9/L).
Mean Change From Baseline in Cluster of Differentiation 3 (CD3) [From Baseline (Week 1) to Week 48]
Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL).
Mean Change From Baseline in CD3/Lymphocytes [From Baseline (Week 1) to Week 48]
CD3/Lymphocytes was measured in percentages (%).
Mean Change From Baseline in Cluster of Differentiation 19 (CD19) [From Baseline (Week 1) to Week 48]
Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL).
Mean Change From Baseline in CD19/Lymphocytes [From Baseline (Week 1) to Week 48]
CD19/Lymphocytes was measured in percentages (%).
Mean Change From Baseline in Aspartate Aminotransferase [From Baseline (Week 1) to Week 48]
Aspartate Aminotransferase was measured in units per liter (U/L).
Mean Change From Baseline in Alanine Aminotransferase [From Baseline (Week 1) to Week 48]
Alanine Aminotransferase was measured in units per liter (U/L).
Mean Change From Baseline in Alkaline Phosphatase [From Baseline (Week 1) to Week 48]
Alkaline Phosphatase was measured in units per liter (U/L).
Mean Change From Baseline in Gamma Glutamyl Transferase [From Baseline (Week 1) to Week 48]
Gamma Glutamyl Transferase was measured in units per liter (U/L).
Mean Change From Baseline in Bilirubin [From Baseline (Week 1) to Week 48]
Bilirubin was measured in micromols per liter (µmol/L).
Mean Change From Baseline in Direct Bilirubin [From Baseline (Week 1) to Week 48]
Direct Bilirubin was measured in micromols per liter (µmol/L).
Mean Change From Baseline in Lactate Dehydrogenase [From Baseline (Week 1) to Week 48]
Lactate Dehydrogenase was measured in units per liter (U/L).
Mean Change From Baseline in Creatinine [From Baseline (Week 1) to Week 48]
Creatinine was measured in micromols per liter (µmol/L).
Mean Change From Baseline in Urea Nitrogen [From Baseline (Week 1) to Week 48]
Urea Nitrogen was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Sodium [From Baseline (Week 1) to Week 48]
Sodium was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Potassium [From Baseline (Week 1) to Week 48]
Potassium was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Calcium [From Baseline (Week 1) to Week 48]
Calcium was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Phosphate [From Baseline (Week 1) to Week 48]
Phosphate was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Cholesterol [From Baseline (Week 1) to Week 48]
Cholesterol was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Triglycerides [From Baseline (Week 1) to Week 48]
Triglycerides was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Protein [From Baseline (Week 1) to Week 48]
Protein was measured in grams per liter (g/L).
Mean Change From Baseline in Albumin [From Baseline (Week 1) to Week 48]
Albumin was measured in grams per liter (g/L).
Mean Change From Baseline in Glucose [From Baseline (Week 1) to Week 48]
Glucose was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Lipase, Pancreatic [From Baseline (Week 1) to Week 48]
Lipase, Pancreatic was measured in units per liter (U/L).
Mean Change From Baseline in Creatine Kinase [From Baseline (Week 1) to Week 48]
Creatine Kinase was measured in units per liter (U/L).
Mean Change From Baseline in pH [From Baseline (Week 1) to Week 48]
Mean Change From Baseline in Erythrocytes (/HPF) [From Baseline (Week 1) to Week 48]
Mean Change From Baseline in Leukocytes (/HPF) [From Baseline (Week 1) to Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
Moderate to severe SLE disease activity
Evidence for at least 1 of the following SLE markers:
Anti-dsDNA antibodies confirmed by central laboratory or
Low complement confirmed by central laboratory or
Antinuclear antibody (ANA) titer of >= 1:80 in combination with at least 1 of the following: Historical positivity for anti-dsDNA or Positivity for extractable nuclear antigen (anti-ENA) confirmed by central laboratory
The subject is receiving stable SLE standard-of-care medication

Exclusion Criteria:

Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE
Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments.
New or worsening Class III or IV lupus nephritis
Chronic kidney failure stage 3b
Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
Clinically significant active or latent infection (eg. chronic viral hepatitis B or C)
Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection
Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug
History of thromboembolic events within 12 months of screening
Subject has used protocol defined prohibited medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sl0023 312	Birmingham	Alabama	United States	35294
2	Sl0023 307	El Cajon	California	United States	92020
3	Sl0023 309	El Cajon	California	United States	92020
4	Sl0023 323	Huntington Beach	California	United States	92646
5	Sl0023 311	Los Angeles	California	United States	90048
6	Sl0023 314	Thousand Oaks	California	United States	91360
7	Sl0023 302	Upland	California	United States	91786
8	Sl0023 326	New Haven	Connecticut	United States	06520
9	Sl0023 304	Clearwater	Florida	United States	33765
10	Sl0023 322	DeBary	Florida	United States	32713
11	Sl0023 301	Miami Lakes	Florida	United States	33014
12	Sl0023 321	Miami	Florida	United States	33136
13	Sl0023 319	Palm Harbor	Florida	United States	34684
14	Sl0023 310	Tampa	Florida	United States	33603
15	Sl0023 324	Atlanta	Georgia	United States	30303
16	Sl0023 327	Stockbridge	Georgia	United States	30281
17	Sl0023 320	Idaho Falls	Idaho	United States	83404
18	Sl0023 306	Albuquerque	New Mexico	United States	87104
19	Sl0023 313	Lake Success	New York	United States	11042
20	Sl0023 305	Oklahoma City	Oklahoma	United States	73101
21	Sl0023 315	Jackson	Tennessee	United States	38305
22	Sl0023 308	Memphis	Tennessee	United States	38119
23	Sl0023 317	Amarillo	Texas	United States	79124
24	Sl0023 303	Houston	Texas	United States	77034
25	Sl0023 328	Spokane	Washington	United States	99204
26	Sl0023 101	Plovdiv		Bulgaria
27	Sl0023 102	Plovdiv		Bulgaria
28	Sl0023 202	Providencia		Chile
29	Sl0023 203	Providencia		Chile
30	Sl0023 201	Puerto Varas		Chile
31	Sl0023 204	Vina del Mar		Chile
32	Sl0023 213	Barranquilla		Colombia
33	Sl0023 212	Bogotá		Colombia
34	Sl0023 214	Bogotá		Colombia
35	Sl0023 216	Bucaramanga		Colombia
36	Sl0023 211	Chía		Colombia
37	Sl0023 215	Medellín		Colombia
38	Sl0023 341	Hannover		Germany
39	Sl0023 113	Leipzig		Germany
40	Sl0023 124	Debrecen		Hungary
41	Sl0023 225	Guadalajara		Mexico
42	Sl0023 224	León		Mexico
43	Sl0023 221	Mexico		Mexico
44	Sl0023 222	San Luis Potosí		Mexico
45	Sl0023 232	Arequipa		Peru
46	Sl0023 231	Lima		Peru
47	Sl0023 234	Lima		Peru
48	Sl0023 235	Lima		Peru
49	Sl0023 133	Bytom		Poland
50	Sl0023 136	Lublin		Poland
51	Sl0023 131	Poznan		Poland
52	Sl0023 134	Sosnowiec		Poland
53	Sl0023 135	Warszawa		Poland
54	Sl0023 138	Łódź		Poland
55	Sl0023 146	Brasov		Romania
56	Sl0023 142	Bucuresti		Romania
57	Sl0023 144	Cluj-Napoca		Romania
58	Sl0023 141	Galati		Romania
59	Sl0023 157	Kazan		Russian Federation
60	Sl0023 156	Kemerovo		Russian Federation
61	Sl0023 152	Saint Petersburg		Russian Federation
62	Sl0023 155	Voronezh		Russian Federation
63	Sl0023 151	Yaroslavl'		Russian Federation
64	Sl0023 153	Yekaterinburg		Russian Federation
65	Sl0023 161	Barcelona		Spain
66	Sl0023 162	Madrid		Spain
67	Sl0023 166	Tenerife		Spain
68	Sl0023 172	Kyiv		Ukraine
69	Sl0023 175	Kyiv		Ukraine
70	Sl0023 171	Odessa		Ukraine
71	Sl0023 173	Vinnytsya		Ukraine

Sponsors and Collaborators

UCB Biopharma S.P.R.L.

Investigators

Study Director: UCB Cares, +1 844 599 2273 (UCB)

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

UCB Biopharma S.P.R.L.

ClinicalTrials.gov Identifier:

NCT02804763

Other Study ID Numbers:

SL0023
2015-004457-40

First Posted:

Jun 17, 2016

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Keywords provided by UCB Biopharma S.P.R.L.

Systemic Lupus Erythematosus (SLE)

Dapirolizumab Pegol (DZP)

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

Study Results

Participant Flow

Recruitment Details	The study started to enroll patients in June 2016 and concluded in November 2018.
Pre-assignment Detail	The study included a 4-week Screening Period, a 24-week Double-Blind Treatment Period and a 24-week Observational Period. Participant Flow refers to the Randomized Set.

Arm/Group Title	SOC + Placebo iv Q4W	SOC + DZP 6mg/kg iv Q4W	SOC + DZP 24mg/kg iv Q4W	SOC + DZP 45mg/kg iv Q4W
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
Period Title: Double-Blind Period (Week 1 to Week 24)
STARTED	45	45	45	47
Completed Week 24	44	45	44	45
Finished Wk24 Began Observational Period	44	44	44	45
COMPLETED	44	44	44	45
NOT COMPLETED	1	1	1	2
Period Title: Double-Blind Period (Week 1 to Week 24)
STARTED	44	44	44	45
COMPLETED	38	43	41	42
NOT COMPLETED	6	1	3	3

Baseline Characteristics

Arm/Group Title	SOC + Placebo iv Q4W	SOC + DZP 6mg/kg iv Q4W	SOC + DZP 24mg/kg iv Q4W	SOC + DZP 45mg/kg iv Q4W	Total Title
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
Overall Participants	45	45	45	47	182
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	44 97.8%	44 97.8%	44 97.8%	46 97.9%	178 97.8%
>=65 years	1 2.2%	1 2.2%	1 2.2%	1 2.1%	4 2.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.50 (12.79)	40.81 (11.55)	42.77 (10.42)	38.94 (12.92)	41.48 (12.01)
Sex: Female, Male (Count of Participants)
Female	41 91.1%	42 93.3%	40 88.9%	43 91.5%	166 91.2%
Male	4 8.9%	3 6.7%	5 11.1%	4 8.5%	16 8.8%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	2 4.4%	1 2.2%	1 2.2%	1 2.1%	5 2.7%
Asian	1 2.2%	0 0%	1 2.2%	0 0%	2 1.1%
Black	1 2.2%	4 8.9%	1 2.2%	6 12.8%	12 6.6%
White	27 60%	26 57.8%	33 73.3%	27 57.4%	113 62.1%
Other/Mixed	14 31.1%	14 31.1%	9 20%	13 27.7%	50 27.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24
Description	The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
The Full Analysis Set (FAS) consisted of all participants in the Randomized Set with the exception of 1 study participant who received less than 1 full dose during the study and 5 study participants who were randomized at Site 321. Missing values were imputed using a modified non-responder imputation (mNRI).

Arm/Group Title	SOC + Placebo iv Q4W (FAS)	SOC + DZP 6mg/kg iv Q4W (FAS)	SOC + DZP 24mg/kg iv Q4W (FAS)	SOC + DZP 45mg/kg iv Q4W (FAS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
Measure Participants	43	43	44	46
Number [percentage of participants]	0 0%	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 6mg/kg iv Q4W (FAS), SOC + DZP 24mg/kg iv Q4W (FAS), SOC + DZP 45mg/kg iv Q4W (FAS)
	Comments	Multiple contrast testing (MCP-mod methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo. The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	=0.0727
	Comments	The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response.
	Method	MCP-Mod
	Comments

2. Secondary Outcome

Title	The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24
Description	BICLA response was defined as meeting all of the following criteria: BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
The Full Analysis Set (FAS) consisted of all participants in the Randomized Set with the exception of 1 study participant who received less than 1 full dose during the study and 5 study participants who were randomized at Site 321. Missing values were imputed using a modified non-responder imputation (mNRI).

Arm/Group Title	SOC + Placebo iv Q4W (FAS)	SOC + DZP 6mg/kg iv Q4W (FAS)	SOC + DZP 24mg/kg iv Q4W (FAS)	SOC + DZP 45mg/kg iv Q4W (FAS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
Measure Participants	43	43	44	46
Number [percentage of participants]	37.2 82.7%	48.8 108.4%	54.5 121.1%	52.2 111.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 6mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	=0.2699
	Comments	Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95% 0.7 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 24mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	=0.1036
	Comments	Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95% 0.9 to 4.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 45mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	=0.1518
	Comments	Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.
	Method	Chi-squared
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95% 0.8 to 4.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 6mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference vs PBO
	Estimated Value	11.6
	Confidence Interval	(2-Sided) 95% -9.2 to 32.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 1 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 24mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference vs PBO
	Estimated Value	17.3
	Confidence Interval	(2-Sided) 95% -3.3 to 38.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 2 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 45mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference vs PBO
	Estimated Value	15.0
	Confidence Interval	(2-Sided) 95% -5.5 to 35.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 3 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 6mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference vs PBO
	Estimated Value	11.9
	Confidence Interval	(2-Sided) 95% -8.7 to 32.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 24mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference vs PBO
	Estimated Value	17.6
	Confidence Interval	(2-Sided) 95% -3.2 to 38.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SOC + Placebo iv Q4W (FAS), SOC + DZP 45mg/kg iv Q4W (FAS)
	Comments	Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference vs PBO
	Estimated Value	15.2
	Confidence Interval	(2-Sided) 95% -5.2 to 35.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants With at Least One Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Time Frame	From Baseline (Week 1) until end of the study (Week 48)

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Number [percentage of participants]	66.7 148.2%	66.7 148.2%	82.2 182.7%	74.5 158.5%

4. Secondary Outcome

Title	Percentage of Participants With a Serious Adverse Event (SAE)
Description	A Serious Adverse Event (SAE) must have met 1 or more of the following criteria: Death Life threatening Significant or persistent disability/incapacity Congenital anomaly/birth defect (including that occurring in a fetus) Important medical event that, based upon appropriate medical judgment, may have jeopardized the study participant, and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious Initial inpatient hospitalization or prolongation of hospitalization.
Time Frame	From Baseline (Week 1) until end of the study (Week 48)

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Number [percentage of participants]	13.3 29.6%	11.1 24.7%	13.3 29.6%	10.6 22.6%

5. Secondary Outcome

Title	Percentage of Participants With at Least One Adverse Events (AEs) of Interest
Description	Adverse events of interest (AEOI) were identified by the Investigator based on definitions per protocol, documented on the electronic Case Report Form (eCRF), adequately monitored, and source controlled. AEOI (regardless of seriousness): Moderate to severe infections, including opportunistic infections and tuberculosis (TB) Infusion reactions (including hypersensitivity and anaphylaxis) Thromboembolic events (including but not limited to cardiovascular events, stroke, myocardial infarction, pulmonary embolism, and deep vein thrombosis) Prespecified neurological events: severe and/or serious headache, positional headache, cranial nerve dysfunction, or signs and symptoms of meningitis (photophobia, neck stiffness) Malignancies.
Time Frame	From Baseline (Week 1) until end of the study (Week 48)

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Number [percentage of participants]	24.4 54.2%	26.7 59.3%	28.9 64.2%	25.5 54.3%

6. Secondary Outcome

Title	Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)
Description	An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Time Frame	From Baseline (Week 1) until end of the study (Week 48)

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Number [percentage of participants]	8.9 19.8%	0 0%	4.4 9.8%	4.3 9.1%

7. Secondary Outcome

Title	Mean Change From Baseline in Systolic Blood Pressure
Description	Blood pressure was measured in millimetre of mercury (mmHg).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	3.3 (12.9)	5.1 (10.5)	0.7 (10.7)	3.2 (9.9)
Week 4	0.6 (10.8)	1.0 (7.9)	-2.0 (8.9)	0.6 (12.4)
Week 6	0.3 (11.5)	4.0 (9.9)	2.3 (11.0)	2.4 (10.6)
Week 8	0.5 (12.4)	3.3 (12.6)	-2.4 (9.9)	-0.7 (11.9)
Week 12	-0.7 (10.1)	3.2 (10.5)	-3.0 (11.8)	0.8 (9.2)
Week 16	2.1 (12.3)	2.1 (11.6)	-2.8 (10.6)	0.9 (11.1)
Week 20	1.6 (9.9)	2.6 (9.8)	-1.7 (12.3)	1.5 (11.3)
Week 24	-0.7 (14.3)	1.1 (13.1)	0.3 (11.0)	3.6 (9.3)
Week 28	1.8 (12.3)	3.7 (13.1)	0.9 (10.5)	2.5 (11.8)
Week 32	2.2 (11.1)	3.0 (13.2)	0.4 (11.3)	4.3 (13.7)
Week 36	2.1 (11.0)	3.1 (12.6)	0.2 (10.5)	2.4 (12.9)
Week 40	-1.0 (14.1)	6.2 (12.9)	-2.0 (11.7)	2.5 (11.3)
Week 44	0.1 (12.6)	3.3 (14.1)	1.3 (10.4)	4.2 (11.8)
Week 48	-1.5 (11.5)	4.9 (14.3)	0.1 (10.2)	4.4 (12.0)

8. Secondary Outcome

Title	Mean Change From Baseline in Diastolic Blood Pressure
Description	Blood pressure was measured in millimetre of mercury (mmHg).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	2.1 (10.5)	1.4 (8.6)	1.5 (9.3)	2.4 (8.2)
Week 4	-0.7 (7.8)	-1.5 (6.3)	-1.7 (8.2)	-0.1 (8.3)
Week 6	1.0 (10.0)	1.5 (8.6)	1.8 (10.0)	1.9 (7.9)
Week 8	1.1 (9.2)	0.4 (9.1)	0.1 (8.6)	1.0 (8.0)
Week 12	-0.9 (8.4)	-0.3 (6.9)	-2.2 (9.6)	-0.3 (6.9)
Week 16	-0.3 (8.9)	-1.3 (7.6)	-0.7 (9.5)	-0.1 (7.0)
Week 20	1.5 (8.1)	-1.1 (8.7)	-0.7 (9.6)	0.9 (8.8)
Week 24	1.9 (11.2)	1.6 (8.7)	2.3 (10.7)	0.6 (8.7)
Week 28	1.5 (9.1)	-0.2 (8.8)	1.4 (8.4)	2.5 (8.4)
Week 32	2.3 (10.1)	2.8 (9.3)	0.7 (10.2)	2.3 (8.1)
Week 36	3.4 (9.8)	1.4 (10.2)	1.4 (8.4)	2.2 (8.0)
Week 40	1.0 (9.2)	2.6 (7.6)	0.5 (9.9)	3.6 (8.8)
Week 44	0.8 (10.2)	1.5 (8.1)	0.4 (9.4)	2.2 (10.3)
Week 48	1.4 (9.0)	2.3 (8.8)	1.1 (9.4)	2.4 (8.6)

9. Secondary Outcome

Title	Mean Change From Baseline in Pulse Rate
Description	Pulse Rate was measured in beats per minute (beats/min).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.2 (8.3)	0.2 (10.4)	2.3 (9.7)	-0.9 (10.4)
Week 4	1.7 (9.6)	1.5 (8.0)	0.4 (8.4)	-3.3 (9.7)
Week 6	-0.7 (10.2)	0.1 (8.5)	0.8 (8.9)	-0.6 (8.8)
Week 8	1.3 (9.0)	0.3 (9.2)	1.4 (10.2)	-2.6 (10.2)
Week 12	0.6 (10.3)	1.1 (9.8)	-0.3 (10.4)	-1.5 (9.7)
Week 16	-0.8 (9.2)	0.3 (8.9)	0.9 (10.7)	-1.6 (10.6)
Week 20	0.3 (10.6)	1.1 (9.9)	0.8 (9.5)	0.4 (6.6)
Week 24	-1.5 (10.7)	0.8 (10.9)	-0.3 (10.2)	-1.0 (8.7)
Week 28	0.6 (11.8)	1.3 (10.9)	0.0 (9.2)	0.6 (8.8)
Week 32	0.4 (9.8)	1.3 (10.9)	0.8 (11.4)	-2.1 (11.0)
Week 36	-0.7 (10.9)	0.2 (8.3)	0.7 (10.4)	-0.2 (9.8)
Week 40	-0.1 (10.9)	-0.1 (9.8)	0.6 (10.2)	-1.3 (9.6)
Week 44	-0.2 (10.2)	-0.1 (9.8)	0.3 (11.7)	-0.6 (8.9)
Week 48	-0.2 (11.1)	-0.7 (10.6)	-0.9 (11.9)	-2.0 (7.7)

10. Secondary Outcome

Title	Mean Change From Baseline in Temperature
Description	Temperature was measured in Grad Celsius (°C).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.1 (0.4)	0.0 (0.3)	0.1 (0.5)	0.0 (0.4)
Week 4	-0.1 (0.4)	0.0 (0.4)	0.0 (0.4)	0.0 (0.3)
Week 6	-0.2 (0.5)	0.0 (0.4)	0.1 (0.5)	0.0 (0.5)
Week 8	-0.1 (0.4)	-0.1 (0.3)	0.0 (0.4)	0.0 (0.4)
Week 12	-0.1 (0.4)	-0.1 (0.4)	0.0 (0.3)	0.0 (0.4)
Week 16	-0.1 (0.4)	0.0 (0.4)	0.0 (0.4)	0.0 (0.3)
Week 20	-0.1 (0.4)	0.0 (0.4)	0.0 (0.4)	0.0 (0.5)
Week 24	-0.1 (0.5)	0.0 (0.4)	0.1 (0.5)	0.0 (0.4)
Week 28	0.0 (0.4)	0.0 (0.4)	0.1 (0.5)	0.1 (0.5)
Week 32	0.0 (0.4)	0.0 (0.4)	0.1 (0.5)	0.0 (0.4)
Week 36	-0.1 (0.3)	0.0 (0.6)	0.0 (0.4)	0.1 (0.4)
Week 40	0.0 (0.4)	0.0 (0.4)	0.0 (0.5)	0.1 (0.3)
Week 44	0.0 (0.6)	0.0 (0.5)	0.1 (0.4)	0.0 (0.4)
Week 48	-0.1 (0.4)	0.0 (0.4)	0.0 (0.5)	0.0 (0.4)

11. Secondary Outcome

Title	Mean Change From Baseline in Weight
Description	Weight was measured in kilograms (kg).
Time Frame	Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 4	0.0 (1.0)	0.2 (1.0)	0.4 (0.9)	0.3 (1.2)
Week 8	0.3 (1.9)	0.6 (1.4)	0.6 (1.8)	0.4 (1.8)
Week 12	0.4 (2.3)	0.5 (1.6)	0.5 (2.0)	0.6 (2.3)
Week 16	0.3 (2.3)	0.7 (2.3)	0.8 (2.3)	0.5 (2.4)
Week 20	0.3 (2.4)	0.7 (2.6)	1.0 (2.6)	0.5 (2.8)

12. Secondary Outcome

Title	Mean Change From Baseline in Height
Description	Height was measured in centimeters (cm).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Mean (Standard Deviation) [cm]	NA (NA)	NA (NA)	NA (NA)	NA (NA)

13. Secondary Outcome

Title	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Description	Twelve-lead ECG assessments should have been performed prior to dosing (if applicable) and prior to obtaining pharmacokinetic (PK) or other laboratory samples. Electrocardiograms were recorded digitally and read by the Investigator for recording in the electronic Case Report Form (eCRF).
Time Frame	Screening, Week 4, Week 24, Week 28 and Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Screening	8 17.8%	11 24.4%	6 13.3%	6 12.8%
Week 4	11 24.4%	12 26.7%	7 15.6%	10 21.3%
Week 24	9 20%	7 15.6%	6 13.3%	10 21.3%
Week 28	1 2.2%	0 0%	0 0%	0 0%
Week 48	8 17.8%	7 15.6%	11 24.4%	9 19.1%

14. Secondary Outcome

Title	Mean Change From Baseline in Hemoglobin
Description	Hemoglobin was measured in grams per liter (g/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.4 (6.4)	-1.8 (5.8)	-0.7 (6.9)	-0.7 (6.8)
Week 4	-1.0 (7.2)	-0.7 (7.7)	-1.4 (8.6)	-0.8 (5.8)
Week 8	-0.3 (7.3)	-1.9 (7.9)	-1.9 (8.6)	-1.3 (7.4)
Week 12	-0.5 (9.5)	-0.5 (8.5)	-0.5 (10.1)	0.2 (8.3)
Week 16	0.3 (10.4)	-0.3 (10.0)	-0.8 (10.6)	-2.7 (8.3)
Week 20	-0.7 (11.5)	0.3 (9.9)	-0.5 (10.1)	-2.4 (7.2)
Week 24	-0.4 (9.7)	-0.7 (11.2)	-0.7 (10.5)	-2.9 (8.1)
Week 28	0.7 (10.6)	-3.4 (11.0)	0.0 (14.1)	-3.1 (9.5)
Week 32	1.6 (12.5)	-1.3 (9.8)	1.0 (12.5)	-1.3 (9.6)
Week 40	0.7 (13.5)	-0.3 (13.5)	1.9 (14.9)	1.1 (11.0)
Week 48	-0.5 (14.3)	-1.5 (11.6)	0.9 (12.5)	-0.7 (10.0)

15. Secondary Outcome

Title	Mean Change From Baseline in Hematocrit
Description	Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.42 (2.52)	-0.25 (2.26)	-0.32 (2.37)	0.00 (2.71)
Week 4	-0.46 (2.29)	-0.17 (2.75)	-0.79 (2.92)	-0.11 (2.31)
Week 8	-0.27 (2.23)	-0.12 (2.94)	-0.86 (2.72)	-0.42 (2.31)
Week 12	-0.23 (2.67)	-0.13 (2.72)	-0.32 (3.39)	-0.02 (2.54)
Week 16	-0.12 (2.86)	0.05 (3.25)	-0.57 (3.32)	-0.84 (2.95)
Week 20	-0.41 (3.20)	0.13 (2.99)	-0.42 (3.32)	-0.80 (2.83)
Week 24	-0.09 (2.61)	-0.40 (3.19)	-0.29 (3.14)	-0.76 (2.33)
Week 28	0.03 (2.98)	-1.02 (3.23)	-0.22 (3.99)	-0.89 (2.47)
Week 32	0.29 (2.89)	-0.62 (2.86)	0.17 (3.43)	-0.21 (2.82)
Week 40	-0.20 (3.32)	-0.24 (4.37)	0.58 (4.11)	0.37 (2.72)
Week 48	-0.59 (3.51)	-0.37 (3.58)	-0.08 (3.21)	-0.11 (2.54)

16. Secondary Outcome

Title	Mean Change From Baseline in Erythrocytes
Description	Erythrocytes was measured in number of erythrocytes per liter (10^12/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.004 (0.246)	-0.035 (0.237)	-0.032 (0.223)	-0.028 (0.237)
Week 4	-0.080 (0.243)	-0.018 (0.293)	-0.052 (0.273)	-0.033 (0.210)
Week 8	-0.039 (0.224)	-0.039 (0.280)	-0.069 (0.262)	-0.044 (0.242)
Week 12	-0.024 (0.271)	0.014 (0.292)	-0.010 (0.267)	0.019 (0.226)
Week 16	-0.002 (0.312)	0.041 (0.360)	0.000 (0.302)	-0.051 (0.265)
Week 20	-0.029 (0.333)	0.062 (0.309)	-0.001 (0.325)	-0.047 (0.302)
Week 24	0.005 (0.308)	0.036 (0.312)	0.013 (0.319)	-0.038 (0.240)
Week 28	0.018 (0.340)	-0.040 (0.304)	0.019 (0.346)	-0.050 (0.270)
Week 32	0.048 (0.320)	0.001 (0.284)	0.032 (0.289)	0.027 (0.277)
Week 40	-0.005 (0.343)	0.042 (0.382)	0.054 (0.368)	0.060 (0.256)
Week 48	-0.024 (0.332)	-0.018 (0.295)	0.017 (0.299)	-0.028 (0.245)

17. Secondary Outcome

Title	Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Description	Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	1.01 (2.28)	0.24 (2.40)	-0.09 (2.66)	0.45 (2.96)
Week 4	0.60 (2.35)	0.08 (2.66)	-0.68 (2.10)	0.40 (3.02)
Week 8	0.23 (3.48)	-0.30 (5.36)	-0.54 (2.85)	-0.16 (2.79)
Week 12	0.06 (3.57)	-0.52 (3.44)	-0.55 (4.67)	-0.57 (3.09)
Week 16	-0.25 (3.41)	-0.65 (4.38)	-1.38 (4.87)	-0.97 (3.62)
Week 20	-0.37 (3.73)	-0.92 (4.58)	-1.00 (5.01)	-0.97 (3.54)
Week 24	-0.23 (3.83)	-1.63 (4.07)	-0.92 (6.51)	-1.05 (4.00)
Week 28	-0.33 (3.61)	-1.40 (4.61)	-0.96 (6.46)	-1.21 (4.91)
Week 32	-0.27 (4.45)	-1.33 (4.32)	-0.45 (6.81)	-1.06 (4.69)
Week 40	-0.36 (5.34)	-1.46 (4.72)	0.07 (6.27)	-0.24 (4.85)
Week 48	-0.98 (5.34)	-0.50 (4.97)	-0.63 (6.92)	0.34 (4.31)

18. Secondary Outcome

Title	Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Description	Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-2.3 (9.8)	-2.6 (10.9)	0.7 (9.8)	-1.9 (10.1)
Week 4	1.4 (8.7)	-0.9 (10.1)	2.7 (8.6)	-1.2 (12.5)
Week 8	1.7 (11.5)	-3.8 (13.4)	2.1 (8.2)	-0.1 (11.5)
Week 12	0.5 (11.1)	-0.6 (10.7)	0.6 (12.3)	0.5 (12.7)
Week 16	1.6 (13.8)	-1.5 (10.1)	2.3 (11.3)	-0.2 (14.1)
Week 20	1.6 (12.9)	-0.9 (11.3)	2.4 (11.2)	0.4 (12.6)
Week 24	0.0 (13.7)	1.0 (13.2)	0.4 (12.8)	-1.2 (13.1)
Week 28	1.6 (13.4)	-1.3 (14.4)	1.7 (13.8)	-0.6 (16.5)
Week 32	1.7 (18.9)	1.1 (13.8)	1.2 (15.0)	-1.4 (16.0)
Week 40	3.4 (17.6)	0.8 (16.5)	0.1 (15.8)	0.1 (15.4)
Week 48	3.6 (17.1)	-0.6 (16.2)	2.9 (14.5)	0.0 (13.5)

19. Secondary Outcome

Title	Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Description	Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.12 (0.71)	-0.18 (0.65)	0.04 (0.43)	0.00 (0.47)
Week 4	0.31 (0.63)	-0.06 (0.79)	0.04 (0.64)	0.02 (0.65)
Week 8	0.20 (0.87)	-0.25 (0.87)	0.04 (0.81)	-0.04 (0.74)
Week 12	0.04 (1.08)	-0.25 (1.03)	-0.09 (1.25)	-0.12 (0.90)
Week 16	0.03 (1.43)	-0.36 (1.31)	-0.20 (1.52)	-0.31 (1.19)
Week 20	0.00 (1.49)	-0.39 (1.40)	-0.10 (1.63)	-0.26 (1.24)
Week 24	-0.13 (1.57)	-0.43 (1.39)	-0.25 (1.96)	-0.44 (1.42)
Week 28	0.01 (1.68)	-0.55 (1.45)	-0.15 (2.09)	-0.44 (1.68)
Week 32	0.01 (2.12)	-0.33 (1.28)	-0.06 (2.39)	-0.48 (1.63)
Week 40	0.17 (2.50)	-0.40 (1.30)	0.03 (2.32)	-0.09 (2.00)
Week 48	0.02 (2.58)	-0.21 (1.48)	0.06 (2.55)	0.10 (1.90)

20. Secondary Outcome

Title	Mean Change From Baseline in Leukocytes
Description	Leukocytes was measured in number of leukocytes per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.34 (2.45)	0.27 (1.23)	0.49 (1.46)	0.20 (1.62)
Week 4	0.10 (1.88)	0.27 (1.63)	0.25 (1.47)	0.52 (2.11)
Week 8	-0.25 (2.12)	0.46 (1.41)	-0.05 (1.50)	-0.10 (1.65)
Week 12	-0.27 (1.80)	0.18 (1.73)	0.17 (2.00)	0.23 (2.01)
Week 16	-0.31 (2.18)	0.13 (1.55)	0.21 (1.69)	-0.20 (2.12)
Week 20	-0.24 (2.27)	-0.06 (1.59)	-0.22 (1.74)	0.30 (2.61)
Week 24	-0.22 (2.41)	-0.12 (1.83)	-0.14 (1.75)	-0.34 (1.97)
Week 28	0.05 (2.04)	0.06 (1.93)	0.26 (2.04)	-0.58 (1.70)
Week 32	-0.14 (2.20)	0.08 (1.64)	0.19 (1.67)	-0.44 (1.68)
Week 40	0.17 (2.54)	0.04 (1.60)	-0.35 (1.49)	-0.49 (1.96)
Week 48	-0.49 (1.83)	0.30 (1.53)	-0.14 (2.06)	-0.62 (1.87)

21. Secondary Outcome

Title	Mean Change From Baseline in Basophils
Description	Basophils was measured in number of basophils per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.01 (0.03)	0.02 (0.04)	0.00 (0.03)	0.00 (0.02)
Week 4	0.01 (0.03)	0.00 (0.03)	0.01 (0.04)	0.00 (0.02)
Week 8	0.01 (0.04)	0.01 (0.04)	0.01 (0.03)	0.00 (0.02)
Week 12	0.01 (0.03)	0.01 (0.04)	0.00 (0.03)	0.00 (0.03)
Week 16	0.01 (0.04)	0.00 (0.03)	0.01 (0.03)	0.00 (0.03)
Week 20	0.00 (0.03)	0.01 (0.03)	0.00 (0.03)	0.00 (0.03)
Week 24	0.00 (0.03)	0.02 (0.04)	0.00 (0.03)	0.00 (0.03)
Week 28	0.02 (0.05)	0.01 (0.04)	0.00 (0.02)	0.00 (0.03)
Week 32	0.00 (0.03)	0.00 (0.02)	0.01 (0.03)	0.00 (0.03)
Week 40	0.00 (0.02)	0.00 (0.02)	0.01 (0.03)	0.00 (0.03)
Week 48	0.00 (0.03)	0.00 (0.02)	0.00 (0.03)	0.01 (0.03)

22. Secondary Outcome

Title	Mean Change From Baseline in Basophils/Leukocytes
Description	Basophils/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.05 (0.23)	0.02 (0.20)	-0.05 (0.31)	-0.03 (0.27)
Week 4	0.03 (0.27)	-0.06 (0.26)	-0.01 (0.43)	-0.07 (0.26)
Week 8	0.08 (0.42)	0.03 (0.32)	0.00 (0.33)	-0.06 (0.23)
Week 12	0.04 (0.30)	0.09 (0.48)	0.00 (0.25)	-0.07 (0.28)
Week 16	0.01 (0.25)	0.00 (0.28)	-0.02 (0.31)	-0.05 (0.30)
Week 20	-0.02 (0.26)	0.00 (0.27)	-0.07 (0.29)	-0.04 (0.32)
Week 24	-0.04 (0.31)	0.15 (0.44)	-0.03 (0.24)	-0.03 (0.21)
Week 28	0.08 (0.54)	0.03 (0.29)	0.00 (0.24)	0.07 (0.32)
Week 32	-0.03 (0.29)	0.00 (0.23)	0.01 (0.25)	0.01 (0.25)
Week 40	-0.08 (0.24)	-0.03 (0.25)	0.07 (0.29)	0.01 (0.29)
Week 48	-0.01 (0.29)	-0.08 (0.21)	0.02 (0.25)	0.06 (0.28)

23. Secondary Outcome

Title	Mean Change From Baseline in Eosinophils
Description	Eosinophils was measured in number of eosinophils per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.01 (0.04)	0.01 (0.06)	0.00 (0.09)	-0.01 (0.05)
Week 4	-0.01 (0.04)	-0.01 (0.06)	0.00 (0.04)	-0.01 (0.04)
Week 8	-0.01 (0.04)	0.03 (0.16)	0.00 (0.04)	0.01 (0.07)
Week 12	0.00 (0.04)	0.04 (0.20)	0.02 (0.10)	0.02 (0.17)
Week 16	0.00 (0.05)	0.02 (0.11)	0.01 (0.05)	0.00 (0.06)
Week 20	0.00 (0.05)	0.04 (0.24)	0.01 (0.05)	-0.01 (0.05)
Week 24	-0.01 (0.05)	0.04 (0.15)	0.02 (0.07)	-0.02 (0.06)
Week 28	-0.01 (0.04)	0.01 (0.07)	0.01 (0.05)	0.00 (0.06)
Week 32	-0.01 (0.06)	0.01 (0.10)	0.01 (0.05)	-0.02 (0.04)
Week 40	0.00 (0.05)	0.01 (0.06)	0.02 (0.06)	0.00 (0.07)
Week 48	0.00 (0.04)	-0.01 (0.05)	0.00 (0.06)	0.00 (0.06)

24. Secondary Outcome

Title	Mean Change From Baseline in Eosinophils/Leukocytes
Description	Eosinophils/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.19 (1.07)	0.07 (0.86)	-0.18 (1.13)	-0.29 (1.22)
Week 4	-0.32 (0.96)	-0.05 (1.26)	-0.12 (1.01)	-0.26 (0.94)
Week 8	-0.05 (1.09)	0.54 (2.13)	0.10 (1.11)	0.22 (1.89)
Week 12	0.18 (1.03)	0.70 (3.12)	0.33 (1.68)	0.05 (1.83)
Week 16	0.06 (1.05)	0.36 (1.24)	0.20 (1.40)	-0.11 (1.33)
Week 20	0.04 (1.11)	0.83 (3.58)	0.11 (1.24)	-0.39 (1.29)
Week 24	0.11 (1.16)	0.82 (2.89)	-0.01 (1.22)	0.06 (1.63)
Week 28	0.06 (1.00)	0.21 (1.33)	0.18 (1.02)	-0.03 (1.35)
Week 32	0.02 (1.09)	0.28 (1.60)	0.16 (1.13)	-0.20 (1.03)
Week 40	-0.10 (0.85)	0.05 (1.09)	0.40 (1.23)	-0.09 (1.47)
Week 48	0.09 (1.02)	-0.17 (1.08)	0.06 (0.90)	0.24 (1.03)

25. Secondary Outcome

Title	Mean Change From Baseline in Lymphocytes
Description	Lymphocytes was measured in number of lymphocytes per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.03 (0.39)	0.05 (0.36)	0.16 (0.29)	0.24 (0.37)
Week 4	-0.04 (0.36)	-0.01 (0.47)	-0.01 (0.41)	0.23 (0.42)
Week 8	-0.15 (0.48)	-0.03 (0.39)	0.06 (0.46)	0.14 (0.50)
Week 12	-0.06 (0.43)	0.02 (0.59)	0.01 (0.42)	0.21 (0.51)
Week 16	-0.09 (0.52)	-0.11 (0.51)	-0.02 (0.47)	0.04 (0.40)
Week 20	-0.14 (0.56)	-0.13 (0.54)	0.02 (0.39)	0.13 (0.55)
Week 24	-0.11 (0.51)	-0.08 (0.60)	-0.03 (0.45)	0.05 (0.52)
Week 28	-0.04 (0.57)	-0.02 (0.59)	0.01 (0.53)	0.03 (0.56)
Week 32	-0.11 (0.57)	-0.16 (0.59)	0.05 (0.45)	-0.02 (0.44)
Week 40	-0.11 (0.54)	-0.11 (0.52)	-0.11 (0.43)	-0.03 (0.48)
Week 48	-0.19 (0.68)	-0.19 (0.60)	-0.10 (0.44)	-0.02 (0.49)

26. Secondary Outcome

Title	Mean Change From Baseline in Lymphocytes/Leukocytes
Description	Lymphocytes/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-1.88 (9.01)	0.19 (6.55)	1.18 (6.09)	2.61 (6.11)
Week 4	-0.88 (7.09)	-1.02 (6.34)	-1.18 (9.93)	0.97 (8.00)
Week 8	-1.98 (10.59)	-1.40 (7.13)	0.56 (10.20)	1.97 (8.51)
Week 12	0.21 (7.87)	0.56 (10.58)	-0.44 (9.90)	2.46 (10.18)
Week 16	-0.91 (8.33)	-1.49 (7.50)	-1.18 (9.65)	0.12 (9.34)
Week 20	-1.97 (10.37)	-0.66 (6.58)	0.88 (10.69)	0.71 (10.32)
Week 24	-0.75 (8.69)	-0.56 (7.35)	-0.52 (10.55)	1.85 (9.67)
Week 28	-1.18 (8.27)	-0.05 (8.51)	-0.05 (9.97)	1.61 (10.55)
Week 32	-1.59 (7.69)	-2.56 (6.51)	-0.16 (7.70)	0.70 (8.74)
Week 40	-2.60 (9.18)	-2.02 (5.99)	-1.36 (10.12)	0.33 (8.41)
Week 48	-1.46 (11.29)	-3.71 (7.41)	-0.84 (9.42)	1.69 (10.05)

27. Secondary Outcome

Title	Mean Change From Baseline in Monocytes
Description	Monocytes was measured in number of monocytes per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.01 (0.17)	0.01 (0.18)	0.05 (0.14)	0.01 (0.13)
Week 4	0.01 (0.18)	0.04 (0.18)	0.01 (0.14)	0.06 (0.19)
Week 8	-0.03 (0.18)	0.04 (0.18)	0.03 (0.16)	0.02 (0.17)
Week 12	-0.01 (0.19)	0.00 (0.14)	0.04 (0.18)	0.06 (0.15)
Week 16	-0.01 (0.17)	0.01 (0.17)	0.05 (0.18)	0.03 (0.14)
Week 20	-0.03 (0.19)	0.00 (0.16)	0.00 (0.13)	0.05 (0.19)
Week 24	0.00 (0.19)	0.04 (0.19)	0.03 (0.17)	0.00 (0.17)
Week 28	0.00 (0.20)	0.04 (0.21)	0.08 (0.19)	0.02 (0.17)
Week 32	-0.01 (0.18)	0.02 (0.19)	0.05 (0.23)	-0.01 (0.19)
Week 40	0.03 (0.17)	0.05 (0.16)	0.04 (0.16)	-0.01 (0.18)
Week 48	-0.02 (0.20)	-0.01 (0.13)	0.03 (0.15)	-0.02 (0.18)

28. Secondary Outcome

Title	Mean Change From Baseline in Monocytes/Leukocytes
Description	Monocytes/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.87 (2.50)	-0.07 (2.46)	0.23 (3.03)	-0.37 (2.25)
Week 4	0.26 (3.30)	0.27 (2.41)	-0.16 (3.11)	-0.24 (2.82)
Week 8	-0.21 (3.47)	0.07 (3.61)	0.51 (3.83)	0.08 (3.12)
Week 12	0.07 (2.79)	-0.11 (2.38)	0.22 (3.37)	0.45 (2.74)
Week 16	0.06 (3.30)	0.59 (2.85)	0.43 (3.31)	0.28 (3.13)
Week 20	-0.27 (3.84)	0.56 (3.08)	0.33 (3.81)	0.43 (3.39)
Week 24	0.06 (3.45)	0.84 (2.97)	0.46 (3.00)	0.41 (3.24)
Week 28	-0.24 (3.54)	0.69 (3.24)	0.64 (3.67)	0.94 (3.78)
Week 32	-0.08 (3.11)	0.13 (2.62)	0.46 (3.91)	-0.03 (3.76)
Week 40	0.49 (3.55)	0.64 (2.92)	0.83 (3.69)	0.59 (3.07)
Week 48	-0.04 (3.79)	-0.13 (2.41)	0.47 (3.82)	0.29 (3.30)

29. Secondary Outcome

Title	Mean Change From Baseline in Neutrophils
Description	Neutrophils was measured in number of neutrophils per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.28 (2.43)	0.26 (1.17)	0.17 (1.33)	-0.01 (1.46)
Week 4	0.07 (1.82)	0.27 (1.40)	0.21 (1.64)	0.23 (1.96)
Week 8	-0.13 (2.20)	0.41 (1.32)	-0.07 (1.53)	-0.20 (1.49)
Week 12	-0.24 (1.56)	0.20 (1.65)	0.10 (1.94)	-0.01 (2.03)
Week 16	-0.22 (2.13)	0.20 (1.41)	0.15 (1.61)	-0.20 (2.14)
Week 20	-0.07 (2.21)	0.01 (1.22)	-0.39 (1.69)	0.09 (2.51)
Week 24	-0.12 (2.24)	-0.06 (1.54)	-0.16 (1.77)	-0.38 (1.92)
Week 28	0.04 (1.81)	0.13 (1.64)	0.10 (1.91)	-0.62 (1.78)
Week 32	-0.07 (1.87)	0.33 (1.27)	0.07 (1.54)	-0.40 (1.67)
Week 40	0.16 (2.37)	0.16 (1.31)	-0.32 (1.57)	-0.41 (1.88)
Week 48	-0.29 (1.58)	0.55 (1.15)	-0.09 (2.02)	-0.54 (1.78)

30. Secondary Outcome

Title	Mean Change From Baseline in Neutrophils/Leukocytes
Description	Neutrophils/Leukocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	2.99 (10.73)	-0.21 (7.94)	-1.20 (8.40)	-1.93 (8.18)
Week 4	0.91 (9.37)	0.89 (7.82)	1.47 (12.70)	-0.37 (10.27)
Week 8	2.15 (12.95)	0.79 (8.80)	-1.17 (13.28)	-2.23 (10.92)
Week 12	-0.52 (9.44)	-1.25 (11.78)	-0.12 (13.18)	-2.90 (12.85)
Week 16	0.77 (11.02)	0.54 (8.50)	0.56 (12.48)	-0.24 (12.23)
Week 20	2.22 (13.21)	-0.73 (8.42)	-1.25 (14.29)	-0.71 (13.91)
Week 24	0.65 (11.48)	-1.25 (8.74)	0.10 (13.20)	-2.30 (12.41)
Week 28	1.28 (10.38)	-0.88 (10.56)	-0.77 (13.27)	-2.60 (13.79)
Week 32	1.67 (9.93)	2.15 (7.42)	-0.47 (9.80)	-0.48 (12.08)
Week 40	2.29 (11.66)	1.36 (6.95)	0.07 (13.23)	-0.93 (11.50)
Week 48	1.41 (13.58)	4.09 (8.40)	0.30 (12.47)	-2.28 (12.38)

31. Secondary Outcome

Title	Mean Change From Baseline in Platelets
Description	Platelets was measured in number of platelets per liter (10^9/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	5.9 (33.2)	10.0 (40.0)	1.4 (47.5)	-1.0 (52.0)
Week 4	-5.2 (51.3)	0.0 (32.4)	4.9 (43.8)	8.1 (42.6)
Week 8	0.2 (45.3)	-0.3 (40.3)	3.9 (52.0)	-6.4 (40.5)
Week 12	-4.3 (50.6)	-1.7 (38.8)	-2.7 (49.0)	1.8 (49.4)
Week 16	0.7 (57.7)	-0.7 (40.5)	-1.5 (66.7)	-2.3 (68.1)
Week 20	9.2 (57.1)	-3.3 (43.0)	0.5 (44.6)	0.8 (64.4)
Week 24	0.2 (60.2)	-5.2 (43.8)	2.4 (68.6)	1.7 (67.0)
Week 28	3.6 (64.6)	1.8 (52.6)	-5.8 (71.9)	1.5 (64.4)
Week 32	4.0 (71.8)	-1.9 (55.4)	-4.6 (57.5)	9.9 (93.8)
Week 40	10.3 (74.9)	14.2 (52.7)	-8.8 (63.2)	-1.5 (67.4)
Week 48	7.1 (67.4)	3.5 (58.2)	-9.5 (70.9)	-8.8 (66.5)

32. Secondary Outcome

Title	Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Description	Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	33.0 (313.6)	77.7 (383.6)	106.6 (283.1)	126.9 (338.9)
Week 4	-30.6 (293.5)	-47.7 (504.3)	24.0 (394.9)	227.2 (412.1)
Week 8	-64.7 (405.7)	-58.6 (422.8)	-20.5 (403.2)	78.3 (560.0)
Week 12	-44.2 (283.2)	-48.8 (452.1)	-57.8 (385.1)	43.7 (599.3)
Week 16	-81.9 (479.4)	-141.2 (516.1)	-4.5 (383.2)	-45.4 (520.8)
Week 20	-92.7 (391.1)	-173.4 (490.9)	5.9 (352.9)	-89.9 (577.7)
Week 24	-85.8 (472.5)	-128.9 (569.4)	-88.5 (462.1)	-78.3 (570.7)
Week 28	-27.6 (507.3)	-81.2 (652.7)	46.1 (482.2)	7.4 (561.2)
Week 32	-70.9 (428.4)	-173.6 (565.8)	18.0 (415.0)	-90.5 (504.0)
Week 40	-110.5 (526.4)	-166.9 (542.2)	-1.8 (410.7)	31.7 (528.8)
Week 48	-115.6 (581.1)	-253.1 (637.0)	36.1 (492.3)	22.3 (558.0)

33. Secondary Outcome

Title	Mean Change From Baseline in CD3/Lymphocytes
Description	CD3/Lymphocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.7 (6.1)	-0.9 (4.6)	-2.0 (5.7)	-0.2 (7.8)
Week 4	-2.1 (7.3)	-0.5 (6.0)	-1.9 (5.0)	-0.5 (6.8)
Week 8	-0.9 (6.1)	-1.2 (4.8)	-2.6 (5.9)	0.6 (9.5)
Week 12	-0.4 (5.6)	-1.1 (8.2)	-2.4 (6.0)	-0.1 (9.2)
Week 16	-1.9 (5.8)	-1.6 (7.8)	-1.9 (7.6)	-1.4 (7.9)
Week 20	-0.8 (5.0)	0.0 (8.6)	-2.3 (6.9)	0.6 (9.2)
Week 24	0.0 (6.5)	-0.1 (8.8)	-1.8 (6.6)	18.7 (114.3)
Week 28	-0.2 (6.9)	0.2 (8.3)	-2.9 (7.2)	0.9 (10.2)
Week 32	-1.3 (7.0)	0.2 (7.9)	-1.8 (6.8)	1.4 (8.5)
Week 40	0.2 (6.7)	1.4 (6.9)	0.5 (6.5)	3.3 (7.9)
Week 48	1.3 (8.0)	0.3 (7.6)	0.1 (6.2)	4.5 (7.3)

34. Secondary Outcome

Title	Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Description	Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	9.6 (56.7)	12.3 (76.2)	24.8 (71.0)	63.4 (133.5)
Week 4	-2.8 (46.3)	-31.2 (177.0)	9.2 (60.5)	82.8 (154.5)
Week 8	-13.3 (72.9)	-29.4 (183.5)	8.7 (70.8)	19.4 (146.4)
Week 12	-2.6 (83.4)	-48.1 (207.1)	-17.9 (77.8)	53.2 (203.6)
Week 16	-12.5 (84.3)	-50.1 (201.5)	-10.0 (92.4)	13.2 (147.8)
Week 20	-15.1 (86.0)	-75.4 (216.6)	-2.5 (57.1)	2.7 (132.6)
Week 24	-15.0 (89.3)	-77.2 (231.9)	-20.3 (72.0)	-1.1 (135.0)
Week 28	-20.6 (106.7)	-69.6 (206.7)	-13.1 (84.5)	-13.0 (123.2)
Week 32	-14.3 (106.3)	-75.8 (225.7)	-10.4 (93.0)	-20.9 (168.1)
Week 40	-24.8 (103.3)	-68.6 (211.0)	-26.9 (83.0)	-46.9 (138.0)
Week 48	-37.0 (132.7)	-82.4 (243.7)	-15.5 (83.2)	-41.2 (120.0)

35. Secondary Outcome

Title	Mean Change From Baseline in CD19/Lymphocytes
Description	CD19/Lymphocytes was measured in percentages (%).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.3 (2.1)	-0.1 (3.0)	1.0 (3.5)	1.5 (5.9)
Week 4	0.0 (2.9)	-0.5 (3.7)	0.7 (3.3)	2.8 (5.7)
Week 8	0.1 (2.8)	-0.5 (4.2)	0.7 (2.5)	0.4 (6.4)
Week 12	-0.2 (3.2)	-1.0 (3.9)	-0.4 (3.1)	1.7 (7.9)
Week 16	0.0 (4.7)	-1.2 (5.0)	-0.4 (3.3)	0.7 (5.9)
Week 20	-0.4 (3.8)	-2.1 (6.2)	-0.3 (3.0)	-0.2 (6.9)
Week 24	-0.9 (4.5)	-2.0 (6.5)	-0.6 (3.3)	-0.3 (7.3)
Week 28	-1.2 (5.4)	-2.5 (5.9)	-1.1 (3.3)	-1.0 (6.6)
Week 32	-0.4 (4.7)	-2.4 (5.5)	-0.6 (4.4)	-1.6 (6.3)
Week 40	-1.2 (4.7)	-2.6 (5.4)	-1.9 (4.2)	-3.4 (6.7)
Week 48	-1.2 (6.8)	-2.6 (7.2)	-1.6 (4.9)	-3.3 (6.2)

36. Secondary Outcome

Title	Mean Change From Baseline in Aspartate Aminotransferase
Description	Aspartate Aminotransferase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.5 (8.8)	0.2 (8.0)	4.3 (43.1)	0.0 (7.2)
Week 4	-0.1 (11.2)	0.2 (7.4)	-1.1 (7.6)	-1.9 (8.0)
Week 8	-0.1 (8.7)	-1.5 (6.2)	0.5 (13.0)	-1.1 (8.1)
Week 12	5.1 (27.0)	0.9 (6.2)	-1.8 (10.0)	-2.9 (7.1)
Week 16	0.4 (7.7)	0.0 (6.3)	-2.3 (11.6)	-2.8 (8.4)
Week 20	4.1 (24.1)	1.0 (11.5)	-0.7 (13.8)	-3.8 (8.1)
Week 24	0.6 (11.8)	1.6 (10.4)	-1.8 (11.5)	-3.8 (8.4)
Week 28	0.0 (12.3)	0.0 (10.2)	-1.5 (11.1)	-3.4 (9.1)
Week 32	-0.3 (11.0)	0.3 (6.8)	-0.7 (12.9)	-3.4 (9.2)
Week 40	-0.6 (10.2)	0.1 (9.1)	-0.3 (11.5)	-1.5 (9.8)
Week 48	1.1 (10.8)	0.1 (13.1)	1.4 (13.4)	-2.1 (8.6)

37. Secondary Outcome

Title	Mean Change From Baseline in Alanine Aminotransferase
Description	Alanine Aminotransferase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	2.4 (14.1)	2.6 (10.6)	0.5 (11.1)	-0.1 (8.6)
Week 4	0.8 (9.9)	-0.5 (8.5)	0.9 (7.4)	0.3 (8.2)
Week 8	0.2 (10.2)	-0.8 (8.3)	5.3 (28.8)	-0.6 (9.6)
Week 12	7.0 (21.3)	0.8 (14.3)	-0.8 (8.1)	-0.1 (7.6)
Week 16	1.5 (13.3)	-0.4 (9.3)	0.0 (10.3)	-1.1 (7.8)
Week 20	5.3 (23.6)	-0.2 (10.2)	1.4 (10.8)	-3.7 (6.3)
Week 24	3.1 (20.9)	0.5 (14.1)	2.0 (12.0)	-2.8 (7.7)
Week 28	1.0 (13.9)	0.7 (10.5)	-0.4 (9.3)	-2.7 (7.2)
Week 32	1.2 (13.4)	-0.5 (10.3)	1.3 (10.8)	-3.2 (6.1)
Week 40	-0.5 (13.4)	2.6 (12.8)	3.0 (12.9)	-0.7 (8.3)
Week 48	0.4 (11.5)	-1.2 (10.4)	3.5 (17.0)	-1.1 (7.8)

38. Secondary Outcome

Title	Mean Change From Baseline in Alkaline Phosphatase
Description	Alkaline Phosphatase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	1.8 (10.7)	2.4 (10.6)	1.5 (8.0)	-3.6 (10.1)
Week 4	-1.7 (9.7)	0.7 (9.2)	-0.7 (8.4)	-4.7 (9.4)
Week 8	1.7 (12.9)	2.4 (12.7)	1.8 (15.6)	-6.1 (11.0)
Week 12	2.2 (11.6)	4.2 (16.4)	1.9 (12.9)	-4.4 (11.8)
Week 16	3.1 (10.7)	2.7 (13.0)	0.0 (10.4)	-6.7 (12.8)
Week 20	3.9 (14.0)	1.4 (11.8)	1.4 (11.8)	-7.4 (11.2)
Week 24	4.7 (15.0)	3.7 (14.0)	2.8 (11.6)	-2.7 (14.0)
Week 28	2.8 (14.0)	3.1 (14.2)	1.9 (9.5)	-2.1 (13.5)
Week 32	3.8 (14.6)	2.7 (16.0)	3.2 (12.1)	1.0 (15.9)
Week 40	2.4 (17.1)	1.3 (13.1)	2.7 (13.0)	-3.0 (18.0)
Week 48	2.6 (13.3)	4.0 (16.8)	5.5 (12.8)	-4.5 (18.8)

39. Secondary Outcome

Title	Mean Change From Baseline in Gamma Glutamyl Transferase
Description	Gamma Glutamyl Transferase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.3 (7.6)	2.0 (11.5)	8.8 (68.9)	-3.4 (24.3)
Week 4	2.1 (8.7)	-1.3 (8.8)	2.7 (28.5)	-6.5 (35.5)
Week 8	3.5 (23.0)	0.3 (10.5)	-2.8 (49.3)	-9.2 (43.3)
Week 12	4.1 (21.0)	0.5 (13.4)	-5.1 (29.3)	-8.3 (46.1)
Week 16	6.5 (20.2)	2.1 (12.5)	-6.1 (45.0)	-10.6 (47.7)
Week 20	3.5 (14.1)	0.2 (13.4)	-3.7 (50.3)	-8.5 (50.5)
Week 24	7.1 (22.0)	4.0 (18.7)	-0.4 (53.1)	-9.5 (47.2)
Week 28	4.6 (25.7)	2.2 (18.3)	-7.0 (46.8)	0.0 (23.1)
Week 32	4.4 (28.6)	1.5 (16.7)	-5.9 (44.5)	-8.2 (37.4)
Week 40	3.4 (41.3)	5.7 (32.4)	0.4 (10.1)	-9.1 (45.3)
Week 48	1.8 (11.4)	5.3 (23.9)	4.7 (21.6)	-9.8 (44.5)

40. Secondary Outcome

Title	Mean Change From Baseline in Bilirubin
Description	Bilirubin was measured in micromols per liter (µmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.35 (2.72)	-0.48 (2.71)	0.28 (2.38)	-0.78 (3.13)
Week 4	0.07 (2.50)	-0.18 (2.09)	-0.05 (2.14)	-0.79 (2.80)
Week 8	-0.09 (2.66)	-0.69 (2.22)	-0.19 (2.13)	-0.23 (2.80)
Week 12	-0.04 (2.60)	-0.70 (2.74)	0.37 (2.17)	-0.33 (3.28)
Week 16	0.06 (2.41)	-0.45 (2.43)	-0.20 (2.71)	-0.51 (3.64)
Week 20	-0.54 (2.89)	-0.38 (2.51)	0.51 (2.81)	-0.30 (3.03)
Week 24	0.08 (2.75)	-0.14 (2.86)	0.54 (2.18)	-0.38 (3.57)
Week 28	-0.10 (2.98)	-0.26 (3.23)	0.79 (2.71)	-0.82 (2.61)
Week 32	0.09 (2.75)	-0.38 (2.61)	0.93 (3.18)	-0.38 (3.61)
Week 40	-0.26 (3.70)	0.07 (3.18)	1.03 (2.35)	-0.15 (2.64)
Week 48	0.69 (3.57)	-0.50 (3.12)	0.79 (3.04)	-0.20 (2.52)

41. Secondary Outcome

Title	Mean Change From Baseline in Direct Bilirubin
Description	Direct Bilirubin was measured in micromols per liter (µmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.03 (0.92)	-0.06 (0.92)	0.09 (1.12)	-0.24 (1.10)
Week 4	0.10 (1.03)	0.03 (0.75)	-0.04 (0.82)	-0.10 (0.93)
Week 8	0.03 (0.91)	-0.18 (0.55)	-0.17 (0.86)	0.03 (1.10)
Week 12	0.15 (0.99)	-0.07 (0.95)	-0.01 (1.06)	-0.05 (1.30)
Week 16	0.18 (0.81)	-0.01 (0.66)	-0.07 (1.04)	-0.01 (1.40)
Week 20	-0.04 (0.95)	0.07 (0.91)	0.02 (0.94)	0.00 (1.19)
Week 24	0.05 (1.10)	0.14 (0.95)	0.08 (1.02)	-0.08 (1.25)
Week 28	0.06 (1.06)	-0.06 (1.00)	0.11 (0.80)	-0.06 (1.15)
Week 32	0.12 (1.16)	0.05 (0.90)	0.21 (1.21)	-0.04 (1.36)
Week 40	0.07 (1.31)	0.03 (0.76)	0.23 (1.00)	0.07 (1.05)
Week 48	0.31 (1.34)	-0.05 (1.01)	0.20 (1.25)	0.08 (0.98)

42. Secondary Outcome

Title	Mean Change From Baseline in Lactate Dehydrogenase
Description	Lactate Dehydrogenase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-3.3 (27.8)	-7.8 (21.2)	-5.9 (35.2)	-12.8 (24.8)
Week 4	-3.0 (23.4)	-3.7 (37.0)	-5.6 (35.6)	-18.5 (34.1)
Week 8	-5.7 (27.4)	-11.8 (31.5)	-9.2 (39.0)	-20.4 (37.4)
Week 12	3.0 (28.7)	-7.4 (34.6)	-11.1 (45.1)	-24.4 (39.0)
Week 16	-2.2 (25.5)	-11.1 (29.9)	-10.6 (48.6)	-22.4 (43.3)
Week 20	-0.7 (33.9)	-10.8 (37.0)	-9.9 (47.8)	-28.5 (32.1)
Week 24	-4.5 (31.3)	-14.3 (31.5)	-14.6 (34.4)	-29.3 (32.2)
Week 28	0.0 (40.8)	-16.0 (40.9)	-13.2 (35.0)	-34.8 (36.9)
Week 32	5.0 (55.0)	-9.9 (43.4)	-8.1 (33.5)	-22.9 (40.6)
Week 40	-1.6 (38.1)	-2.9 (41.1)	-8.0 (28.4)	-20.5 (40.1)
Week 48	-8.8 (35.2)	-4.2 (54.3)	-1.5 (32.7)	-16.0 (36.3)

43. Secondary Outcome

Title	Mean Change From Baseline in Creatinine
Description	Creatinine was measured in micromols per liter (µmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.9 (9.1)	-0.1 (8.0)	1.5 (5.8)	0.6 (7.2)
Week 4	-0.8 (8.9)	-0.2 (9.3)	-0.6 (7.3)	-1.4 (8.2)
Week 8	0.5 (7.0)	0.3 (7.6)	-0.5 (6.9)	0.1 (8.4)
Week 12	-0.3 (7.0)	1.4 (7.5)	-0.4 (6.4)	-0.7 (8.2)
Week 16	-0.1 (9.8)	1.0 (8.2)	0.7 (6.8)	-1.1 (9.4)
Week 20	0.7 (8.6)	1.4 (10.2)	0.8 (6.9)	-0.3 (7.7)
Week 24	0.0 (8.8)	0.8 (8.8)	0.3 (6.6)	0.9 (9.7)
Week 28	2.5 (10.0)	2.7 (10.0)	1.0 (7.8)	-0.9 (7.8)
Week 32	5.5 (35.7)	0.5 (8.1)	3.6 (7.8)	1.6 (11.2)
Week 40	2.3 (9.5)	2.2 (8.5)	3.9 (6.0)	3.0 (8.4)
Week 48	1.9 (10.6)	0.7 (7.6)	2.5 (5.2)	2.9 (9.8)

44. Secondary Outcome

Title	Mean Change From Baseline in Urea Nitrogen
Description	Urea Nitrogen was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.28 (1.55)	-0.09 (1.23)	-0.05 (1.32)	-0.02 (1.31)
Week 4	-0.07 (1.21)	-0.33 (1.52)	-0.14 (1.20)	0.04 (1.19)
Week 8	0.06 (1.25)	-0.26 (1.22)	-0.19 (1.07)	0.17 (1.59)
Week 12	0.03 (1.13)	-0.39 (1.31)	-0.29 (1.17)	-0.22 (1.15)
Week 16	0.19 (1.35)	-0.18 (1.40)	0.19 (1.49)	-0.03 (1.41)
Week 20	-0.18 (1.29)	-0.20 (1.33)	-0.25 (1.22)	-0.16 (1.08)
Week 24	0.08 (1.69)	-0.44 (1.38)	-0.13 (1.18)	-0.09 (1.50)
Week 28	0.13 (1.38)	0.03 (1.61)	-0.23 (1.26)	-0.22 (1.14)
Week 32	0.40 (2.37)	-0.30 (1.65)	0.21 (1.17)	0.10 (1.43)
Week 40	0.29 (1.54)	0.10 (1.73)	0.21 (1.20)	0.14 (1.43)
Week 48	0.05 (1.22)	-0.31 (1.54)	0.23 (1.38)	-0.02 (1.56)

45. Secondary Outcome

Title	Mean Change From Baseline in Sodium
Description	Sodium was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.1 (1.9)	-0.4 (2.4)	0.1 (1.6)	0.0 (2.2)
Week 4	-0.3 (2.0)	-0.6 (2.1)	0.3 (2.1)	-0.1 (2.4)
Week 8	0.1 (2.2)	-0.4 (2.4)	0.3 (2.2)	0.1 (2.3)
Week 12	-0.3 (2.0)	-0.5 (2.0)	0.2 (2.0)	0.1 (2.3)
Week 16	-0.4 (2.3)	-0.2 (1.9)	0.0 (2.0)	-0.2 (2.3)
Week 20	0.3 (2.2)	-0.8 (2.2)	-0.1 (2.0)	-0.5 (2.4)
Week 24	-0.1 (2.5)	-0.4 (2.2)	0.0 (2.2)	-0.3 (2.1)
Week 28	0.0 (1.9)	-0.4 (2.4)	0.2 (1.9)	0.1 (2.3)
Week 32	0.0 (2.3)	-0.8 (3.2)	0.1 (2.1)	0.2 (2.2)
Week 40	-0.1 (2.2)	-1.2 (2.2)	-0.1 (1.6)	-0.3 (2.4)
Week 48	-0.4 (2.0)	-1.1 (2.6)	-0.5 (1.7)	0.2 (2.3)

46. Secondary Outcome

Title	Mean Change From Baseline in Potassium
Description	Potassium was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.04 (0.45)	0.15 (0.40)	0.00 (0.36)	-0.03 (0.37)
Week 4	0.06 (0.44)	0.08 (0.35)	-0.07 (0.41)	-0.12 (0.40)
Week 8	-0.04 (0.40)	0.11 (0.38)	0.00 (0.35)	-0.07 (0.40)
Week 12	-0.01 (0.33)	0.02 (0.31)	-0.07 (0.41)	-0.12 (0.34)
Week 16	-0.01 (0.34)	0.16 (0.33)	-0.09 (0.42)	-0.05 (0.33)
Week 20	0.04 (0.38)	0.14 (0.33)	-0.04 (0.46)	-0.08 (0.37)
Week 24	0.06 (0.43)	0.07 (0.39)	0.03 (0.33)	-0.11 (0.37)
Week 28	0.09 (0.43)	0.12 (0.47)	0.06 (0.42)	0.03 (0.45)
Week 32	0.03 (0.44)	0.07 (0.44)	0.10 (0.46)	-0.05 (0.38)
Week 40	0.06 (0.33)	0.16 (0.51)	0.16 (0.39)	-0.06 (0.37)
Week 48	-0.01 (0.30)	0.00 (0.30)	-0.02 (0.39)	-0.07 (0.40)

47. Secondary Outcome

Title	Mean Change From Baseline in Calcium
Description	Calcium was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.008 (0.104)	-0.001 (0.103)	0.004 (0.088)	-0.008 (0.092)
Week 4	0.007 (0.108)	-0.018 (0.099)	-0.018 (0.090)	-0.001 (0.086)
Week 8	-0.006 (0.093)	-0.033 (0.117)	-0.014 (0.106)	-0.003 (0.089)
Week 12	0.006 (0.108)	-0.011 (0.121)	-0.013 (0.097)	-0.004 (0.111)
Week 16	-0.025 (0.106)	-0.004 (0.088)	-0.013 (0.095)	-0.024 (0.119)
Week 20	-0.036 (0.116)	-0.020 (0.084)	-0.015 (0.108)	0.005 (0.080)
Week 24	-0.027 (0.106)	-0.026 (0.094)	-0.012 (0.095)	0.007 (0.100)
Week 28	-0.031 (0.121)	-0.039 (0.091)	-0.016 (0.113)	-0.014 (0.092)
Week 32	0.003 (0.098)	-0.043 (0.099)	0.019 (0.107)	-0.001 (0.105)
Week 40	-0.027 (0.114)	-0.022 (0.115)	0.006 (0.115)	-0.012 (0.105)
Week 48	-0.013 (0.096)	-0.037 (0.119)	-0.004 (0.104)	-0.017 (0.110)

48. Secondary Outcome

Title	Mean Change From Baseline in Phosphate
Description	Phosphate was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.044 (0.163)	0.032 (0.192)	-0.047 (0.230)	0.033 (0.168)
Week 4	-0.004 (0.162)	-0.029 (0.185)	-0.070 (0.187)	0.020 (0.163)
Week 8	0.006 (0.178)	-0.063 (0.225)	-0.028 (0.207)	0.051 (0.187)
Week 12	0.029 (0.159)	-0.004 (0.149)	-0.015 (0.236)	0.045 (0.183)
Week 16	-0.010 (0.186)	0.012 (0.182)	-0.025 (0.195)	0.005 (0.178)
Week 20	-0.030 (0.208)	-0.037 (0.244)	-0.031 (0.177)	0.013 (0.187)
Week 24	-0.013 (0.181)	-0.042 (0.160)	-0.040 (0.229)	0.035 (0.200)
Week 28	-0.024 (0.189)	0.008 (0.238)	-0.031 (0.232)	0.037 (0.184)
Week 32	-0.002 (0.217)	-0.056 (0.223)	0.015 (0.220)	0.030 (0.190)
Week 40	0.018 (0.207)	0.009 (0.196)	-0.022 (0.208)	0.034 (0.224)
Week 48	0.032 (0.183)	-0.012 (0.167)	-0.044 (0.214)	0.035 (0.190)

49. Secondary Outcome

Title	Mean Change From Baseline in Cholesterol
Description	Cholesterol was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.00 (0.49)	-0.07 (0.46)	-0.06 (0.51)	-0.19 (0.47)
Week 4	-0.08 (0.49)	-0.03 (0.46)	-0.07 (0.68)	-0.07 (0.57)
Week 8	-0.09 (0.57)	-0.07 (0.46)	-0.15 (0.81)	-0.17 (0.59)
Week 12	-0.14 (0.72)	-0.16 (0.61)	-0.23 (0.68)	-0.10 (0.75)
Week 16	-0.16 (0.80)	-0.16 (0.66)	-0.35 (0.80)	-0.27 (0.72)
Week 20	-0.27 (0.77)	-0.22 (0.60)	-0.42 (0.81)	-0.23 (0.85)
Week 24	-0.12 (0.87)	-0.17 (0.66)	-0.28 (0.96)	-0.16 (0.78)
Week 28	-0.17 (0.89)	-0.37 (0.63)	-0.35 (0.97)	-0.29 (0.80)
Week 32	-0.13 (0.86)	-0.22 (0.63)	-0.16 (0.83)	-0.15 (0.81)
Week 40	-0.34 (0.87)	-0.25 (0.80)	-0.19 (0.77)	-0.13 (1.15)
Week 48	-0.40 (0.80)	-0.36 (0.74)	-0.23 (0.97)	-0.18 (1.09)

50. Secondary Outcome

Title	Mean Change From Baseline in Triglycerides
Description	Triglycerides was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.176 (1.593)	0.046 (0.683)	0.110 (0.855)	0.183 (0.751)
Week 4	-0.189 (1.212)	-0.004 (0.510)	-0.030 (0.471)	0.084 (0.529)
Week 8	-0.182 (1.554)	0.076 (0.582)	-0.084 (0.498)	0.046 (0.585)
Week 12	-0.265 (1.445)	0.088 (0.713)	0.063 (0.578)	0.009 (0.514)
Week 16	-0.164 (1.345)	0.099 (1.488)	0.142 (0.580)	0.112 (1.035)
Week 20	-0.233 (1.391)	-0.104 (0.837)	0.008 (0.622)	-0.060 (0.707)
Week 24	-0.263 (1.515)	-0.045 (0.774)	-0.013 (0.608)	-0.030 (0.707)
Week 28	-0.013 (1.559)	-0.125 (0.782)	-0.043 (0.423)	-0.036 (0.663)
Week 32	-0.260 (1.418)	0.045 (0.717)	0.057 (0.532)	0.112 (0.718)
Week 40	-0.134 (1.175)	-0.159 (0.765)	0.177 (0.821)	0.022 (0.644)
Week 48	-0.242 (1.516)	-0.149 (0.758)	0.114 (0.507)	0.054 (0.752)

51. Secondary Outcome

Title	Mean Change From Baseline in Protein
Description	Protein was measured in grams per liter (g/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.2 (3.7)	-1.2 (4.0)	-1.0 (4.2)	-1.1 (3.8)
Week 4	-1.5 (4.4)	-1.6 (4.2)	-1.5 (4.7)	-1.7 (4.4)
Week 8	-1.1 (4.4)	-2.1 (4.1)	-1.8 (5.7)	-2.0 (3.9)
Week 12	-0.8 (3.8)	-1.3 (4.7)	-1.4 (5.2)	-1.2 (5.8)
Week 16	-1.2 (5.2)	-0.3 (4.1)	-2.3 (5.6)	-3.8 (5.0)
Week 20	-2.7 (6.0)	-1.6 (4.6)	-2.6 (4.7)	-3.1 (5.4)
Week 24	-2.2 (7.5)	-1.8 (4.6)	-1.8 (5.5)	-2.0 (4.7)
Week 28	-3.1 (7.4)	-2.4 (4.6)	-2.5 (5.7)	-3.6 (6.4)
Week 32	-1.4 (6.9)	-1.5 (5.7)	-0.8 (5.0)	-1.9 (6.4)
Week 40	-2.2 (6.5)	-0.9 (5.0)	-1.8 (5.3)	-2.6 (6.1)
Week 48	-2.3 (6.2)	-2.4 (5.9)	-0.9 (5.1)	-3.4 (6.4)

52. Secondary Outcome

Title	Mean Change From Baseline in Albumin
Description	Albumin was measured in grams per liter (g/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.1 (2.1)	-0.4 (2.4)	-0.5 (2.4)	-0.5 (1.9)
Week 4	-0.5 (2.4)	-0.4 (2.3)	-0.2 (2.4)	-0.3 (1.9)
Week 8	-0.3 (2.3)	-0.3 (2.5)	-0.3 (3.0)	0.1 (2.2)
Week 12	-0.1 (2.2)	0.2 (2.7)	0.2 (2.7)	0.7 (3.0)
Week 16	0.0 (2.5)	1.0 (2.5)	0.1 (2.9)	-0.2 (2.9)
Week 20	-0.7 (2.7)	0.1 (2.7)	0.4 (2.4)	0.4 (2.2)
Week 24	-0.1 (2.9)	0.0 (2.1)	0.4 (2.4)	1.2 (2.7)
Week 28	-0.7 (3.0)	-0.4 (2.3)	0.1 (2.9)	0.1 (2.6)
Week 32	0.6 (2.8)	-0.1 (3.0)	0.9 (3.2)	0.7 (2.8)
Week 40	0.1 (2.8)	-0.1 (2.9)	0.2 (2.6)	0.3 (3.0)
Week 48	0.1 (2.8)	-0.7 (3.0)	0.2 (3.0)	-0.8 (3.5)

53. Secondary Outcome

Title	Mean Change From Baseline in Glucose
Description	Glucose was measured in millimoles per liter (mmol/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	0.18 (0.75)	0.26 (0.70)	0.09 (0.78)	0.13 (1.28)
Week 4	0.04 (0.71)	0.03 (0.70)	-0.04 (0.90)	0.11 (1.10)
Week 8	0.17 (0.66)	0.12 (0.90)	0.23 (0.95)	0.12 (1.16)
Week 12	-0.08 (0.69)	0.08 (0.66)	-0.13 (0.79)	-0.15 (0.99)
Week 16	0.11 (0.77)	0.06 (0.63)	0.16 (0.92)	-0.18 (1.47)
Week 20	0.16 (0.85)	0.20 (0.84)	0.13 (0.83)	-0.08 (1.01)
Week 24	-0.07 (0.85)	0.05 (0.49)	-0.09 (0.73)	-0.22 (1.06)
Week 28	0.22 (1.01)	0.09 (0.76)	-0.01 (0.74)	0.07 (1.22)
Week 32	-0.04 (0.72)	-0.07 (0.63)	-0.08 (0.65)	0.06 (1.10)
Week 40	-0.05 (0.62)	0.08 (0.71)	-0.09 (0.68)	-0.08 (1.07)
Week 48	-0.14 (0.78)	-0.11 (0.61)	-0.06 (0.64)	-0.14 (1.25)

54. Secondary Outcome

Title	Mean Change From Baseline in Lipase, Pancreatic
Description	Lipase, Pancreatic was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-1.1 (10.5)	2.2 (11.9)	0.1 (9.2)	-0.2 (7.5)
Week 4	-2.1 (9.8)	0.9 (9.1)	0.1 (10.6)	-1.2 (10.0)
Week 8	-3.1 (9.2)	3.7 (11.8)	2.0 (20.0)	-1.8 (10.3)
Week 12	-0.5 (8.7)	1.0 (11.1)	-0.7 (13.4)	-0.6 (9.6)
Week 16	0.4 (7.4)	2.7 (8.4)	0.5 (11.3)	-0.2 (11.8)
Week 20	-0.6 (10.4)	2.1 (8.0)	-0.9 (9.0)	-1.7 (9.3)
Week 24	-0.5 (11.0)	-0.1 (9.1)	-0.1 (8.1)	1.2 (11.8)
Week 28	1.6 (13.1)	1.7 (10.5)	0.5 (11.9)	1.7 (14.1)
Week 32	1.1 (15.1)	1.0 (11.0)	1.2 (10.6)	3.8 (21.6)
Week 40	1.2 (11.0)	1.3 (7.0)	-0.3 (8.9)	2.5 (8.9)
Week 48	1.4 (10.1)	2.2 (10.0)	0.3 (10.7)	3.7 (10.2)

55. Secondary Outcome

Title	Mean Change From Baseline in Creatine Kinase
Description	Creatine Kinase was measured in units per liter (U/L).
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-3.0 (67.1)	-2.2 (55.6)	-2.2 (18.2)	0.1 (46.5)
Week 4	29.6 (218.4)	-6.2 (54.8)	3.2 (22.0)	-16.9 (56.5)
Week 8	-4.9 (56.9)	-8.5 (52.7)	-1.5 (23.6)	-4.6 (122.1)
Week 12	-6.3 (57.5)	-8.4 (85.8)	-3.0 (22.4)	-29.4 (80.7)
Week 16	0.9 (59.4)	-11.5 (105.1)	-7.5 (22.2)	-23.2 (106.3)
Week 20	-8.2 (60.0)	5.9 (149.1)	-3.5 (22.2)	-33.4 (95.3)
Week 24	-6.4 (48.6)	-5.4 (123.7)	-2.6 (27.4)	-27.7 (98.9)
Week 28	-1.5 (67.3)	-19.1 (131.5)	-0.7 (25.4)	-36.7 (103.8)
Week 32	2.0 (67.0)	-10.0 (167.0)	34.0 (222.1)	-24.2 (91.2)
Week 40	9.9 (109.1)	-20.4 (131.4)	-2.7 (25.4)	-16.3 (106.4)
Week 48	7.8 (67.3)	-20.4 (138.3)	-3.6 (25.5)	-33.4 (106.5)

56. Secondary Outcome

Title	Mean Change From Baseline in pH
Description
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.01 (0.66)	0.03 (0.62)	-0.07 (0.67)	0.15 (0.78)
Week 4	0.10 (0.77)	0.15 (0.52)	0.06 (0.72)	0.16 (0.74)
Week 8	-0.12 (0.79)	0.00 (0.62)	-0.08 (0.56)	-0.04 (0.65)
Week 12	0.00 (0.81)	0.15 (0.69)	0.03 (0.79)	0.20 (0.83)
Week 16	-0.02 (0.61)	0.00 (0.51)	-0.09 (0.81)	0.11 (0.69)
Week 20	-0.11 (0.75)	-0.01 (0.59)	0.06 (0.58)	0.07 (0.88)
Week 24	0.03 (0.85)	-0.01 (0.46)	-0.11 (0.81)	0.02 (0.81)
Week 28	-0.13 (0.84)	-0.06 (0.57)	-0.05 (0.73)	-0.01 (0.69)
Week 32	-0.02 (0.75)	-0.03 (0.55)	-0.18 (0.66)	0.09 (0.86)
Week 40	-0.14 (0.81)	0.19 (0.66)	-0.21 (0.81)	-0.07 (0.62)
Week 48	-0.11 (0.66)	0.06 (0.73)	-0.11 (0.74)	-0.08 (0.72)

57. Secondary Outcome

Title	Mean Change From Baseline in Erythrocytes (/HPF)
Description
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-6.8 (53.7)	0.1 (8.4)	0.2 (2.4)	0.9 (7.9)
Week 4	-8.7 (52.6)	-0.8 (4.1)	1.4 (10.5)	-0.6 (3.2)
Week 8	-8.7 (53.5)	-0.3 (6.9)	0.4 (6.1)	0.0 (6.8)
Week 12	-8.6 (52.6)	1.3 (17.4)	-0.4 (2.4)	17.4 (118.5)
Week 16	-5.7 (48.0)	-1.3 (4.1)	-0.6 (2.6)	-0.5 (5.5)
Week 20	-7.7 (53.7)	-1.0 (3.5)	-0.1 (3.9)	-0.6 (4.4)
Week 24	-7.2 (53.5)	-1.2 (3.9)	-0.3 (2.3)	-0.9 (4.6)
Week 28	-7.6 (51.3)	-1.3 (4.2)	-0.7 (2.9)	3.0 (16.9)
Week 32	-8.5 (52.5)	4.9 (41.8)	0.0 (3.9)	0.1 (4.5)
Week 40	-9.1 (53.2)	3.5 (18.8)	-0.5 (3.5)	0.4 (5.4)
Week 48	-9.7 (56.3)	-0.4 (5.4)	1.9 (15.5)	0.1 (4.0)

58. Secondary Outcome

Title	Mean Change From Baseline in Leukocytes (/HPF)
Description
Time Frame	From Baseline (Week 1) to Week 48

Outcome Measure Data

Analysis Population Description
The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

Arm/Group Title	SOC + Placebo iv Q4W (SS)	SOC + DZP 6mg/kg iv Q4W (SS)	SOC + DZP 24mg/kg iv Q4W (SS)	SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
Measure Participants	45	45	45	47
Week 2	-0.1 (11.4)	-1.4 (8.1)	-0.8 (2.9)	2.9 (13.7)
Week 4	-0.2 (9.0)	-0.6 (8.5)	-0.7 (4.5)	3.0 (12.6)
Week 8	-1.2 (10.4)	4.8 (29.3)	-0.3 (6.8)	3.0 (14.4)
Week 12	-1.1 (11.3)	4.4 (42.2)	-1.3 (4.2)	2.7 (13.9)
Week 16	0.1 (9.6)	-1.6 (12.5)	-0.2 (9.6)	1.8 (12.9)
Week 20	-0.1 (10.1)	3.7 (13.3)	0.4 (9.8)	1.7 (4.0)
Week 24	-1.0 (10.9)	10.7 (52.1)	-0.7 (4.5)	0.4 (4.5)
Week 28	-0.2 (9.6)	2.4 (9.7)	-1.1 (4.4)	2.0 (10.1)
Week 32	-0.6 (10.8)	-0.5 (13.5)	-1.0 (5.4)	4.1 (15.7)
Week 40	-1.6 (10.4)	2.2 (19.8)	1.4 (7.7)	6.8 (30.9)
Week 48	-0.3 (8.9)	10.8 (71.9)	-1.0 (4.0)	0.8 (5.3)

Adverse Events

	SOC + Placebo iv Q4W (SS)		SOC + DZP 6mg/kg iv Q4W (SS)		SOC + DZP 24mg/kg iv Q4W (SS)		SOC + DZP 45mg/kg iv Q4W (SS)
Time Frame	Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
Adverse Event Reporting Description

Arm/Group Title	SOC + Placebo iv Q4W (SS)		SOC + DZP 6mg/kg iv Q4W (SS)		SOC + DZP 24mg/kg iv Q4W (SS)		SOC + DZP 45mg/kg iv Q4W (SS)
Arm/Group Description	This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.		This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)		0/45 (0%)		0/47 (0%)
Serious Adverse Events
	SOC + Placebo iv Q4W (SS)		SOC + DZP 6mg/kg iv Q4W (SS)		SOC + DZP 24mg/kg iv Q4W (SS)		SOC + DZP 45mg/kg iv Q4W (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/45 (13.3%)		5/45 (11.1%)		6/45 (13.3%)		5/47 (10.6%)
Blood and lymphatic system disorders
Anaemia	0/45 (0%)	0	0/45 (0%)	0	1/45 (2.2%)	1	0/47 (0%)	0
Autoimmune haemolytic anaemia	0/45 (0%)	0	1/45 (2.2%)	1	0/45 (0%)	0	0/47 (0%)	0
Haemorrhagic disorder	1/45 (2.2%)	1	0/45 (0%)	0	0/45 (0%)	0	0/47 (0%)	0
Antiphospholipid syndrome	1/45 (2.2%)	1	0/45 (0%)	0	0/45 (0%)	0	0/47 (0%)	0
Cardiac disorders
Coronary artery disease	0/45 (0%)	0	0/45 (0%)	0	1/45 (2.2%)	1	0/47 (0%)	0
Gastrointestinal disorders
Anastomotic ulcer perforation	0/45 (0%)	0	0/45 (0%)	0	0/45 (0%)	0	1/47 (2.1%)	1
Infections and infestations
Cellulitis	1/45 (2.2%)	2	0/45 (0%)	0	1/45 (2.2%)	2	0/47 (0%)	0
Herpes zoster	1/45 (2.2%)	1	1/45 (2.2%)	1	0/45 (0%)	0	0/47 (0%)	0
Influenza	1/45 (2.2%)	1	0/45 (0%)	0	0/45 (0%)	0	0/47 (0%)	0
Pseudomonal bacteraemia	0/45 (0%)	0	0/45 (0%)	0	1/45 (2.2%)	1	0/47 (0%)	0
Urinary tract infection	0/45 (0%)	0	0/45 (0%)	0	0/45 (0%)	0	1/47 (2.1%)	1
Appendicitis	0/45 (0%)	0	0/45 (0%)	0	1/45 (2.2%)	1	0/47 (0%)	0
Pyelonephritis	0/45 (0%)	0	0/45 (0%)	0	0/45 (0%)	0	1/47 (2.1%)	1
Injury, poisoning and procedural complications
Thoracic vertebral fracture	0/45 (0%)	0	1/45 (2.2%)	1	0/45 (0%)	0	0/47 (0%)	0
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus	2/45 (4.4%)	3	0/45 (0%)	0	0/45 (0%)	0	1/47 (2.1%)	2
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/45 (0%)	0	1/45 (2.2%)	1	0/45 (0%)	0	0/47 (0%)	0
Renal and urinary disorders
Lupus nephritis	0/45 (0%)	0	1/45 (2.2%)	1	0/45 (0%)	0	1/47 (2.1%)	1
Nephrosclerosis	0/45 (0%)	0	1/45 (2.2%)	1	0/45 (0%)	0	0/47 (0%)	0
Renal tubular necrosis	0/45 (0%)	0	1/45 (2.2%)	1	0/45 (0%)	0	0/47 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumothorax	0/45 (0%)	0	0/45 (0%)	0	1/45 (2.2%)	1	0/47 (0%)	0
Pulmonary embolism	1/45 (2.2%)	1	0/45 (0%)	0	0/45 (0%)	0	0/47 (0%)	0
Vascular disorders
Deep vein thrombosis	1/45 (2.2%)	1	0/45 (0%)	0	0/45 (0%)	0	0/47 (0%)	0
Other (Not Including Serious) Adverse Events
	SOC + Placebo iv Q4W (SS)		SOC + DZP 6mg/kg iv Q4W (SS)		SOC + DZP 24mg/kg iv Q4W (SS)		SOC + DZP 45mg/kg iv Q4W (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/45 (42.2%)		23/45 (51.1%)		22/45 (48.9%)		21/47 (44.7%)
Gastrointestinal disorders
Diarrhoea	2/45 (4.4%)	2	4/45 (8.9%)	4	3/45 (6.7%)	3	3/47 (6.4%)	3
Nausea	2/45 (4.4%)	2	1/45 (2.2%)	1	3/45 (6.7%)	3	1/47 (2.1%)	1
Dyspepsia	5/45 (11.1%)	5	1/45 (2.2%)	2	0/45 (0%)	0	0/47 (0%)	0
Infections and infestations
Nasopharyngitis	2/45 (4.4%)	2	5/45 (11.1%)	5	5/45 (11.1%)	6	4/47 (8.5%)	4
Upper respiratory tract infection	4/45 (8.9%)	5	4/45 (8.9%)	4	3/45 (6.7%)	3	5/47 (10.6%)	6
Pharyngitis	1/45 (2.2%)	1	4/45 (8.9%)	4	4/45 (8.9%)	6	3/47 (6.4%)	4
Urinary tract infection	2/45 (4.4%)	3	4/45 (8.9%)	4	2/45 (4.4%)	2	2/47 (4.3%)	2
Bronchitis	0/45 (0%)	0	3/45 (6.7%)	5	1/45 (2.2%)	1	2/47 (4.3%)	2
Investigations
Hepatic enzyme increased	3/45 (6.7%)	3	0/45 (0%)	0	0/45 (0%)	0	0/47 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	2/45 (4.4%)	2	4/45 (8.9%)	4	0/45 (0%)	0	2/47 (4.3%)	2
Nervous system disorders
Headache	5/45 (11.1%)	5	5/45 (11.1%)	13	4/45 (8.9%)	4	2/47 (4.3%)	2
Migraine	0/45 (0%)	0	0/45 (0%)	0	0/45 (0%)	0	3/47 (6.4%)	3
Psychiatric disorders
Anxiety	1/45 (2.2%)	1	1/45 (2.2%)	1	3/45 (6.7%)	3	0/47 (0%)	0
Vascular disorders
Hypertension	1/45 (2.2%)	1	3/45 (6.7%)	3	3/45 (6.7%)	4	2/47 (4.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	UCB
Organization	Cares
Phone	+1844 599 ext 2273
Email	UCBCares@ucb.com

Responsible Party:

UCB Biopharma S.P.R.L.

ClinicalTrials.gov Identifier:

NCT02804763

Other Study ID Numbers:

SL0023
2015-004457-40

First Posted:

Jun 17, 2016

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021