A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT02962960
Collaborator
(none)
36
14
4
22
2.6
0.1
Study Details
Study Description
Brief Summary
This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.
Actual Study Start Date
:
Feb 14, 2017
Actual Primary Completion Date
:
Jan 22, 2018
Actual Study Completion Date
:
Dec 17, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Anifrolumab - Lower dose 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 |
Drug: Anifrolumab
subcutaneous administration every 2 weeks from week 0 to week 50
|
| Placebo Comparator: Placebo matching for lower dose of Anifrolumab 1ml, once every second week, one subcutaneous injection added to stand of care, from week 0 to week 50 |
Drug: Placebo
subcutaneous administration every two weeks from week 0 to week 50
|
| Experimental: Anifrolumab - Higher dose 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 |
Drug: Anifrolumab
subcutaneous administration every 2 weeks from week 0 to week 50
|
| Placebo Comparator: Placebo matching for higher dose of Anifrolumab 2×1ml , once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 |
Drug: Placebo
subcutaneous administration every two weeks from week 0 to week 50
|
Outcome Measures
Primary Outcome Measures
- Maximum Concentration of Anifrolumab in Serum After First Dose [Week 0]
Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.
- Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab [Week 12]
Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).
- 21-gene Type 1 IFN Signature Score (Fold-change) [Week 12]
21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.
- 21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change) [Week 12]
21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)*100) for the 21 genes. At a population level, the results are presented as mean the above.
Secondary Outcome Measures
- Number of Participants With Antidrug Antibody (ADA) [Baseline to Week 52]
Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA)
- Number of Participants With Neutralizing Antibodies (nAb) [Baseline to Week 52]
Incidence of detectable nAb in post-baseline ADA positive participants.
- Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) [Baseline to Week 52]
Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.
- Change From Baseline for Vital Signs [Baseline to Week 60]
Change from baseline for vital signs.
- Change From Baseline for Physical Examination [Baseline to Week 60]
Physical examination is reported as change from baseline in body weight.
- Change From Baseline for 12-lead ECG [Baseline to Week 52]
The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant [NCS]), abnormal (clinically significant [CS]), or not done.
- Value of Haemoglobin Blood Test to Detect Change From Baseline [Baseline to Week 60]
Change from baseline in haemoglobin blood tests are reported.
- Value of Haematology Blood Tests to Detect Change From Baseline [Baseline to Week 60]
Change from baseline in haematology blood tests (leucocytes [particle concentration], platelets [particle concentration]) are reported.
- Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline [Baseline to Week 60]
Change from baseline in protein-creatinine ratio urinalysis tests are reported.
- Value of Total Protein Urinalysis Test to Detect Change From Baseline [Baseline to Week 60]
Change from baseline in total protein urinalysis tests are reported.
- Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) [Baseline to Week 60]
Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase) are reported.
- Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) [Baseline to Week 60]
Change from baseline in clinical creatinine chemistry blood tests (serum) are reported.
- Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline [Baseline to Week 60]
Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported.
- Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline [Baseline to Week 60]
Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported.
- Number of Participants With Positive Hepatitis B Core Antibody Post-baseline. [Baseline to Week 60]
Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age 18 through 70 years
-
Diagnosis of paediatric or adult SLE for > 24 weeks and fulfilling ≥4 of the 11 American College of Rheumatology (ACR) classification criteria with at least one being:
-
Positive antinuclear antibody (ANA) or
-
Elevated anti-dsDNA antibodies or
-
anti-Smith (anti-Sm) antibodies
-
Interferon high test result
-
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10
-
Currently receiving at least 1 of the following for treatment of SLE:
• Oral prednisone or equivalent of ≤40 mg/day for a minimum of 2 weeks prior to signing the Informed Consent Form (ICF) and with stable dose for at least 2 weeks prior to randomization
• Any of the following medications for at least 12 weeks prior to signing the ICF, and at a stable doses for at least 8 weeks prior to randomization: (i) Azathioprine ≤200 mg/day (ii) Antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25 mg/week (v) Mizoribine ≤150 mg/day
-
Must not have signs of active or latent tuberculosis (TB).
-
Must not be pregnant or breastfeeding.
Exclusion Criteria:
-
Active severe or unstable neuropsychiatric SLE
-
Active severe SLE-driven renal disease
-
Any severe herpes infection at any time
-
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or HIV infection.
-
Known history of a primary immunodeficiency (splenectomy, or any underlying condition predisposing for infection
-
Receipt of any investigation product within 4 weeks or 5 half -lives prior to signing of the ICF
-
History of cancer, apart from:
-
Squamous or basal cell carcinoma of the skin if successfully treated.
-
Cervical cancer in situ if successfully treated
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Thousand Oaks | California | United States | 91360 |
| 2 | Research Site | Orlando | Florida | United States | 32810 |
| 3 | Research Site | New York | New York | United States | 10019 |
| 4 | Research Site | Charlotte | North Carolina | United States | 28204 |
| 5 | Research Site | Memphis | Tennessee | United States | 38119 |
| 6 | Research Site | Houston | Texas | United States | 77034 |
| 7 | Research Site | Debrecen | Hungary | 4032 | |
| 8 | Research Site | Zalaegerszeg | Hungary | 8900 | |
| 9 | Research Site | Anyang-si | Korea, Republic of | 14068 | |
| 10 | Research Site | Busan | Korea, Republic of | 49241 | |
| 11 | Research Site | Daegu | Korea, Republic of | 41944 | |
| 12 | Research Site | Gwangju | Korea, Republic of | 61469 | |
| 13 | Research Site | Bydgoszcz | Poland | 85-168 | |
| 14 | Research Site | Warszawa | Poland | 00-874 |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02962960
Other Study ID Numbers:
- D3461C00008
First Posted:
Nov 15, 2016
Last Update Posted:
Dec 18, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants type I Interferon (IFN) test-high Systemic Lupus Erythematosus (SLE) subjects with active skin manifestations while receiving Standard of Care (SOC) treatment were eligible for the study. |
|---|---|
| Pre-assignment Detail | 36 patients were randomized, and all received at least one dose of study treatment. |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator |
|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
| Period Title: Overall Study | |||
| STARTED | 14 | 13 | 9 |
| COMPLETED | 11 | 11 | 9 |
| NOT COMPLETED | 3 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator | Total |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 | Total of all reporting groups |
| Overall Participants | 14 | 13 | 9 | 36 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
46.3
(9.1)
|
41.5
(9.2)
|
47.8
(14.2)
|
44.9
(10.6)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
12
85.7%
|
12
92.3%
|
8
88.9%
|
32
88.9%
|
| Male |
2
14.3%
|
1
7.7%
|
1
11.1%
|
4
11.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
14
100%
|
13
100%
|
9
100%
|
36
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
6
42.9%
|
2
15.4%
|
0
0%
|
8
22.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
8
57.1%
|
11
84.6%
|
9
100%
|
28
77.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Maximum Concentration of Anifrolumab in Serum After First Dose |
|---|---|
| Description | Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment. |
| Time Frame | Week 0 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose. |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose |
|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 |
| Measure Participants | 13 | 13 |
| Geometric Mean (Geometric Coefficient of Variation) [mcg/mL] |
14.058
(49.8151)
|
28.115
(74.4916)
|
| Title | Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab |
|---|---|
| Description | Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose). |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose. |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose |
|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 |
| Measure Participants | 11 | 11 |
| Geometric Mean (Geometric Coefficient of Variation) [mcg/mL] |
15.618
(81.3595)
|
16.926
(9205.6677)
|
| Title | 21-gene Type 1 IFN Signature Score (Fold-change) |
|---|---|
| Description | 21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who are 21-gene IFN test high at baseline. |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator |
|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
| Measure Participants | 11 | 11 | 9 |
| Mean (Standard Deviation) [fold change] |
3.2
(3.69)
|
3.5
(5.73)
|
14.3
(6.68)
|
| Title | 21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change) |
|---|---|
| Description | 21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)*100) for the 21 genes. At a population level, the results are presented as mean the above. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who are 21-gene IFN test high at baseline. |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator |
|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
| Measure Participants | 11 | 11 | 9 |
| Mean (Standard Deviation) [percentage neutralization] |
77.5
(24.16)
|
80.5
(36.65)
|
15.1
(49.63)
|
| Title | Number of Participants With Antidrug Antibody (ADA) |
|---|---|
| Description | Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA) |
| Time Frame | Baseline to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator |
|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 9 |
| Count of Participants [Participants] |
1
7.1%
|
1
7.7%
|
0
0%
|
| Title | Number of Participants With Neutralizing Antibodies (nAb) |
|---|---|
| Description | Incidence of detectable nAb in post-baseline ADA positive participants. |
| Time Frame | Baseline to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator |
|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
| Measure Participants | 1 | 1 | 0 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
| Title | Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) |
|---|---|
| Description | Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section. |
| Time Frame | Baseline to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator |
|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 9 |
| Any adverse event |
12
85.7%
|
11
84.6%
|
7
77.8%
|
| Any serious adverse event |
4
28.6%
|
2
15.4%
|
0
0%
|
| Any adverse event of special interest |
5
35.7%
|
1
7.7%
|
1
11.1%
|
| Title | Change From Baseline for Vital Signs |
|---|---|
| Description | Change from baseline for vital signs. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 5 | 4 |
| Systolic Blood Pressure (mmHg) - Week 12 |
-4.1
(12.08)
|
3
(6.63)
|
-5.8
(13.99)
|
7.3
(8.96)
|
| Systolic Blood Pressure (mmHg) - Week 52 |
2.1
(10.96)
|
-1.7
(12.96)
|
3.4
(8.53)
|
12.5
(19.36)
|
| Systolic Blood Pressure (mmHg) - Week 60 |
4.1
(19.70)
|
-2.8
(14.91)
|
12.2
(8.61)
|
4.5
(7.14)
|
| Diastolic Blood Pressure (mmHg) - Week 12 |
-2.0
(10.02)
|
2.4
(6.71)
|
-3.8
(6.50)
|
4.3
(4.35)
|
| Diastolic Blood Pressure (mmHg) - Week 52 |
0.1
(6.87)
|
2.9
(7.54)
|
-0.4
(7.13)
|
6.8
(5.38)
|
| Diastolic Blood Pressure (mmHg) - Week 60 |
3.6
(12.23)
|
-0.8
(6.86)
|
-1.0
(8.22)
|
8.8
(6.29)
|
| Title | Change From Baseline for Physical Examination |
|---|---|
| Description | Physical examination is reported as change from baseline in body weight. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 5 | 4 |
| Week 12 |
-1.81
(2.674)
|
1.37
(3.113)
|
0.7
(1.889)
|
0.98
(2.904)
|
| Week 52 |
-2.83
(4.683)
|
2.52
(6.495)
|
0.30
(3.338)
|
3.90
(5.608)
|
| Week 60 |
-1.81
(3.858)
|
2.93
(6.463)
|
1.06
(4.020)
|
3.60
(5.300)
|
| Title | Change From Baseline for 12-lead ECG |
|---|---|
| Description | The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant [NCS]), abnormal (clinically significant [CS]), or not done. |
| Time Frame | Baseline to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 5 | 4 |
| Normal baseline - Normal Week 52 |
7
50%
|
10
76.9%
|
5
55.6%
|
3
8.3%
|
| Normal baseline - Abnormal (NCS) Week 52 |
1
7.1%
|
1
7.7%
|
0
0%
|
0
0%
|
| Normal baseline - not done Week 52 |
1
7.1%
|
2
15.4%
|
0
0%
|
0
0%
|
| Abnormal (NCS) baseline - Normal Week 52 |
2
14.3%
|
0
0%
|
0
0%
|
1
2.8%
|
| Abnormal (NCS) baseline - Abnormal (NCS) Week 52 |
1
7.1%
|
0
0%
|
0
0%
|
0
0%
|
| Abnormal (NCS) baseline - not done Week 52 |
2
14.3%
|
0
0%
|
0
0%
|
0
0%
|
| Not done baseline - Normal Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not done baseline - Abnormal (NCS) Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not done baseline - Not done Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Normal baseline - Abnormal (CS) Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Abnormal (NCS) baseline - Abnormal (CS) Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not done baseline - Abnormal (CS) Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Abnormal (CS) baseline - Normal Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Abnormal (CS) baseline - Abnormal (CS) Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Abnormal (CS) baseline - Not done Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Abnormal (CS) baseline - Abnormal (NCS) Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Value of Haemoglobin Blood Test to Detect Change From Baseline |
|---|---|
| Description | Change from baseline in haemoglobin blood tests are reported. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 5 | 4 |
| Haemoglobin - Week 12 |
-0.2
(9.07)
|
0.7
(7.4)
|
-0.5
(7.14)
|
4.8
(5.91)
|
| Haemoglobin - Week 52 |
-1.1
(13.92)
|
0.1
(11.65)
|
-4.8
(3.83)
|
7
(5.94)
|
| Haemoglobin - Week 60 |
0.8
(12.97)
|
0
(10.43)
|
-5.4
(5.68)
|
5.8
(6.85)
|
| Title | Value of Haematology Blood Tests to Detect Change From Baseline |
|---|---|
| Description | Change from baseline in haematology blood tests (leucocytes [particle concentration], platelets [particle concentration]) are reported. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 5 | 4 |
| Leucocytes - Week 12 |
0.491
(1.5806)
|
3.165
(2.2706)
|
0.867
(1.0999)
|
1.96
(1.9487)
|
| Leucocytes - Week 52 |
1.041
(1.5794)
|
2.457
(2.3891)
|
0.236
(1.0107)
|
0.080
(1.4798)
|
| Leucocytes - Week 60 |
-0.012
(1.5489)
|
1.474
(1.6490)
|
0.776
(2.1779)
|
1.23
(1.6687)
|
| Platelets - Week 12 |
7.8
(65.28)
|
45.2
(67.41)
|
10.3
(24.54)
|
17.0
(42.58)
|
| Platelets - Week 52 |
28.0
(74.28)
|
46.1
(74.91)
|
6.6
(64.24)
|
-2.0
(33.85)
|
| Platelets - Week 60 |
-19.1
(53.48)
|
39.0
(60.33)
|
24.4
(65.73)
|
-2.8
(28.43)
|
| Title | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline |
|---|---|
| Description | Change from baseline in protein-creatinine ratio urinalysis tests are reported. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 5 | 4 |
| Protein/Creatinine - Week 12 |
1.37029
(5.186672)
|
-0.13007
(1.123807)
|
-0.03056
(0.056701)
|
0.32764
(0.337631)
|
| Protein/Creatinine - Week 52 |
0.03756
(0.135157)
|
-0.00465
(0.183327)
|
-0.00781
(0.047671)
|
0.080930
(1.581772)
|
| Protein/Creatinine - Week 60 |
0.02578
(0.119862)
|
-0.28836
(1.185347)
|
-0.03501
(0.061888)
|
0.46178
(0.899886)
|
| Title | Value of Total Protein Urinalysis Test to Detect Change From Baseline |
|---|---|
| Description | Change from baseline in total protein urinalysis tests are reported. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 5 | 4 |
| Protein, Total - Week 12 |
0.7669
(2.71221)
|
-0.0744
(0.76445)
|
0
(0)
|
0.3443
(0.34301)
|
| Protein, Total - Week 52 |
-0.0029
(0.08124)
|
-0.0011
(0.33468)
|
0
(0)
|
0.1143
(0.24476)
|
| Protein, Total - Week 60 |
0.1151
(0.12514)
|
-0.1790
(0.83066)
|
0.003
(0.00671)
|
0.3975
(0.82602)
|
| Title | Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) |
|---|---|
| Description | Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase) are reported. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 5 | 4 |
| Alanine Aminotransferase - Week 12 |
0.00769
(0.147479)
|
-0.13003
(0.431764)
|
-0.05418
(0.045905)
|
0.02501
(0.134397)
|
| Alanine Aminotransferase - Week 52 |
-0.06335
(0.119642)
|
-0.05607
(0.556152)
|
-0.06335
(0.047735)
|
0.04167
(0.169182)
|
| Alanine Aminotransferase - Week 60 |
-0.01297
(0.043131)
|
0.09446
(0.365981)
|
-0.04334
(0.032495)
|
-0.01667
(0.18127)
|
| Aspartate Aminotransferase - Week 12 |
-0.01154
(0.065765)
|
-0.10502
(0.169099)
|
0.00417
(0.059911)
|
0.03334
(0.105430)
|
| Aspartate Aminotransferase - Week 52 |
-0.04834
(0.066424)
|
-0.05304
(0.196369)
|
0.00333
(0.090847)
|
0.09169
(0.100482)
|
| Aspartate Aminotransferase - Week 60 |
-0.01111
(0.058937)
|
0.04816
(0.123752)
|
0
(0.050010)
|
-0.02501
(0.099555)
|
| Title | Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) |
|---|---|
| Description | Change from baseline in clinical creatinine chemistry blood tests (serum) are reported. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 5 | 4 |
| Creatinine - Week 12 |
4.385
(8.5799)
|
-3.6
(11.2467)
|
5.5
(6.3509)
|
5.25
(9.8446)
|
| Creatinine - Week 52 |
12.2
(33.2597)
|
-7.273
(19.5862)
|
0.2
(13.9714)
|
2.5
(5.5076)
|
| Creatinine - Week 60 |
7.316
(8.7449)
|
-5.556
(12.8463)
|
5.0
(10.4163)
|
6.5
(12.5033)
|
| Title | Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline |
|---|---|
| Description | Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator |
|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
| Measure Participants | 14 | 13 | 9 |
| ESR - Week 12 |
-3.0
(20.37)
|
-7.2
(15.46)
|
-11.9
(15.36)
|
| ESR - Week 52 |
5.6
(25.58)
|
-6.7
(12.25)
|
-16.0
(10.95)
|
| ESR - Week 60 |
14.6
(38.77)
|
-1.0
(21.84)
|
2.2
(22.48)
|
| Title | Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline |
|---|---|
| Description | Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). Only participants with abnormal baseline values are included in this analysis. |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 9 | 8 | 3 | 3 |
| anti-dsDNA - Week 12 |
-42.09
(256.228)
|
-84.97
(231.489)
|
-37.0
(19.799)
|
-97.33
(151.596)
|
| anti-dsDNA - Week 52 |
-99.04
(288.183)
|
8.70
(27.308)
|
-13.0
(50.229)
|
-76.87
(127.433)
|
| anti-dsDNA - Week 60 |
52.67
(144.220)
|
16.53
(30.528)
|
-21.33
(54.921)
|
-76.73
(141.525)
|
| Title | Number of Participants With Positive Hepatitis B Core Antibody Post-baseline. |
|---|---|
| Description | Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening. |
| Time Frame | Baseline to Week 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). No participants were positive for Hepatitis B at screening, therefore no participants were tested post-baseline. |
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator to Lower Dose | Placebo Comparator to Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
| Measure Participants | 0 | 0 | 0 | 0 |
| Positive |
Adverse Events
| Time Frame | 52 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied. | |||||
| Arm/Group Title | Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator | |||
| Arm/Group Description | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 | |||
All Cause Mortality |
||||||
| Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/13 (0%) | 0/9 (0%) | |||
Serious Adverse Events |
||||||
| Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/14 (28.6%) | 2/13 (15.4%) | 0/9 (0%) | |||
| Gastrointestinal disorders | ||||||
| Mouth Ulceration | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Infections and infestations | ||||||
| Herpes Zoster | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Otitis Media Acute | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Systemic Lupus Erythematosus | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Nervous system disorders | ||||||
| Transient Ischaemic Attack | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Lupus Nephritis | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Anifrolumab - Lower Dose | Anifrolumab - Higher Dose | Placebo Comparator | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/14 (85.7%) | 11/13 (84.6%) | 7/9 (77.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Cardiac disorders | ||||||
| Atrial Fibrillation | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Palpitations | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Pericardial Cyst | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Eye disorders | ||||||
| Chalazion | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Myopia | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Uveitis | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal Discomfort | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Abdominal Pain | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Dental Caries | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Diarrhoea | 2/14 (14.3%) | 2 | 0/13 (0%) | 0 | 2/9 (22.2%) | 2 |
| Food Poisoning | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Gastrooesophageal Reflux Disease | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Haemorrhoids | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Mouth Ulceration | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Nausea | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Paraesthesia Oral | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| General disorders | ||||||
| Chest Pain | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Face Oedema | 0/14 (0%) | 0 | 1/13 (7.7%) | 2 | 0/9 (0%) | 0 |
| Feeling Hot | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Oedema Peripheral | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Pain | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Pyrexia | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Immune system disorders | ||||||
| Hypersensitivity | 0/14 (0%) | 0 | 1/13 (7.7%) | 2 | 0/9 (0%) | 0 |
| Infections and infestations | ||||||
| Abscess Limb | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Acute Sinusitis | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Bronchitis | 1/14 (7.1%) | 1 | 3/13 (23.1%) | 5 | 1/9 (11.1%) | 1 |
| Conjunctivitis | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Conjunctivitis Viral | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Herpes Zoster | 2/14 (14.3%) | 2 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Influenza | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Labyrinthitis | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Laryngitis | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Nasopharyngitis | 3/14 (21.4%) | 3 | 2/13 (15.4%) | 2 | 1/9 (11.1%) | 1 |
| Pharyngitis | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 2 | 0/9 (0%) | 0 |
| Sinusitis | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Upper Respiratory Tract Infection | 5/14 (35.7%) | 9 | 1/13 (7.7%) | 1 | 3/9 (33.3%) | 3 |
| Urinary Tract Infection | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Foot Fracture | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Spinal Compression Fracture | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Subcutaneous Haematoma | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Investigations | ||||||
| Mycobacterium Tuberculosis Complex Test Positive | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back Pain | 2/14 (14.3%) | 2 | 1/13 (7.7%) | 1 | 1/9 (11.1%) | 1 |
| Osteoporosis | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
| Spinal Pain | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Nervous system disorders | ||||||
| Dizziness | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Headache | 2/14 (14.3%) | 2 | 2/13 (15.4%) | 2 | 0/9 (0%) | 0 |
| Hypoaesthesia | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Migraine | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Sciatica | 0/14 (0%) | 0 | 2/13 (15.4%) | 2 | 0/9 (0%) | 0 |
| Syncope | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||||
| Anembryonic Gestation | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Psychiatric disorders | ||||||
| Anxiety | 1/14 (7.1%) | 2 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Panic Attack | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Dysuria | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Proteinuria | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
| Renal Impairment | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| Endometrial Hyperplasia | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Epistaxis | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Nasal Inflammation | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Nasal Septum Perforation | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Pleural Effusion | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Productive Cough | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Rhinorrhoea | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Angioedema | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Miliaria | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Urticaria | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
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 | Global Clinical Lead |
|---|---|
| Organization | AstraZeneca AB |
| Phone | 301-398-5799 |
| ClinicalTrialTransparency@astrazeneca.com |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02962960
Other Study ID Numbers:
- D3461C00008
First Posted:
Nov 15, 2016
Last Update Posted:
Dec 18, 2019
Last Verified:
Dec 1, 2019