LILAC: Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT02847598

Collaborator

(none)

264

Enrollment

129

Locations

Arms

36.9

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of the study is to evaluate the efficacy of BIIB059 in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus Active Cutaneous Lupus Erythematosus	Drug: BIIB059 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

264 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

Actual Study Start Date :

Oct 20, 2016

Actual Primary Completion Date :

Aug 28, 2019

Actual Study Completion Date :

Nov 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: BIIB059 450 mg BIIB059 450 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional dose at Week 2 for a total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with systemic lupus erythematosus [SLE] with active skin manifestations and joint involvement.	Drug: BIIB059 Administered as specified in the treatment arm.
Placebo Comparator: Part A: Placebo BIIB059 matching placebo administered subcutaneously (SC) every 4 weeks (Q4W) with an additional dose at Week 2 for a total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with [SLE] with active skin manifestations and joint involvement.	Drug: Placebo Administered as specified in the treatment arm.
Experimental: Part B: BIIB059 50 mg BIIB059 50 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active cutaneous lupus erythematosus [CLE] with or without systemic manifestations.	Drug: BIIB059 Administered as specified in the treatment arm.
Experimental: Part B: BIIB059 150 mg BIIB059 150 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active [CLE] with or without systemic manifestations.	Drug: BIIB059 Administered as specified in the treatment arm.
Experimental: Part B: BIIB059 450 mg BIIB059 450 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active [CLE] with or without systemic manifestations.	Drug: BIIB059 Administered as specified in the treatment arm.
Placebo Comparator: Part B: Placebo BIIB059 matching placebo administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active [CLE] with or without systemic manifestations.	Drug: Placebo Administered as specified in the treatment arm.

Outcome Measures

Primary Outcome Measures

Part A: Change from Baseline in Active Joint Count (28-joint Assessment) to Week 24 [Baseline, Week 24]
An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
Part B: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 [Baseline, Week 16]
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.

Secondary Outcome Measures

Percentage of Participants with CLASI-50 Response at Week 24 (Part A) and Weeks 12 and 16 (Part B) [Baseline up to Week 24]
CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24 (Part A) and Weeks 12 and 16 (Part B). The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
Percent Change from Baseline in CLASI-A Score to Weeks 12, 16, and 24 (Part A) and Week 12 (Part B) [Baseline up to Week 24]
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
Percentage of Participants with a ≥ 4-point reduction in CLASI-A score Relative to Baseline at Weeks 12 and 16 (Part B), and Week 24 (Part A) [Baseline up to Week 24]
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
Percentage of Participants with a Composite Response (Part A) [Baseline, Week 24]
Composite response is defined as: Participants with a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) of ≥4 (SRI-4) at Week 24. SRI-4 is defined as a reduction from baseline of ≥4 points in SLE Disease Activity Index 2000 (SLEDAI-2K). Participants will also have no new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. No worsening from baseline in the participant's lupus disease activity is to be present, defined by <0.3 point increase in Physician's Global Assessment (PGA) visual analogue scale (VAS). Lastly, the participants will have no protocol-prohibited medication or treatment, concomitant corticosteroid dosage at Week 24 is <=10 mg/day, concomitant corticosteroid dosage at Week 24 is <=Day 1 corticosteroid dosage, and there is to be no increase in corticosteroid dose between Weeks 17 and 24.
Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score to Week 24 (Part A) [Baseline, Week 24]
The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
Percentage of Participants with no New Organ System Affected (Part A) [Baseline, Week 24]
No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B.
Change from baseline in Physician's Global Assessment (PGA) visual analog scale (VAS) score (Part A) [Baseline, Week 24]
BIIB059 Clearance [Up to Week 36]
BIIB059 Volume of Distribution [Up to Week 36]
BIIB059 Absorption Rate [Up to Week 36]
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 36 weeks]
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
Number of Participants with Clinically Significant Laboratory Assessment Abnormalities [Up to Week 36]
Number of Participants with Clinically Significant Vital Sign Abnormalities [Up to Week 36]
Number of Participants with Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities [Up to Week 36]
Number of Participants with Positive Serum BIIB059 Antibodies [Up to Week 36]
Absolute Change From Baseline Over Time in Immunoglobulin Levels [Up to Week 36]
Absolute Change From Baseline Over Time in Vaccine Titers [Up to Week 36]
Percent Change From Baseline Over Time in Immunoglobulin Levels [Up to Week 36]
Percent Change From Baseline Over Time in Vaccine Titers [Up to Week 36]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Part A:

Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the 1997 revised American College of Rheumatology (ACR) classification criteria for SLE along with active skin manifestations and joint involvement.
At least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints and/or wrist.
Demonstrate at least one sign of active lupus skin disease, including acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus (DLE)), with skin activity defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at the time of Screening and randomization.

Part B:

Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has been histologically confirmed (in the past or at Screening), with or without SLE manifestations.

Key Exclusion Criteria:

Active lupus nephritis or moderate-to-severe or chronic kidney disease.
Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
History of chronic, recurrent (3 or more of the same type of infection in a 12-month period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as determined by the Investigator and requiring anti-infective treatment within 12 weeks prior to Screening.
Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were initiated less than 12 weeks prior to Randomization.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnacle Research Group LLC	Anniston	Alabama	United States	36207
2	Arizona Arthritis & Rheumatology	Phoenix	Arizona	United States	85037
3	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
4	TriWest Research Associates, LLC	El Cajon	California	United States	92020
5	Tien Q Nguyen MD Inc	Fountain Valley	California	United States	92708
6	MD Med Corp	Hemet	California	United States	92543
7	Universtiy of California, Irvine	Irvine	California	United States	92697
8	The Regents of the University of California	La Jolla	California	United States	92037
9	Purushotham Akther & Rosan Kotha, MD Inc.	La Mesa	California	United States	92120
10	Dermatology Reserach Associates	Los Angeles	California	United States	90045
11	University Clinical Trials	San Diego	California	United States	92123
12	Richard Barthel, MD	Santa Barbara	California	United States	93108
13	Robin K. Dore, MD, Inc.	Tustin	California	United States	92780
14	Inland Rheumatology Clinical Trials Inc.	Upland	California	United States	91786
15	Nazanin Firooz, MD Inc.	West Hills	California	United States	91307
16	Denver Arthritis Clinic	Denver	Colorado	United States	80230
17	Medical Faculty Associates, Inc.	Washington	District of Columbia	United States	20037
18	Howard University Hospital	Washington	District of Columbia	United States	20060
19	Washington DC VA Medical Center	Washington	District of Columbia	United States	20422
20	Clinical Research of West Florida- Corporate	Clearwater	Florida	United States	33765
21	Lakes Research, LLC	Miami Lakes	Florida	United States	33014
22	Medical Research Center Of Miami	Miami	Florida	United States	33144
23	Omega Research Consultants	Orlando	Florida	United States	32804
24	Compass Research, LLC	Orlando	Florida	United States	32806
25	DMI Research, Inc.	Pinellas Park	Florida	United States	33710
26	Advanced Medical Reserarch, PC	Sandy Springs	Georgia	United States	30328
27	Advanced Clinical Research	Boise	Idaho	United States	83642
28	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46256
29	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
30	University of Michigan	Ann Arbor	Michigan	United States	48109
31	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
32	Davis Group, LTD	Las Vegas	Nevada	United States	89128
33	Valley Hospital	Ridgewood	New Jersey	United States	07450
34	Institute for Rheumatic & Autoimmune diseases, Overlook Medical Center	Summit	New Jersey	United States	07901
35	Albuquerque Center For Rheumatology	Albuquerque	New Mexico	United States	87102
36	North Shore/Long Island Jewish PRIME	Great Neck	New York	United States	11020
37	Univeristy of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
38	Joint and Muscle Research Institute	Charlotte	North Carolina	United States	28204
39	American Health Research, Inc.	Charlotte	North Carolina	United States	28207
40	Medication Management, LLC	Greensboro	North Carolina	United States	27408
41	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
42	Ohio State University Clinical Trials	Columbus	Ohio	United States	43215
43	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
44	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania	United States	15213
45	UPMC Arthritis Center	Pittsburgh	Pennsylvania	United States	15213
46	Medical University of South Carolina	Charleston	South Carolina	United States	29425
47	Low Country Rheumatology, PA	North Charleston	South Carolina	United States	29406
48	University of Tennessee Health Sciences Center	Memphis	Tennessee	United States	38104
49	Austin Regional Clinic, P.A.	Austin	Texas	United States	78731
50	UT Southwestern Medical Center	Dallas	Texas	United States	75390
51	Accurate Clinical Research, Inc.	Houston	Texas	United States	77034
52	Pioneer Research Solutions, Inc.	Houston	Texas	United States	77099
53	Virginia Clinical Research	Norfolk	Virginia	United States	23507
54	Research Site	Quilmes	Buenos Aires	Argentina	B1878GEG
55	Research Site	Bueno Aires	Ciudad Autonoma Bueno Aires	Argentina	C1015ABO
56	Research Site	Bueno Aires	Ciudad Autonoma Bueno Aires	Argentina	C1046AAQ
57	Research Site	San Miguel de Tucuman	Tucuman	Argentina	T4000AXL
58	Research Site	San Miguel de Tucuman	Tucuman	Argentina	T4000BRD
59	Research Site	Ciudad Autonoma Buenos Aires		Argentina	C1056ABJ
60	Research Site	Ciudad Autonoma Buenos Aires		Argentina	C1221ADC
61	Research Site	Ciudad Autonoma Buenos Aires		Argentina	C1425AGC
62	Research Site	Ciudad Autonoma Buenos Aires		Argentina	C1425DKG
63	Research Site	Ciudad Autonoma Buenos Aires		Argentina	C1431FWO
64	Research Site	Cordoba		Argentina	5004
65	Research Site	Mendoza		Argentina	5500
66	Research Site	San Juan		Argentina	5400
67	Research Site	Pleven		Bulgaria	5800
68	Research Site	Plovdiv		Bulgaria	4000
69	Research Site	Plovdiv		Bulgaria	4002
70	Research Site	Ruse		Bulgaria	7000
71	Research Site	Ruse		Bulgaria	7002
72	Research Site	Shumen		Bulgaria	9700
73	Research Site	Sofia		Bulgaria	1407
74	Research Site	Sofia		Bulgaria	1431
75	Research Site	Sofia		Bulgaria	1463
76	Research Site	Sofia		Bulgaria	1606
77	Research Site	Barranquilla		Colombia	080020
78	Research Site	Barranquilla		Colombia	80020
79	Research Site	Bogota		Colombia	110221
80	Research Site	Bogota		Colombia	111211
81	Research Site	Bucaramanga		Colombia	680003
82	Research Site	Medellín		Colombia	050034
83	Research Site	Jerusalem		Israel	9112001
84	Research Site	Ramat Gan		Israel	5265601
85	Research Site	Suwon-Si	Gyeonggi-do	Korea, Republic of	443-380
86	Research Site	Daejeon		Korea, Republic of	35233
87	Research Site	Saltillo	Coahuila	Mexico	25000
88	Research Site	Mexico	Distrito Federal	Mexico	03100
89	Research Site	Mexico	Distrito Federal	Mexico	06700
90	Research Site	Mexico	Distrito Federal	Mexico	14080
91	Research Site	Guadalajara	Jalisco	Mexico	44130
92	Research Site	Guadalajara	Jalisco	Mexico	44690
93	Research Site	Morelia	Michoacán	Mexico	58260
94	Research Site	Cuernavaca	Morelos	Mexico	62290
95	Research Site	Monterrey	Neuvo Leon	Mexico	64000
96	Research Site	San Luis Potosi	San Luis Potos	Mexico	78213
97	Research Site	San Luis Potosi	San Luis Potos	Mexico	78240
98	Research Site	Merida	Yucatan	Mexico	97070
99	Research Site	Durango		Mexico	34270
100	Research Site	Angeles City	Pampanga	Philippines	2009
101	Research Site	Batangas		Philippines	4127
102	Research Site	Cebu City		Philippines	6000
103	Research Site	Dasmarinas		Philippines	4114
104	Research Site	Davao City		Philippines	8000
105	Research Site	Iloilo City		Philippines	5000
106	Research Site	Iloilo		Philippines	5000
107	Research Site	Makati City		Philippines	1229
108	Research Site	Manila		Philippines	1000
109	Research Site	Manila		Philippines	1008
110	Research Site	Quezon City		Philippines	1102
111	Research Site	Bydgoszcz		Poland	85-168
112	Research Site	Krakow		Poland	30-033
113	Research Site	Krakow		Poland	30-363
114	Research Site	Lodz		Poland	90-436
115	Research Site	Olsztyn		Poland	10-117
116	Research Site	Poznan		Poland	60-529
117	Research Site	Wroclaw		Poland	50-368
118	Research Site	Belgrade		Serbia	11000
119	Research Site	Niska Banja		Serbia	18205
120	Research Site	Sabac		Serbia	15000
121	Research Site	Changhua		Taiwan	50004
122	Research Site	Kaohsiung		Taiwan	824
123	Research Site	Taipei		Taiwan	100
124	Research Site	Taoyuan		Taiwan	333
125	Research Site	Pathum Thani	Klongluang	Thailand	12120
126	Research Site	Chiang Mai	Muang	Thailand	50200
127	Research Site	Khon Kaen	Muang	Thailand	40002
128	Research Site	Bangkok	Pathumwan	Thailand	10330
129	Research Site	Hat Yai	Songkhla	Thailand	90110

Sponsors and Collaborators

Biogen

Investigators

Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Biogen

ClinicalTrials.gov Identifier:

NCT02847598

Other Study ID Numbers:

230LE201
2015-004359-32

First Posted:

Jul 28, 2016

Last Update Posted:

Sep 2, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Biogen

CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Lupus

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

Lupus Erythematosus, Cutaneous

Study Results

No Results Posted as of Sep 2, 2020