A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Purpose
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). The main questions researchers want to answer are: - How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? - How many participants have their skin disease activity go down by at least 70% as measured by CLASI? Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: - After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine. - Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. - The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin. - During the 2nd treatment period, all participants will receive litifilimab for 28 weeks. - After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks. - The total study duration for participants will be up to 80 weeks.
Conditions
- Subacute Cutaneous Lupus Erythematosus
- Chronic Cutaneous Lupus Erythematosus
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations. 2. Must have active cutaneous manifestations that meet study criteria. 3. Must have a CLASI-A score ≥10. 4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.
Exclusion Criteria
- Any active skin conditions other than CLE that may interfere with the study assessments of CLE. 2. Diagnosis of mixed connective tissue disease [(within 1 year of signing the informed consent form (ICF)] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year. 3. Active severe lupus nephritis. 4. Active neuropsychiatric SLE. 5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study. 6. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to screening, have not been at a stable and allowable dose. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A (Phase 2): Litifilimab |
Participants will receive litifilimab subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive litifilimab during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26. |
|
|
Placebo Comparator Part A (Phase 2): Placebo |
Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26. |
|
|
Experimental Part B (Phase 3): Litifilimab |
Participants will receive litifilimab SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26. |
|
|
Placebo Comparator Part B (Phase 3): Placebo |
Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26. |
|
Recruiting Locations
Anniston, Alabama 36207
256-236-0055
Birmingham, Alabama 35233-7340
205-502-9960
Phoenix, Arizona 85032
480-443-8400
La Jolla, California 92037
858-246-2382
Los Angeles, California 90045
310-337-7171
Upland, California 91786
909-296-8700
DeBary, Florida 32713
407-988-1075
Miami, Florida 33125
305-542-3535
Miami, Florida 33126
800-377-2235
Miami, Florida 33175
305-582-7752
Plantation, Florida 33317
713-487-8680
Bowling Green, Kentucky 42104
844-378-9633
New Orleans, Louisiana 70112
318-675-5930
Boston, Massachusetts 02111
617-636-0156
Boston, Massachusetts 02115
617-732-6378
Quincy, Massachusetts 02169
781-253-7165
Ann Arbor, Michigan 48103
734-712-3376
Auburn Hills, Michigan 48326
248-858-2255
Troy, Michigan 48084
248-590-0298
St Louis, Missouri 63110
314-256-3454
Brooklyn, New York 11220
929-455-2399
Fairport, New York 14450
585-275-7546
Great Neck, New York 11021
516-708-2557
New York, New York 10032
212-305-4308
Chapel Hill, North Carolina 27514
919-843-6619
Durham, North Carolina 27710
919-385-7546
Cincinnati, Ohio 45219
513-475-7631
Philadelphia, Pennsylvania 19104
215-615-2940
Nashville, Tennessee 37232
615-936-4072
Austin, Texas 78731
512-344-0362
Colleyville, Texas 76034
972-299-8399
Dallas, Texas 75390-8896
214-645-2400
Frisco, Texas 75034
888-635-0552
Galveston, Texas 77555-0583
409-772-5047
Waco, Texas 76710
254-755-4584
Salt Lake City, Utah 84132
801-581-2955
Blacksburg, Virginia 24060
540-476-8966
San Juan, Puerto Rico 917
7879362100
More Details
- NCT ID
- NCT05531565
- Status
- Recruiting
- Sponsor
- Biogen
Detailed Description
Litifilimab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting blood dendritic cell antigen 2. It is an inhibitory receptor expressed on the surface of human plasmacytoid dendritic cell (pDCs) and is being investigated for the potential treatment of systemic lupus erythematosus and cutaneous lupus erythematosus. The primary objectives of the study are to evaluate the efficacy of litifilimab compared with placebo in reducing skin disease activity measured by the CLA-IGA-R score [Parts A] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of litifilimab in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of litifilimab in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of litifilimab [Parts A and B].