Status:
RECRUITING
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Lead Sponsor:
Biogen
Conditions:
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 eithe...
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 ...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
- Must have active cutaneous manifestations that meet study criteria.
- Must have a CLASI-A score ≥10.
- Must have an active CLE lesion despite an adequate trial of antimalarial treatment.
- Key
Exclusion
- Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
- 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.
- Active severe lupus nephritis.
- Active neuropsychiatric SLE.
- Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
- 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
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05531565
Start Date
September 13 2022
End Date
December 14 2027
Last Update
March 12 2026
Active Locations (305)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
UAB Center for Women's Reproductive Health
Birmingham, Alabama, United States, 35233-7340
3
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States, 85032
4
The Regents of the University of California
La Jolla, California, United States, 92037