Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
Completed · Phase 2 · Has a placebo group
Conditions studied: Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus
In brief
The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) 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).
Key facts
- Study ID
- NCT02847598
- Run by
- Biogen
- People needed
- 264
- Starts
- 2016-10-20
- Expected to finish
- 2019-11-18
- Last updated by the study team
- 2023-11-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Arthritis & Rheumatology — Phoenix, Arizona, United States
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- TriWest Research Associates, LLC — El Cajon, California, United States
- Tien Q Nguyen MD Inc — Fountain Valley, California, United States
- MD Med Corp — Hemet, California, United States
- Universtiy of California, Irvine — Irvine, California, United States
- The Regents of the University of California — La Jolla, California, United States
- Purushotham Akther & Rosan Kotha, MD Inc. — La Mesa, California, United States
- Dermatology Reserach Associates — Los Angeles, California, United States
- University Clinical Trials — San Diego, California, United States
- Richard Barthel, MD — Santa Barbara, California, United States
- Robin K. Dore, MD, Inc. — Tustin, California, United States
- Inland Rheumatology Clinical Trials Inc. — Upland, California, United States
- Nazanin Firooz, MD Inc. — West Hills, California, United States
- Denver Arthritis Clinic — Denver, Colorado, United States
- Medical Faculty Associates, Inc. — Washington D.C., District of Columbia, United States
- Howard University Hospital — Washington D.C., District of Columbia, United States
- Washington DC VA Medical Center — Washington D.C., District of Columbia, United States
- Clinical Research of West Florida- Corporate — Clearwater, Florida, United States
- Medical Research Center Of Miami — Miami, Florida, United States
- Lakes Research, LLC — Miami Lakes, Florida, United States
- Omega Research Consultants — Orlando, Florida, United States
- Compass Research, LLC — Orlando, Florida, United States
- DMI Research, Inc. — Pinellas Park, Florida, United States
- Pinnacle Research Group LLC — Anniston, Alabama, United States
Full record on ClinicalTrials.gov
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