A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (NCT04895241)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
🩺 Plain-English Summary (8th-Grade Level)
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: \- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. 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 SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. * All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. * Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.
Who can join: Review the eligibility criteria below.
Location: Tilda Research Birmingham — Homewood, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (164 Sites)
Showing the first 25 of 164 sites.
- Tilda Research Birmingham — Homewood, Alabama
- Wallace Rheumatic Study Center — Beverly Hills, California
- University of Southern California — Los Angeles, California
- Providence Facey Medical Foundation — Mission Hills, California
- University of California San Diego School of Medicine — San Diego, California
- SCLA Management — Thousand Oaks, California
- Harbor-UCLA Medical Center — Torrance, California
- Inland Rheumatology Clinical Trials, Inc. — Upland, California
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- Georgetown University Hospital-Medstar — Washington D.C., District of Columbia
- Arthritis & Rheumatic Disease Specialties — Aventura, Florida
- Highlands Rheumatology — Avon Park, Florida
- Clinical Research of West Florida - Corporate — Clearwater, Florida
- Believe Clinical Trials — Coral Springs, Florida
- Omega Research Consultants — DeBary, Florida
- Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida
- GNP Research at Mark Jaffe, MD — Hollywood, Florida
- Life Clinical Trials — Margate, Florida
- Charisma Medical and Research Center — Miami Lakes, Florida
- Rheumatology Associates of Central Florida — Orlando, Florida
- AdventHealth Medical Group — Tampa, Florida
- Vantage Clinical Trials — Tampa, Florida
- Rheumatology care of Georgia — Kennesaw, Georgia
- Atlanta Research Center for Rheumatology LLC — Marietta, Georgia
- Accurate Clinical Research Inc. — Lake Charles, Louisiana
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lupus Erythematosus, Systemic
- A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE) — Phoenix, Arizona
- Interactive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus — Denver, Colorado
- Engagement in CHildhood-Onset Systemic Lupus — The Bronx, New York
- A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus — Huntington Park, California
- A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus — Tucson, Arizona
Explore by condition: All Lupus Erythematosus, Systemic clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.