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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 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Litifilimab
Study Locations (20)
Florida
- Arthritis & Rheumatic Disease Specialties — Aventura
- Highlands Rheumatology — Avon Park
- Clinical Research of West Florida - Corporate — Clearwater
- Believe Clinical Trials — Coral Springs
- Omega Research Consultants — DeBary
- Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale
- GNP Research at Mark Jaffe, MD — Hollywood
- Life Clinical Trials — Margate
- Charisma Medical and Research Center — Miami Lakes
- Rheumatology Associates of Central Florida — Orlando
California
- Wallace Rheumatic Study Center — Beverly Hills
- University of Southern California — Los Angeles
- Providence Facey Medical Foundation — Mission Hills
- University of California San Diego School of Medicine — San Diego
- SCLA Management — Thousand Oaks
- Harbor-UCLA Medical Center — Torrance
- Inland Rheumatology Clinical Trials, Inc. — Upland
Alabama
- Tilda Research Birmingham — Homewood
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
District of Columbia
- Georgetown University Hospital-Medstar — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 548 participants |
| Start Date | 2021-05-25 |
| Est. Completion | 2027-03-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04895241
The ClinicalTrials.gov registry entry for NCT04895241 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 548 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04895241 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04895241 about?
NCT04895241 is a clinical study titled "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". 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, stero...
What is the current status of trial NCT04895241?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 548 participants. The study started on 2021-05-25. Estimated completion is 2027-03-16.
What conditions does trial NCT04895241 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04895241?
The interventions under investigation include: Placebo (DRUG), Litifilimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04895241?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04895241 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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