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
Public ClinicalTrials.gov record NCT04895241. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04895241
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 548 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 25, 2021 (Actual)
- Primary completion
- Sep 30, 2026 (Estimated)
- Completion
- Mar 16, 2027 (Estimated)
- Last update posted
- Feb 10, 2026
2021 – 2027
United States locations
- U.S. sites
- 53
- U.S. states
- 17
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tilda Research Birmingham | Homewood | Alabama | 35209 | — |
| Wallace Rheumatic Study Center | Beverly Hills | California | 90211 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Providence Facey Medical Foundation | Mission Hills | California | 91345 | — |
| University of California San Diego School of Medicine | San Diego | California | 92103 | — |
| SCLA Management | Thousand Oaks | California | 91360 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90509 | — |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Georgetown University Hospital-Medstar | Washington D.C. | District of Columbia | 20007-2113 | — |
| Arthritis & Rheumatic Disease Specialties | Aventura | Florida | 33180 | — |
| Highlands Rheumatology | Avon Park | Florida | 33825 | — |
| Clinical Research of West Florida - Corporate | Clearwater | Florida | 33765 | — |
| Believe Clinical Trials | Coral Springs | Florida | 33065 | — |
| Omega Research Consultants | DeBary | Florida | 32713 | — |
| Centre for Rheumatology, Immunology and Arthritis | Fort Lauderdale | Florida | 33334 | — |
| GNP Research at Mark Jaffe, MD | Hollywood | Florida | 33024 | — |
| Life Clinical Trials | Margate | Florida | 33063 | — |
| Charisma Medical and Research Center | Miami Lakes | Florida | 33014 | — |
| Rheumatology Associates of Central Florida | Orlando | Florida | 32806 | — |
| AdventHealth Medical Group | Tampa | Florida | 33613 | — |
| Vantage Clinical Trials | Tampa | Florida | 33614 | — |
| Rheumatology care of Georgia | Kennesaw | Georgia | 30144 | — |
| Atlanta Research Center for Rheumatology LLC | Marietta | Georgia | 30060 | — |
| Accurate Clinical Research Inc. | Lake Charles | Louisiana | 70605 | — |
| AA MRC LLC Ahmed Arif Medical Research Center | Flint | Michigan | 48504 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Renown Medical Group | Reno | Nevada | 89502 | — |
| Joseph S. and Diane H. Steinberg Ambulatory Care Center | Brooklyn | New York | 11201 | — |
| Northwell Health Center for Advanced Medicine | New Hyde Park | New York | 11042-1118 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | — |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204 | — |
| Medication Management, LLC | Greensboro | North Carolina | 27405 | — |
| OnSite Clinical Solutions, LLC - Charlotte | Salisbury | North Carolina | 28144 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | 44130 | — |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | — |
| Ramesh C Gupta, MD | Memphis | Tennessee | 38119 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| PrimeCare 360 | Allen | Texas | 75013 | — |
| Precision Comprehensive Clinical Research Solution | Colleyville | Texas | 76034-5913 | — |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | — |
| Arthritis Care Texas | Corpus Christi | Texas | 78415 | — |
| Prolato Clinical Research Center | Houston | Texas | 77054 | — |
| Accurate Clinical Management LLC | Houston | Texas | 77089 | — |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77099 | — |
| Accurate Clinical Research, Inc. | Humble | Texas | 77346 | — |
| Accurate Clinical Research | Stafford | Texas | 77477 | — |
| Fort Bend Rheumatology Associates | Sugar Land | Texas | 77407 | — |
| Advanced Rheumatology of Houston | The Woodlands | Texas | 77382 | — |
| CLS Research Ctr, PLLC | Webster | Texas | 77598 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 111 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04895241, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 10, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04895241 live on ClinicalTrials.gov.