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 NCT04961567. 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
- NCT04961567
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 562 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
- Jul 15, 2021
- Primary completion
- Sep 26, 2026
- Completion
- Mar 15, 2027
- Last update posted
- Jan 28, 2026
2021 – 2027
United States locations
- U.S. sites
- 44
- U.S. states
- 16
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Arizona Arthritis & Rheumatology Associates, P.C. | Glendale | Arizona | 85306 | — |
| Care Access Research - Huntington BeachCare Access Research - Huntington Beach | Huntington Beach | California | 92648 | — |
| Valerius Medical Group | Los Alamitos | California | 90720 | — |
| The Practice of Medicine | Los Angeles | California | 90004 | — |
| R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center | Monterey Park | California | 91754 | — |
| Neurovations | Napa | California | 94558 | — |
| Joo-Hyung Lee MD | Orange | California | 92868 | — |
| Medvin Clinical Research | Whittier | California | 90602 | — |
| RASF - Clinical Research Center | Boca Raton | Florida | 33486 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| Vida Clinical Research | Kissimmee | Florida | 34741 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| HMD Research, LLC | Orlando | Florida | 32819 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33606 | — |
| The Emory Clinic Emory University | Atlanta | Georgia | 30322 | — |
| Jefrey Lieberman, M.D., P.C. | Decatur | Georgia | 30033 | — |
| Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia | Gainesville | Georgia | 30501 | — |
| RNA America Health Sciences | Gainesville | Georgia | 30518 | — |
| EBGS Clinical Trials | Snellville | Georgia | 30078 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | — |
| DM Clinical Research - Boston | Brookline | Massachusetts | 02445 | — |
| University of Massachusetts | Worcester | Massachusetts | 01655 | — |
| Saint Louis Rheumatology | St Louis | Missouri | 63119 | — |
| Arthritis & Osteoporosis Associates, PA | Freehold | New Jersey | 07728 | — |
| Arthritis and Osteoporosis Associates of New Mexico | Las Cruces | New Mexico | 88011 | — |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28210 | — |
| Carolina Arthritis Associates | Wilmington | North Carolina | 28401 | — |
| University of Cincinnati | Cincinnati | Ohio | 45206-0829 | — |
| STAT Research | Dayton | Ohio | 45417 | — |
| Piedmont Arthritis Clinic, P.A. | Greenville | South Carolina | 29601 | — |
| Low Country Rheumatology, PA | Summerville | South Carolina | 29486 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Arthritis & Rheumatology Institute | Allen | Texas | 75013 | — |
| Office of John P. Lavery M.D., PA | Allen | Texas | 75013 | — |
| Tekton Research | Austin | Texas | 78745 | — |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | — |
| R and H Clinical Research | Katy | Texas | 77494 | — |
| Prime Clinical Research | Mansfield | Texas | 76063 | — |
| SouthWest Rheumatology Research, LLC | Mesquite | Texas | 75150 | — |
| Sun Research Institute, LLC | San Antonio | Texas | 78215 | — |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Swedish Medical Center | Seattle | Washington | 98104 | — |
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 133 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04961567, 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 Jan 28, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04961567 live on ClinicalTrials.gov.