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
Study identification
- NCT ID
- NCT04961567
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Biogen
- Industry
- Enrollment
- 562 participants
Conditions and interventions
Conditions
Interventions
- Litifilimab Drug
- Placebo Drug
Drug
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 May 12, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04961567 live on ClinicalTrials.gov.