A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Public ClinicalTrials.gov record NCT06044337. 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, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
Study identification
- NCT ID
- NCT06044337
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Biogen
- Industry
- Enrollment
- 322 participants
Conditions and interventions
Interventions
- BIIB059 (litifilimab) 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
- Oct 2, 2023
- Primary completion
- Jun 25, 2029
- Completion
- Dec 10, 2029
- Last update posted
- May 4, 2026
2023 – 2029
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham - (UAB) | Birmingham | Alabama | 35233 | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix | Arizona | 85032 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | — |
| David Fivenson, MD, Dermatology, PLLC | Ann Arbor | Michigan | 48103 | — |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| Thurston Arthritis Research Center | Chapel Hill | North Carolina | 27599-7280 | — |
| Duke Dermatology South Durham | Durham | North Carolina | 27710 | — |
| University of Cincinnati Health Physicians Office Dermatology | Cincinnati | Ohio | 45219 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390-8896 | — |
| Precision Comprehensive Clinical Research Solutions | Grapevine | Texas | 76034 | — |
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 91 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06044337, 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 May 4, 2026 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06044337 live on ClinicalTrials.gov.