ClinicalTrials.gov record
Enrolling by invitation Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06044337

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.

ClinicalTrials.gov public records Last synced May 6, 2026, 6:34 PM EDT

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.

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