Status:
ENROLLING_BY_INVITATION
An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Lead Sponsor:
Biogen
Conditions:
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or pl...
Eligibility Criteria
Inclusion
- Key
- Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52.
- Key
Exclusion
- Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
- Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period)
- Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)
- Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
- NOTE: Other inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 29 2030
Estimated Enrollment :
864 Patients enrolled
Trial Details
Trial ID
NCT05352919
Start Date
June 10 2022
End Date
March 29 2030
Last Update
January 8 2026
Active Locations (174)
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1
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, United States, 85037
2
Wallace Rheumatic Study Center
Beverly Hills, California, United States, 90211
3
Care Access Research - Huntington Beach
Huntington Beach, California, United States, 92648
4
Providence Facey Medical Foundation
Mission Hills, California, United States, 91345