A Study to Evaluate the Continuous Safety and Efficacy of BIIB059 in Adults With Active Systemic Lupus Erythematosus

• Status: Not yet recruiting
• Trial end date: 2029-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of BIIB059 in participants with active systemic lupus erythematosus (SLE).

The secondary objectives of this study are to evaluate the long-term effect of BIIB059 on disease activity in participants with SLE, to evaluate the long-term effect of BIIB059 in participants with SLE in maintaining low disease activity, to evaluate the effect of BIIB059 in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving BIIB059 treatment, to assess the impact of BIIB059 on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of BIIB059 on laboratory parameters, and to evaluate immunogenicity of BIIB059.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen

Criteria

Key Inclusion Criteria:

• 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 BIIB059 or placebo to Week 48 and attended the last study assessment visit at Week 52

Key Exclusion Criteria:

• 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 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.