Phase 3 Long-term Extension Study to Evaluate BIIB059 in Active SLE
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- JPRN-jRCT2031220439
- Lead Sponsor
- Cho Kyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 864
Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 and 230LE304) on study treatments with either BIIB059 or placebo to Week 48 and attended the last study assessment visit at Week 52.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method