Phase 2/3 Study to Evaluate BIIB059 in Active CLE
- Conditions
- Active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to
- Registration Number
- JPRN-jRCT2031230262
- Lead Sponsor
- Cho Kyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 474
histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
- Must have active cutaneous manifestations that meet criteria
- Must have a CLASI-A score >= 10
- Must have an active CLE lesion despite an adequate trial of antimalarial treatment
NOTE: Other protocol defined Inclusion criteria may apply.
- Any active skin conditions other than CLE that may interfere with the study assessments of CLE
- Active severe lupus nephritis
- Active neuropsychiatric SLE
- Use of intralesional corticosteroids within 1 week prior to Screening and during the study
- Use of immunosuppressive or disease-modifying treatments for SLE or CLE (via an oral, IV, or SC route) that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose
NOTE: Other protocol defined Exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method