Study of efficacy, safety and blood-related changes of QGE031 in bullous pemphigoid patients not responding adequately to oral steroid treatment
Phase 2
- Conditions
- Bullous pemphigoid
- Registration Number
- JPRN-jRCT2080222213
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
*Patients diagnosed with bullous pemphigoid
*Stable dose of prednisone at or above 10 mg per day but no greater than 1 mg/kg/day
*Weigh between 40-120kg
*Total IgE level up to 5000 IU/mL
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
*Use of rituximab within 1 year
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Clinical Global Assessment of Change from Baseline to Week 12
- Secondary Outcome Measures
Name Time Method Change in the Clinical Global Assessment of Change from Baseline to Week 6<br><br>Change from baseline in the Investigator Global Assessment over 48 weeks<br><br>Safety of QGE031 over 48 weeks