Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.
Phase 1
- Conditions
- refractory bullous pemphigoidMedDRA version: 18.0Level: LLTClassification code 10006567Term: Bullous pemphigoidSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-003370-10-FR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Patients diagnosed with bullous phemphigoid
- Stable dose of prednisone at or above 10mg per day but no greather than 1mg/kg/day
- Weight between 40-120kg
- Total IgE level up to 5000 IU/mL
listing incomplete, additional inclusion criteria applicable
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
Exclusion Criteria
- Use of rifuximab within 1 year
listing incomplete, additional exclusion criteria applicable
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method