Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.

• Conditions: Refractory Bullous Pemphigoid; MedDRA version: 15.0Level: LLTClassification code 10006567Term: Bullous pemphigoidSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-003370-10-AT
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-03
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

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
Main Objective: To demonstrate the efficacy of QGE031 240mg q2w relative to placebo at 12 weeks in patients with BP by reducing disease activity as determined by Clinical Global Assessment of Change (CGA-C) responder rate.;Secondary Objective: 1.To evaluate the CGA-C responder rate in QGE031 240mg q2w vs. Placebo treated patients at 6 weeks<br>2.To evaluate the effect of QGE031 240mg q2w in BP patients as assessed by Investigator Global Assessment (IGA)<br>3.To evaluate the safety of QGE031 in BP patients<br>;Primary end point(s): Change in the Clinical Global Assessment of change from baseline to week 12.;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change in the Clinical Global Assessment of change from baseline to week 6. <br>- Change from baseline in the Investigator Global Assessment over 48 weeks.<br>- Safety of QGE031 over 48 weeks.;Timepoint(s) of evaluation of this end point: - 6 weeks<br>- baseline, every 2 weeks up to 12 weeks, every 4 weeks up to 24 weeks, every 8 weeks up to 48 weeks<br>- baseline, every 2 weeks up to 12 weeks, every 4 weeks up to 24 weeks, every 8 weeks up to 48 weeks<br>