Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment
| Status: | Terminated |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 20 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | March 2015 |
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Bullous Pemphigoid With Disease Refractory to Oral Steroid Treatment
To evaluate the safety and efficacy of QGE031 versus placebo in patients with bullous
pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is
broken down by the body and the impact it has on different blood and tissue markers will
also be explored.
pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is
broken down by the body and the impact it has on different blood and tissue markers will
also be explored.
Inclusion Criteria:
- Patients diagnosed with bullous pemphigoid
- Stable dose of prednisone at or above 10mg per day but no greater than 1 mg/kg/day
- Weigh between 40-120kg
- total IgE level up to 5000 IU/mL
Exclusion Criteria:
- Use of rituximab within 1 year
Other protocol-defined inclusion/exclusion criteria may apply
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