Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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