drugset / Trial / NCT01688882

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

NCT01688882 ↗

Phase 2 Terminated 20 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-01
Primary completion
2015-03
Completion
2015-03

Outcome

Outcome not reported

Stopped: “This study was stopped after Part 1 completed and was terminated because the predefined criteria of efficacy was not reached ( \>50% better then placebo)”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ligelizumab Monoclonal antibody 240 mg Subcutaneous

Indications