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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

Description

Brief 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.


Detailed Description
This study was planned to be divided into 2 distinct parts. Part 1 was a multicenter, randomized, placebo-controlled study evaluating the efficacy, safety, PK and PD of multiple, subcutaneous doses of QGE031 in the treatment of patients with BP with disease refractory to oral steroid treatment. Patients were treated with QGE031 or placebo in a 2:1 ratio. Part 2 of this study was planned to be a multi-center, open label, dose range finding study evaluating the efficacy, safety, PK and PD of multiple, subcutaneous doses of QGE031 in the treatment of patients with BP with disease refractory to oral steroid treatment. This study was stopped after Part 1 completed and was terminated because the predefined criteria of efficacy was not reached ( >50% better then placebo)

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion 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

  • Use of rituximab within 1 year Other protocol-defined inclusion/exclusion criteria may apply

Sites

  • California

    • Novartis Investigative Site, Los Angeles, California, 90033
    • Novartis Investigative Site, Los Angeles, California, 90033

  • Iowa

    • Novartis Investigative Site, Iowa City, Iowa, 52242

  • Taiwan

    • Novartis Investigative Site, Niaosong Township, 83301
    • Novartis Investigative Site, Niaosong Township, 83301

  • Germany

    • Novartis Investigative Site, Freiburg, 79104
    • Novartis Investigative Site, Freiburg, 79104
    • Novartis Investigative Site, Marburg, 35039
    • Novartis Investigative Site, Marburg, 35039

  • Cedex

    • Novartis Investigative Site, Rouen, Cedex, 76031
    • Novartis Investigative Site, Rouen, Cedex, 76031
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