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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Bullous Pemphigoid

In brief

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.

Key facts

Study ID

NCT01688882

Run by

Novartis Pharmaceuticals

People needed

20

Starts

2013-01-01

Expected to finish

2015-03-01

Last updated by the study team

2016-04-28

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Novartis Investigative Site — Iowa City, Iowa, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Rouen, Cedex, France
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Freiburg im Breisgau, Germany
• Novartis Investigative Site — Marburg, Germany
• Novartis Investigative Site — Shinjuku-ku, Tokyo, Japan
• Novartis Investigative Site — Taipei, Taiwan, Taiwan

Full record on ClinicalTrials.gov

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