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

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2015 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01688882

First received: September 17, 2012

Last updated: January 15, 2015

Last verified: January 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2012

Last Updated Date

January 15, 2015

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in the Clinical Global Assessment of Change from Baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01688882 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in the Clinical Global Assessment of Change from Baseline to Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change from baseline in the Investigator Global Assessment over 48 weeks [ Time Frame: Baseline, every 2 weeks up to 12 weeks, every 4 weeks up to 24 weeks, every 8 weeks up to 48 weeks ] [ Designated as safety issue: No ]
Safety of QGE031 over 48 weeks [ Time Frame: Baseline, ever 2 weeks up to 12 weeks, every 4 weeks up to 24 weeks, every 8 weeks up to 48 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Bullous Pemphigoid

Intervention ^ICMJE

Drug: QGE031
QGE031 will be evaluated at various dose levels and regimens, based on the impact on disease of the next highest dose level and regimen.
Drug: Placebo
Placebo will be used to control for normal variability in disease severity.

Study Arm (s)

Experimental: High dose QGE031 with interval 1
Intervention: Drug: QGE031
Experimental: High dose QGE031 with interval 2
Intervention: Drug: QGE031
Experimental: Low dose QGE031 with interval 2
Intervention: Drug: QGE031
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2015

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals	1-888-669-6682
Contact: Novartis Pharmaceuticals

Listed Location Countries ^ICMJE

United States, Austria, France, Germany, Japan, Taiwan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01688882

Other Study ID Numbers ^ICMJE

CQGE031X2202

Has Data Monitoring Committee

Yes

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top