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.
Verified May 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01688882
First received: September 17, 2012
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bullous Pemphigoid |
Drug: QGE031 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in the Clinical Global Assessment of Change from Baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 42 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: High dose QGE031 with interval 1 |
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.
|
| Experimental: High dose QGE031 with interval 2 |
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.
|
| Experimental: Low dose QGE031 with interval 2 |
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.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo will be used to control for normal variability in disease severity.
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688882
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Locations
| United States, California | |
| Novartis Investigative Site | Not yet recruiting |
| Los Angeles, California, United States, 90033 | |
| United States, Iowa | |
| Novartis Investigative Site | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| United States, North Carolina | |
| Novartis Investigative Site | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Novartis Investigative Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Austria | |
| Novartis Investigative Site | Recruiting |
| Vienna, Austria | |
| France | |
| Novartis Investigative Site | Not yet recruiting |
| Rouen, Cedex, France, 76031 | |
| Germany | |
| Novartis Investigative Site | Recruiting |
| Dresden, Germany, 01307 | |
| Novartis Investigative Site | Recruiting |
| Freiburg i. Br, Germany, 79104 | |
| Novartis Investigative Site | Recruiting |
| Marburg, Germany, 35039 | |
| Japan | |
| Novartis Investigative Site | Not yet recruiting |
| Bunkyo-ku, Tokyo, Japan, 113-8431 | |
| Novartis Investigative Site | Not yet recruiting |
| Shinjuku-ku, Tokyo, Japan, 160-8582 | |
| Taiwan | |
| Novartis Investigative Site | Recruiting |
| Taipei, Taiwan, 10002 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01688882 History of Changes |
| Other Study ID Numbers: | CQGE031X2202 |
| Study First Received: | September 17, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration Austria: Agency for Health and Food Safety Germany: Paul-Ehrlich-Institut Taiwan: Center for Drug Evaluation France: Ministry of Health |
Keywords provided by Novartis:
|
bullous pemphigoid QGE031 |
Additional relevant MeSH terms:
|
Pemphigoid, Bullous Skin Diseases, Vesiculobullous Skin Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013