Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment
NCT ID: NCT01688882
Last Updated: 2016-04-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
20 participants
INTERVENTIONAL
2013-01-31
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid
NCT07210554
Pilot Efficacy and Safety Study of Oral DF2156A in Patients With Active Bullous Pemphigoid
NCT01571895
A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
NCT05681481
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases
NCT06342713
A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria
NCT01987947
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QGE031
QGE031 240 mg Q2W s.c.
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
Placebo to Match Q2W s.c.
Placebo
Placebo will be used to control for normal variability in disease severity.
Open Label QGE031
Open Label QGE031 Q2W s.c.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Placebo will be used to control for normal variability in disease severity.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CQGE031X2202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.