Trials / Completed
CompletedNCT01703312
A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma
A Randomized, Double-blind, Placebo- and Comparator-controlled Study Evaluating the Effect of Multiple Doses of QGE031 Compared to Omalizumab in Asthma Induced by Allergen Bronchial Provocation
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QGE031 | Drug administered by subcutaneous injection |
| DRUG | omalizumab | Drug administered by subcutaneous injection |
| DRUG | placebo | Drug administered by subcutaneous injection |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2012-10-10
- Last updated
- 2016-04-20
Locations
7 sites across 2 countries: Canada, Sweden
Source: ClinicalTrials.gov record NCT01703312. Inclusion in this directory is not an endorsement.