Trials / Completed
CompletedNCT02477332
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 382 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | QGE031 | |
| BIOLOGICAL | Omalizumab | |
| OTHER | Placebo |
Timeline
- Start date
- 2015-07-15
- Primary completion
- 2016-11-02
- Completion
- 2017-06-12
- First posted
- 2015-06-22
- Last updated
- 2021-01-05
- Results posted
- 2018-09-14
Locations
82 sites across 10 countries: United States, Australia, Canada, Germany, Greece, Japan, Russia, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02477332. Inclusion in this directory is not an endorsement.