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NCT02477332 · ClinicalTrials.gov registry record · Phase 2
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 382
- Enrollment target
NCT02477332: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02477332 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 382 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (187% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02477332, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 382 participants
- Enrollment target
Study 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.
Primary Outcome
The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks). Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a p
Interventions
- OTHER Placebo
- BIOLOGICAL Omalizumab
- BIOLOGICAL QGE031
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2015-07-15 |
| Est. Completion | 2017-06-12 |
| Phase | Phase 2 |
What the finished NCT02477332 record still lists
NCT02477332 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (187% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02477332 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02477332 about?
NCT02477332 is a clinical study titled "Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU". 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.
What is the current status of trial NCT02477332?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 382 participants. The study started on 2015-07-15. Estimated completion is 2017-06-12.
What interventions are being tested in trial NCT02477332?
The interventions under investigation include: Placebo (OTHER), Omalizumab (BIOLOGICAL), QGE031 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02477332?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02477332's enrollment target sits among peer trials
382 111th of 2000 higher than 1,890 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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