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NCT02649218 · ClinicalTrials.gov registry record · Phase 2
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 226
- Enrollment target
NCT02649218: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02649218 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 226 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02649218, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 226 participants
- Enrollment target
Study Summary
A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201
Primary Outcome
The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest.
Interventions
- BIOLOGICAL Ligelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2016-05-24 |
| Est. Completion | 2019-05-02 |
| Phase | Phase 2 |
What the finished NCT02649218 record still lists
NCT02649218 is an interventional study that assigns participants to a tested intervention. The registered 226 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 (70% higher).
The record links to 0 conditions, and to 1 intervention - of which Ligelizumab is the first listed.
NCT02649218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02649218 about?
NCT02649218 is a clinical study titled "A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients". A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201
What is the current status of trial NCT02649218?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 226 participants. The study started on 2016-05-24. Estimated completion is 2019-05-02.
What interventions are being tested in trial NCT02649218?
The interventions under investigation include: Ligelizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02649218?
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 NCT02649218's enrollment target sits among peer trials
226 267th of 2000 higher than 1,734 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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