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NCT03052517 · ClinicalTrials.gov registry record · Phase 3
Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,538
- Enrollment target
NCT03052517: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03052517 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 2,538 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (229% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03052517, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,538 participants
- Enrollment target
Study Summary
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.
Primary Outcome
Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported.
Interventions
- DRUG Placebo
- DRUG QAW039 150 mg
- DRUG QAW039 450 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,538 participants |
| Start Date | 2017-03-21 |
| Est. Completion | 2020-03-16 |
| Phase | Phase 3 |
Why NCT03052517 stopped before completion
NCT03052517 is an interventional study that assigns participants to a tested intervention. Its 2,538 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (229% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03052517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03052517 about?
NCT03052517 is a clinical study titled "Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment". This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 stan...
What is the current status of trial NCT03052517?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,538 participants. The study started on 2017-03-21. Estimated completion is 2020-03-16.
What interventions are being tested in trial NCT03052517?
The interventions under investigation include: Placebo (DRUG), QAW039 150 mg (DRUG), QAW039 450 mg (DRUG).
Who is sponsoring clinical trial NCT03052517?
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 NCT03052517's enrollment target sits among peer trials
2,538 87th of 2000 higher than 1,914 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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