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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 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 2,538 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03052517
The ClinicalTrials.gov registry entry for NCT03052517 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 2,538 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03052517 reports 0 study locations.
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.
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