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NCT02555683 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 894
- Enrollment target
NCT02555683: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02555683 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 894 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02555683, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 894 participants
- Enrollment target
Study Summary
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: * patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) * patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).
Primary Outcome
A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department
Interventions
- DRUG Placebo
- DRUG QAW039
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 894 participants |
| Start Date | 2015-12-11 |
| Est. Completion | 2019-11-04 |
| Phase | Phase 3 |
What the finished NCT02555683 record still lists
NCT02555683 is an interventional study that assigns participants to a tested intervention. The registered 894 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02555683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02555683 about?
NCT02555683 is a clinical study titled "Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.". This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: * patient with inadequately controlle...
What is the current status of trial NCT02555683?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 894 participants. The study started on 2015-12-11. Estimated completion is 2019-11-04.
What interventions are being tested in trial NCT02555683?
The interventions under investigation include: Placebo (DRUG), QAW039 (DRUG).
Who is sponsoring clinical trial NCT02555683?
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 NCT02555683's enrollment target sits among peer trials
894 363rd of 2000 higher than 1,638 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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