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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 894 participants.

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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).

Interventions

  • DRUG Placebo
  • DRUG QAW039

Trial Details

FieldValue
Enrollment Target 894 participants
Start Date 2015-12-11
Est. Completion 2019-11-04
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT02555683

The ClinicalTrials.gov registry entry for NCT02555683 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 894 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 2 interventions - of which Placebo is the first listed.

NCT02555683 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.