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NCT02528214 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
NCT02528214 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 210 participants.
The verdict
NCT02528214, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab in improving participants-reported outcomes. * To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.
Interventions
- DRUG Placebo
- DRUG Dupilumab
- DRUG Inhaled corticosteroid (ICS) therapy
- DRUG Albuterol/Salbutamol
- DRUG Oral corticosteroid therapy (prednisone/prednisolone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2015-10-15 |
| Est. Completion | 2017-11-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02528214
The ClinicalTrials.gov registry entry for NCT02528214 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02528214 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02528214 about?
NCT02528214 is a clinical study titled "Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma". Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the eff...
What is the current status of trial NCT02528214?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2015-10-15. Estimated completion is 2017-11-13.
What interventions are being tested in trial NCT02528214?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG), Inhaled corticosteroid (ICS) therapy (DRUG), Albuterol/Salbutamol (DRUG), Oral corticosteroid therapy (prednisone/prednisolone) (DRUG).
Who is sponsoring clinical trial NCT02528214?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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