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NCT01312961 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT01312961 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 104 participants.
The verdict
NCT01312961, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma. Secondary Objectives: * To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma. * To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
Interventions
- DRUG Dupilumab
- DRUG Albuterol
- DRUG Placebo (for Dupilumab)
- DRUG Fluticasone/Salmeterol combination therapy
- DRUG Fluticasone monotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01312961
The ClinicalTrials.gov registry entry for NCT01312961 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 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 Dupilumab is the first listed.
NCT01312961 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01312961 about?
NCT01312961 is a clinical study titled "Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma". Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma. Secondary Ob...
What is the current status of trial NCT01312961?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2011-03. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01312961?
The interventions under investigation include: Dupilumab (DRUG), Albuterol (DRUG), Placebo (for Dupilumab) (DRUG), Fluticasone/Salmeterol combination therapy (DRUG), Fluticasone monotherapy (DRUG).
Who is sponsoring clinical trial NCT01312961?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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