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NCT03387852 · ClinicalTrials.gov registry record · Phase 2
Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 296
- Enrollment target
NCT03387852 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 296 participants.
The verdict
NCT03387852, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 296 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events. Secondary Objectives: To evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340 and dupilumab, compared with placebo, on forced expiratory volume in 1 second (FEV1). To evaluate the effects of coadministration of SAR440340 and dupilumab, compared with SAR440340 and compared with dupilumab, on FEV1. To assess safety and tolerability of SAR440340 alone and in coadministration with dupilumab.
Interventions
- DRUG Dupilumab
- DRUG SAR440340
- DRUG Fluticasone or Fluticasone/salmeterol combination
- DRUG Placebo for SAR440340
- DRUG Placebo for dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2018-03-12 |
| Est. Completion | 2019-08-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03387852
The ClinicalTrials.gov registry entry for NCT03387852 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 296 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.
NCT03387852 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03387852 about?
NCT03387852 is a clinical study titled "Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants". Primary Objective: To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events. Secondary Objectives: To evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340 and dupilumab, compare...
What is the current status of trial NCT03387852?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 296 participants. The study started on 2018-03-12. Estimated completion is 2019-08-07.
What interventions are being tested in trial NCT03387852?
The interventions under investigation include: Dupilumab (DRUG), SAR440340 (DRUG), Fluticasone or Fluticasone/salmeterol combination (DRUG), Placebo for SAR440340 (DRUG), Placebo for dupilumab (DRUG).
Who is sponsoring clinical trial NCT03387852?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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