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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: Completed Phase 2 study, sponsored by Sanofi.
NCT03387852 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 296 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An LOAC event during the 12-week treatment period was a deterioration of asthma defined as any of the following: a) 30 percent (%) or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; b) greater than or equal to (\>=) 6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; c) increase in inhaled corticosteroid (ICS) \>=4 times the last prescribed ICS dose (or \>
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 |
What the finished NCT03387852 record still lists
NCT03387852 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 5 interventions - of which Dupilumab is the first listed.
NCT03387852 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03387852's enrollment target sits among peer trials
296 189th of 2000 higher than 1,812 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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