Trials / Completed
CompletedNCT03387852
Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 12-week Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety, and Tolerability of SAR440340 and the Coadministration of SAR440340 and Dupilumab in Patients With Moderate-to-Severe Asthma Who Are Not Well Controlled on Inhaled Corticosteroid (ICS) Plus Long-acting β2 Adrenergic Agonist (LABA) Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 296 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The total duration of the study (per participant) was approximately 36 weeks, including 4 weeks screening, 12 weeks treatment, and 20 weeks post-treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAR440340 | Pharmaceutical form: Solution for Injection, Route of administration: SC |
| DRUG | Dupilumab | Pharmaceutical form: Solution for Injection, Route of administration: SC |
| DRUG | Fluticasone or Fluticasone/salmeterol combination | Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled |
| DRUG | Placebo for SAR440340 | Pharmaceutical form: Solution for Injection, Route of administration: SC |
| DRUG | Placebo for dupilumab | Pharmaceutical form: Solution for Injection, Route of administration: SC |
Timeline
- Start date
- 2018-03-12
- Primary completion
- 2019-03-21
- Completion
- 2019-08-07
- First posted
- 2018-01-02
- Last updated
- 2022-06-14
- Results posted
- 2022-03-29
Locations
71 sites across 8 countries: United States, Argentina, Chile, Mexico, Poland, Russia, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03387852. Inclusion in this directory is not an endorsement.