At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SAR440340, Dupilumab, and 3 other interventions for Asthma. Completed, enrolled 296 participants across 71 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
Pharmaceutical form: Solution for Injection, Route of administration: SC
Pharmaceutical form: Solution for Injection, Route of administration: SC
Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled
Pharmaceutical form: Solution for Injection, Route of administration: SC
Pharmaceutical form: Solution for Injection, Route of administration: SC