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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

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Trial Profile

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 of Trial: Phase II

Latest Information Update: 03 Feb 2023

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At a glance

  • Drugs Dupilumab (Primary) ; Itepekimab (Primary) ; Fluticasone propionate; Salmeterol/fluticasone propionate
  • Indications Asthma
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Regeneron Pharmaceuticals; Sanofi

    • Most Recent Events

    • 28 Oct 2021 Primary endpoint (Loss of asthma control (LOAC) events: Proportion of patients with LOAC on REGN3500 with Dupixent compared to placebo), has not been met as per results published in the New England Journal of Medicine.
    • 28 Oct 2021 Results assessing efficacy and safety of itepekimab in patients with moderate-to-severe asthma, published in the New England Journal of Medicine.
    • 20 May 2020 Results presented at the 116th International Conference of the American Thoracic Society
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