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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 rilzabrutinib in participants 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 rilzabrutinib in participants 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: 20 Feb 2025

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At a glance

  • Drugs Rilzabrutinib (Primary)
  • Indications Asthma
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement

Most Recent Events

  • 22 May 2024 Results (n=64) assessing Efficacy and Safety of Rilzabrutinib in asthma patients presented at the 120th International Conference of the American Thoracic Society
  • 26 Apr 2024 According to a Sanofi media release, data from this study will be presented at the American Thoracic Society (ATS) International Conference taking place from May 17-22 in San Diego.
  • 25 Apr 2024 According to a Sanofi media release, results from second (high-dose) cohort of this trial were presented in a financial report.

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