Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma

Asthma Clinical Trial

Official title: 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

Clinical Trial Summary

This is a parallel, treatment, Phase 2, double-blind, 2 arm, 12-week Proof of Concept (PoC) study with 2 staggered cohorts (2 arms in each cohort) that is designed to assess the efficacy, safety, and tolerability of rilzabrutinib in adult participants (aged 18-70 years) with moderate-to-severe asthma who are not well controlled on ICS/LABA therapy. Study treatment includes investigational medicinal product (IMP) (rilzabrutinib or placebo) added-on to a background therapy of ICS/LABA (fluticasone/salmeterol [non-investigational medicinal product], standardized at screening). Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment period and resumed at the end of the IMP treatment period, as outlined below:

• Screening period (4 weeks)

• Randomized IMP treatment period (12 weeks ± 3 days)

• Background therapy stabilization phase (4 weeks)

• Background therapy withdrawal phase (4-5 weeks)

• No background therapy phase (3-4 weeks)

• Post IMP treatment safety follow-up period (4 weeks ± 3 days)

Clinical Trial Description

The total study duration per participant is expected to be up to 20 weeks: up to 4 weeks screening, 12 weeks on-treatment double-blind period, and 4-week post-IMP treatment follow up. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT05104892
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 2
• Start date: December 12, 2021
• Completion date: February 28, 2024