NCT05104892

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

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: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment period and resumed at the end of the IMP treatment period, as outlined below: * Screening period (4 weeks) * Randomized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)

Detailed 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Rilzabrutinib	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	placebo	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2021-12-12
• Primary completion: 2024-02-06
• Completion: 2024-02-28
• First posted: 2021-11-03
• Last updated: 2024-03-07

Locations

51 sites across 13 countries: Argentina, Bulgaria, Canada, Chile, Germany, Hungary, Mexico, Poland, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom