Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-29 @ 6:27 AM
Study NCT ID:
NCT05104892
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2021-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma
Sponsor:
Sanofi
Organization:
Study Overview
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment period and resumed at the end of the IMP treatment period, as outlined below: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)
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: