This is a parallel, treatment, Phase 2, double-blind, 2 arm, 12-week Proof of Concept (PoC)
study 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 inhaled 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Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment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)
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.