Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma
Status:
Not yet recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
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Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment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)