Proof of concept study of rilzabrutinib in adult participants with moderate-to-severe asthma
Research type
Research Study
Full 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
IRAS ID
1003981
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
Sanofi aventis recherche et developpement
Eudract number
2021-002490-26
Clinicaltrials.gov Identifier
Research summary
Asthma is a chronic inflammatory disease of the airways. The inflammation is thought to he caused by the action of many cell types (known as B cells) and their secretions into the blood system. Even with current treatment options such as inhaled corticosteroids combined with a second inhaler some patients continue to have uncontrolled Asthma leading to severe exacerbations resulting in more hospitalisations, AE visits and lost days of school / work. In addition the corticosteroids although effective have side effects of their own such as fluid retention, increase blood pressure, increased risk of infections, diabetes and osteoporosis.
For the severely uncontrolled asthmatic patients there are several approved biologic treatments which have shown to work, however these treatments are given intravenously (injection through a vein) every 4-6 weeks and patients often do not comply with this treatment regimen leading to their asthma remaining uncontrolled.The main objective of new treatments is to improve the symptoms, lung function and prevent attacks whilst also improving the patient’s compliance to the treatment.
Bruton’s Tyrosine Kinase (BTK) is a “receptor” found on all B cells and when activated enables these B cells to produce the secretions known to cause inflammation which in turn exacerbates a patient’s asthma. Rilzabrutinib is a BTK Inhibitor and prevents the activation of BTK on the B cells and therefore reduces the B cells secretions which reduces the inflammation in the airways. Rilzabrutinib is given via a tablet and it is hoped that this will help the patient be compliant with their medication.
The aim of this study is to assess the safety and effectiveness of Rilzabrutinib in patients with moderate to severe asthma.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0210
Date of REC Opinion
2 Nov 2021
REC opinion
Further Information Favourable Opinion