BP44551 Asthma Study
Research type
Research Study
Full title
A Phase Ib, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of Selnoflast In Participants With Moderate To Severe Asthma.
IRAS ID
1008183
Contact name
Deepak Pardhi
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Research summary
Asthma is a chronic inflammatory disease of the airways leading to cough, wheeze, shortness of breath, and chest tightness. Asthma symptoms are driven by inflammation of the airways, which triggers processes such as mucus production, remodelling of the airway wall, and bronchial hyper-responsiveness. Despite the availability of effective treatments, asthma still causes significant disease burden and mortality. New treatments are needed to address the unmet need.
NLRP3 levels (along with sputum IL-1β, and sputum IL-1β levels) all increase with asthma severity and are more pronounced during acute asthma exacerbation compared with stable disease state. Selnoflast is a new drug that targets NLRP3, thereby lessening inflammation in the lungs.
The study described here will evaluate the safety, pharmacokinetics, and pharmacodynamics of selnoflast. In addition, it aims to test the hypothesis that blocking the NLRP3 inflammasome with selnoflast dampens inflammation in the lungs of patients with asthma.Approximately 60 participants with moderate to severe asthma will be randomized on a 1:1 basis (30 in each treatment group). However, the sample size may be increased up to a maximum of 90 participants. The UK will recruit approx. 27 patients across 6/7 sites.
The study has a duration of approximately 11 weeks for each participant.The study is sponsored by F. Hoffmann- La Roche
Research Summary; Version Number 1 dated 31-Aug-2023REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0223
Date of REC Opinion
26 Oct 2023
REC opinion
Further Information Favourable Opinion