*AIRLYMPUS
Research type
Research Study
Full title
A randomised, Phase 2, double-blind, placebo-controlled, parallel-group, 2-arm study to investigate the efficacy, safety, and tolerability of subcutaneous lunsekimig (SAR443765) in adult participants with high-risk asthma who are not currently eligible for biologic treatment
IRAS ID
1010669
Contact name
Patrick Maury
Contact email
Sponsor organisation
Aventis Pharma Limited, trading as Sanofi
Eudract number
2024-513959-33
Clinicaltrials.gov Identifier
Research summary
Asthma is a chronic inflammatory disease that affects the airways in the lungs leading to symptoms such as wheezing, shortness of
breath, cough and chest tightness. New treatments to improve asthma symptoms, lung function and quality of life are needed. The
main objective of this ACT18301 study is to assess the effectiveness and safety of lunsekimig for the treatment of adults with high-risk asthma who are not eligible for biologic treatment. The addition of lunsekimig to the usual treatment approach could improve health outcomes and occurrence of asthma exacerbations. This study has 2 parts: Part A, where participants will receive stable inhaled corticosteroid treatment at a higher dose that usually taken. Part B, is the treatment period which is double-blinded where eligible participants are either treated with lunsekimig or placebo (inactive medicine) for 52 weeks. "Double-blind" means that neither the participant nor the study doctor knows who is given the study medicine (lunsekimig) or the inactive medicine (placebo). This is to ensure that the study results are not influenced by anyone in any way. The study will end when all the events pre specified in the protocol is reached. This study will help the Sponsor find out if this new treatment approach is better, the same, or worse than the usual treatment approach for patients with asthma and elevated markers of active inflammation. To decide if it is better, the study Sponsor will be examining whether lunsekimig reduces asthma exacerbations, improves breathing, and improves asthma-associated symptoms compared to placebo (inactive medicine).REC name
Wales REC 2
REC reference
24/WA/0252
Date of REC Opinion
23 Oct 2024
REC opinion
Further Information Favourable Opinion