LTS17231 Phase 2 study
Research type
Research Study
Full title
An open label extension study to evaluate the long-term safety and efficacy of subcutaneous lunsekimig in adult participants with moderate-to-severe asthma who participated in study DRI16762
IRAS ID
1010328
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
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. This is a Phase 2, Long term extension study to evaluate the safety and efficacy of lunsekimig in adult participants with moderate-to-severe asthma who have previously completed the parent study. The purpose of this study is to evaluate long-term safety and efficacy in participants receiving SC administered lunsekimig 300 mg Q4W. The study duration will be up to 100 weeks and the treatment duration will be up to 96 weeks. The minimal number of on-site visits will be 14; additional 12 visits (whether performed at home or at the clinic) will be dedicated to the lunsekimig injection. It is anticipated that long-term exposure will be safe, well tolerated, and result in sustained efficacy.REC name
Wales REC 1
REC reference
25/WA/0003
Date of REC Opinion
19 Mar 2025
REC opinion
Further Information Favourable Opinion