AIRCULES
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to assess the efficacy, safety, and tolerability of subcutaneous lunsekimig (SAR443765) in adult participants with moderate to severe asthma.
IRAS ID
1009790
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi Pasteur Inc.
Eudract number
2023-503712-33
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 DRI16762 study is to assess the effectiveness and safety of the experimental medicine lunsekimig for the treatment of adults with moderate to severe asthma. This is a dose ranging double-blind study where eligible participants are either treated with lunsekimig or an inactive medicine (placebo) for 48 weeks. A total of 4 dosing groups plus an inactive medicine group will be tested in this study. "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 provide information to select the ultimate dose required for future asthma treatments.
REC name
North East - York Research Ethics Committee
REC reference
24/NE/0048
Date of REC Opinion
9 May 2024
REC opinion
Further Information Favourable Opinion