RIVER-ASTHMA
Research type
Research Study
Full title
A long-term extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous amlitelimab in adult participants with moderate-to-severe asthma who completed treatment period of previous amlitelimab asthma clinical study
IRAS ID
1008141
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-503385-24
ISRCTN Number
160787
Research summary
The purpose of this long-term extension (LTS) study is to check safety, how well tolerated and effective the study drug; amlitelimab is in adult patients with moderate-to-severe asthma who completed the treatment period of previous amlitelimab asthma clinical study (DRI17509). Only participants who were in the existing study centres & completed the treatment period this the parent study and their study doctor believe they will benefit longer term using this study drug, can be included. Amlitelimab is a monoclonal antibody (a type of protein made in a lab) that is aimed at targeting the harmful agents (antigens) created during an asthma allergic reaction and prevent patients becoming unwell. The parent study is an ongoing Phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study assessing the efficacy, safety, and tolerability of SC amlitelimab in adult participants with moderate-to-severe asthma. The main goal of DRI17509 check if the rate of severe asthma exacerbation events over 48 weeks is lowered, breathing capacity improved and they feel better overall. Also they do not need to attend A&E so frequently for emergency care. Several dosing regimens are tested in the parent study: Amlitelimab 250 mg, 125 mg and 62.5 mg or placebo with administration once every 4 weeks for the first 6 doses and then every 12 weeks for the remainder of the 60 weeks treatment period. After this they can enter into the LTS study, all participants will receive amlitelimab 250mg. The aim to to provide a long-term safety data to better identify potential later adverse events (AEs) associated with the use of amlitelimab. It is given as add-on therapy to
background therapy with standard asthma and additional controller medications. How amlitelimab works in the body and how it is broken down and removed from the body will also be reviewed over the course of the study to deepen the scientific understanding of amlitelimab effects in moderate-to-severe asthma.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0604
Date of REC Opinion
25 Sep 2023
REC opinion
Further Information Favourable Opinion