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Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study — RIVER-ASTHMA  

Asthma Clinical Trial

Official 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

Clinical Trial Summary

This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.

Clinical Trial Description

The duration of the study for each participant will be up to 156 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06033833
Study type Interventional
Source Sanofi
Contact Trial transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email contact-us@sanofi.com
Status Recruiting
Phase Phase 2
Start date September 5, 2023
Completion date June 25, 2029
View Details
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