NCT06033833

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Amlitelimab	Injection Solution: by subcutaneous injection (SCI)
DRUG	Placebo	Injection Solution: by subcutaneous injection (SCI)

Timeline

• Start date: 2023-09-05
• Primary completion: 2029-06-25
• Completion: 2029-06-25
• First posted: 2023-09-13
• Last updated: 2025-09-22

Locations

68 sites across 14 countries: United States, Argentina, Brazil, Canada, Chile, Hungary, Italy, Japan, Mexico, Poland, South Africa, South Korea, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study