NCT05421598

Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 437 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study was to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: * The study duration (per participant) was up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. * The randomized treatment duration was up to approximately 60 weeks. * The scheduled number of visits was 13.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Amlitelimab	Injection solution Subcutaneous injection
DRUG	Placebo	Injection solution Subcutaneous injection

Timeline

• Start date: 2022-06-30
• Primary completion: 2024-10-11
• Completion: 2025-03-20
• First posted: 2022-06-16
• Last updated: 2026-03-30
• Results posted: 2026-03-30

Locations

113 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