CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 437 enrolled
Drug / intervention
Amlitelimab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05421598
NCT05421598Phase 2Completed

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

Sanofi·interventional·Posted Jun 16, 2022·Updated Mar 30, 2026

In Brief

A Phase 2 clinical trial evaluating Amlitelimab and Placebo for Asthma. Completed, enrolled 437 participants across 113 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Brazil, Canada, Chile, Hungary, Italy, Japan, Mexico, Poland, South Africa, South Korea, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJun 16, 2022
Enrollment StartJun 30, 2022
Primary CompletionOct 11, 2024
Study CompletionMar 20, 2025
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.0 years ago

Interventions

Amlitelimabdrug

Injection solution Subcutaneous injection

Placebodrug

Injection solution Subcutaneous injection