drugset / Trial / NCT05421598

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

NCT05421598

Phase 2 Completed 437 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-06-30
Primary completion
2024-10-11
Completion
2025-03-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlitelimab Monoclonal antibody 62.5 mg Subcutaneous
Subject Amlitelimab Monoclonal antibody 125 mg Subcutaneous
Subject Amlitelimab Monoclonal antibody 250 mg Subcutaneous

Indications