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

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

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (superiority test); Placebo vs Amlitelimab 125 mg With 250 mg Loading Dose; p = 0.0075; Rate ratio 0.522 (95% CI 0.324 to 0.840) reads as met primary endpoint NCT05421598 ↗

release “NCT05421598) show that the primary endpoint of annualized exacerbation rate at week 48 was not met” reads as missed primary endpoint sanofi.com ↗

Publications

• Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlitelimab	Monoclonal antibody	62.5 mg	Subcutaneous
Subject	Amlitelimab	Monoclonal antibody	125 mg	Subcutaneous
Subject	Amlitelimab	Monoclonal antibody	250 mg	Subcutaneous

Indications