drugset / Trial / NCT05421598
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
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
| 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 |