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NCT05421598 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 437
- Enrollment target
NCT05421598: Completed Phase 2 study, sponsored by Sanofi.
NCT05421598 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 437 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (229% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05421598, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 437 participants
- Enrollment target
Study 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.
Primary Outcome
Severe asthma exacerbation event was defined as worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of oral corticosteroids (OCS) for the treatment of asthma, a doubling of the dose for 3 or more days, or hospitalization or emergency room visit because of asthma requiring systemic corticosteroids. Annualized rate was the total number of severe asthma exacerbation events divided by the total observation duration and was e
Interventions
- DRUG Placebo
- DRUG Amlitelimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2025-03-20 |
| Phase | Phase 2 |
What the finished NCT05421598 record still lists
NCT05421598 is an interventional study that assigns participants to a tested intervention. The registered 437 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (229% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05421598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05421598 about?
NCT05421598 is a clinical study titled "Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma". 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-seve...
What is the current status of trial NCT05421598?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 437 participants. The study started on 2022-06-30. Estimated completion is 2025-03-20.
What interventions are being tested in trial NCT05421598?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG).
Who is sponsoring clinical trial NCT05421598?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05421598's enrollment target sits among peer trials
437 89th of 2000 higher than 1,912 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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