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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 437 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05421598
The ClinicalTrials.gov registry entry for NCT05421598 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 437 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05421598 reports 0 study locations.
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.
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