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NCT06280391 · ClinicalTrials.gov registry record · Phase 2
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 312
- Enrollment target
NCT06280391 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 312 participants.
The verdict
NCT06280391, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 312 participants
- Enrollment target
Study Summary
ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. * The treatment duration will be up to 24-52 weeks. * The follow-up duration will be 20 weeks. * Site/phone visits are at a monthly interval.
Interventions
- DRUG Placebo
- DRUG Itepekimab (SAR440340)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2024-02-20 |
| Est. Completion | 2026-02-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06280391
The ClinicalTrials.gov registry entry for NCT06280391 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 312 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.
NCT06280391 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06280391 about?
NCT06280391 is a clinical study titled "A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis". ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants w...
What is the current status of trial NCT06280391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 312 participants. The study started on 2024-02-20. Estimated completion is 2026-02-02.
What interventions are being tested in trial NCT06280391?
The interventions under investigation include: Placebo (DRUG), Itepekimab (SAR440340) (DRUG).
Who is sponsoring clinical trial NCT06280391?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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