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NCT06181435 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 589
- Enrollment target
NCT06181435 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 589 participants.
The verdict
NCT06181435, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 589 participants
- Enrollment target
Study Summary
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).
Interventions
- DRUG Placebo
- DRUG Amlitelimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 589 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2026-03-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06181435
The ClinicalTrials.gov registry entry for NCT06181435 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 589 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.
NCT06181435 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06181435 about?
NCT06181435 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)". This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies ...
What is the current status of trial NCT06181435?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 589 participants. The study started on 2023-12-21. Estimated completion is 2026-03-12.
What interventions are being tested in trial NCT06181435?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG).
Who is sponsoring clinical trial NCT06181435?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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