Active Not Recruiting PHASE3 INTERVENTIONAL 3-arm NCT06181435

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, Randomized, Double-blind, Placebo-controlled, Parallelgroup, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Sponsor: Sanofi

Conditions Dermatitis Atopic

Interventions Amlitelimab Placebo

Updated 19 times since 2024 Last updated: Dec 3, 2025 Started: Dec 21, 2023 Primary completion: Nov 25, 2025 Completion: Mar 18, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Dermatitis Atopic, this trial is ongoing. The trial is conducted by Sanofi and has accumulated 19 data snapshots since 2023. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

19 versions recorded

Jan 2026 — Present [monthly]

Active Not Recruiting PHASE3
Sep 2025 — Jan 2026 [monthly]

Active Not Recruiting PHASE3
Jul 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Jun 2025 — Jul 2025 [monthly]

Recruiting PHASE3
May 2025 — Jun 2025 [monthly]

Recruiting PHASE3

▶ Show 14 earlier versions

Apr 2025 — May 2025 [monthly]

Recruiting PHASE3
Feb 2025 — Apr 2025 [monthly]

Recruiting PHASE3
Jan 2025 — Feb 2025 [monthly]

Recruiting PHASE3
Dec 2024 — Jan 2025 [monthly]

Recruiting PHASE3
Nov 2024 — Dec 2024 [monthly]

Recruiting PHASE3
Oct 2024 — Nov 2024 [monthly]

Recruiting PHASE3
Sep 2024 — Oct 2024 [monthly]

Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE3
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE3
May 2024 — Jun 2024 [monthly]

Recruiting PHASE3
Apr 2024 — May 2024 [monthly]

Recruiting PHASE3
Feb 2024 — Apr 2024 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Jan 2024 — Feb 2024 [monthly]

Not Yet Recruiting PHASE3

First recorded

Dec 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sanofi

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aalborg, Denmark , Aarhus, Denmark , Aguascalientes, Mexico , Albuquerque, United States , Antalya, Turkey (Türkiye) , Arlington, United States , Beijing, China , Berazategui, Argentina , Bexley, United States , Boksburg, South Africa and 105 more locations