A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Dermatitis Atopic

In brief

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The primary objective of ESTUARY is to assess the maintenance of treatment response on continued Q12W dosing compared to treatment withdrawal. Study details include: The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD). The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY).

Key facts

Study ID

NCT06407934

Run by

Sanofi

People needed

1541

Starts

2024-05-08

Expected to finish

2027-03-17

Last updated by the study team

2026-07-10

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
• Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
• Able and willing to comply with requested study visit and procedures.
• Body weight must be ≥ 25 kg.

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Developed a medical condition that would preclude participation as described in Exclusion Criteria or Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.
• Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
• Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
• Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
• Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
• Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Center for Dermatology and Plastic Surgery- Site Number : 8401119 — Scottsdale, Arizona, United States
• Scottsdale Clinical Trials- Site Number : 8401149 — Scottsdale, Arizona, United States
• Eclipse Clinical Research- Site Number : 8401158 — Tucson, Arizona, United States
• Johnson Dermatology- Site Number : 8401076 — Fort Smith, Arkansas, United States
• Encino Research Center- Site Number : 8401042 — Encino, California, United States
• First OC Dermatology- Site Number : 8401025 — Fountain Valley, California, United States
• Center for Dermatology Clinical Research- Site Number : 8401018 — Fremont, California, United States
• Marvel Clinical Research- Site Number : 8401102 — Huntington Beach, California, United States
• Sunwise Clinical Research- Site Number : 8401022 — Lafayette, California, United States
• Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027 — Lomita, California, United States
• Dermatology Research Associates - Los Angeles- Site Number : 8401092 — Los Angeles, California, United States
• LA Universal Research Center- Site Number : 8401064 — Los Angeles, California, United States
• Northridge Clinical Trials - Northridge- Site Number : 8401080 — Northridge, California, United States
• Cura Clinical Research - Oxnard- Site Number : 8401142 — Oxnard, California, United States
• Southern California Dermatology- Site Number : 8401043 — Santa Ana, California, United States
• Clinical Science Institute- Site Number : 8401028 — Santa Monica, California, United States
• UConn Health - Farmington- Site Number : 8401115 — Farmington, Connecticut, United States
• Pediatric Skin Research- Site Number : 8401198 — Coral Gables, Florida, United States
• St. Jude Clinical Research- Site Number : 8401287 — Doral, Florida, United States
• Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286 — Fort Myers, Florida, United States
• Direct Helpers Research Center- Site Number : 8401056 — Hialeah, Florida, United States
• Encore Medical Research - Hollywood- Site Number : 8401030 — Hollywood, Florida, United States
• Clever Medical Research- Site Number : 8401160 — Miami, Florida, United States
• Acevedo Clinical Research Associates- Site Number : 8401088 — Miami, Florida, United States
• Cahaba Dermatology & Skin Health Center- Site Number : 8401066 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.