A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlite… (NCT06407934) | Clinical Trial Compass
Active — Not RecruitingPhase 3
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
United States, Argentina, Australia1,541 participantsStarted 2024-05-08
Plain-language summary
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).
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
US and US reference countries: Proportion of participants who are responders AND maintained vIGA-AD ≤2 without experiencing relapse among participants who were responders at baseline of ESTUARY
Timeframe: Week 24
2
EU, EU Reference Countries, and Japan: Proportion of participants who maintain treatment response in ESTUARY without experiencing relapse