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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

NCT06407934 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1541

Last updated 2026-04-20

No results posted yet for this study

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).

Conditions

  • Dermatitis Atopic

Interventions

DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: SC injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-08
Primary Completion
2026-06-29
Completion
2027-03-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06407934 on ClinicalTrials.gov