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

Conditions

• Dermatitis Atopic

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amlitelimab — DRUG
  Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection
• Placebo — DRUG
  Pharmaceutical form: Injection solution Route of administration: SC injection

Study Details

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 Dates

Start date

May 8, 2024

Status verified

Apr 2026

Primary completion

Jun 29, 2026

Completion

Mar 17, 2027

Study Design

Enrollment

1,541 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Amlitelimab dose 1
  Subcutaneous injection as per protocol
• Experimental: Amlitelimab dose 2
  Subcutaneous injection as per protocol
• Placebo Comparator: Placebo
  Subcutaneous injection as per protocol

Primary Outcome Measure

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 [ Time Frame: Week 24 ]

Locations (82)

Find similar trials in Birmingham, AL

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