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Monoclonal Antibodies

Amlitelimab for Eczema (ESTUARY Trial)

Phase 3
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight must be ≥ 25 kg
Participants must be at least 12 years of age inclusive, at the time the informed consent is signed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
Pivotal Trial

Summary

This trial is a Phase 3 study for treating moderate-to-severe atopic dermatitis in participants aged 12 years and older. The study aims to see if participants who responded well to aml

Who is the study for?
This trial is for people aged 12 and older with moderate-to-severe atopic dermatitis, who responded well to a previous amlitelimab study. Participants must have been part of earlier COAST or SHORE studies and shown improvement.
What is being tested?
The trial tests two different doses of the drug amlitelimab against no treatment (placebo) to see if it helps maintain skin condition improvements in participants. It's randomized, double-blind, and lasts up to 64 weeks with around 14 visits.
What are the potential side effects?
Possible side effects of amlitelimab may include reactions at the injection site, common cold symptoms, headache, and eye inflammation. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body weight is at least 25 kg.
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I am 12 years old or older.
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I completed a 24-week study for moderate-to-severe AD without stopping the medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants who maintain clinical response at Week 48 of ESTUARY.
Secondary study objectives
Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline
Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline
Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline
+64 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Amlitelimab dose 2Experimental Treatment1 Intervention
Subcutaneous injection as per protocol
Group II: Amlitelimab dose 1Experimental Treatment1 Intervention
Subcutaneous injection as per protocol
Group III: PlaceboPlacebo Group1 Intervention
Subcutaneous injection as per protocol

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,209 Previous Clinical Trials
4,038,805 Total Patients Enrolled
43 Trials studying Eczema
16,023 Patients Enrolled for Eczema
~641 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
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