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A Study to Evaluate the Effic...

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2025-11-13

Brief Summary

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This is a parallel group, Phase 3, multinational, multicenter, randomized, double blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older.

Study details include:

At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY).

For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up.

For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period.

The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600\] (ESTUARY).

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Detailed Description

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Conditions

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Dermatitis Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Amlitelimab dose 1

Subcutaneous injection as per protocol

Group Type EXPERIMENTAL

Amlitelimab

Intervention Type DRUG

Injection solution SC injection

Amlitelimab dose 2

Subcutaneous injection as per protocol

Group Type EXPERIMENTAL

Amlitelimab

Intervention Type DRUG

Injection solution SC injection

Placebo

Subcutaneous injection as per protocol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Injection solution SC injection

Interventions

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Amlitelimab

Injection solution SC injection

Intervention Type DRUG

Placebo

Injection solution SC injection

Intervention Type DRUG

Other Intervention Names

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SAR445229

Eligibility Criteria

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Inclusion Criteria

* Participants must be 12 years of age (when signing informed consent form)
* Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
* Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
* v-IGA-AD of 3 or 4 at baseline visit
* EASI score of 16 or higher at baseline
* AD involvement of 10% or more of BSA at baseline
* Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
* Able and willing to comply with requested study visits and procedures
* Body weight ≥25 kg

Exclusion Criteria

* Skin co-morbidity that would adversely affect the ability to undertake AD assessments
* Known history of or suspected significant current immunosuppression
* Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \>5 years prior to baseline)
* History of solid organ or stem cell transplant
* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections)
* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
* Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
* In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
* History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Scottsdale Clinical Trials- Site Number : 8401149

Scottsdale, Arizona, United States

Site Status

First OC Dermatology- Site Number : 8401025

Fountain Valley, California, United States

Site Status

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, United States

Site Status

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, United States

Site Status

Carbon Health - North Hollywood - NoHo West- Site Number : 8401218

North Hollywood, California, United States

Site Status

Northridge Clinical Trials - Northridge- Site Number : 8401080

Northridge, California, United States

Site Status

St Jude Clinical Research- Site Number : 8401287

Doral, Florida, United States

Site Status

Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286

Fort Myers, Florida, United States

Site Status

Direct Helpers Research Center- Site Number : 8401056

Hialeah, Florida, United States

Site Status

Encore Medical Research- Site Number : 8401030

Hollywood, Florida, United States

Site Status

Florida International Research Center- Site Number : 8401091

Miami, Florida, United States

Site Status

Miami Dermatology and Laser Research- Site Number : 8401086

Miami, Florida, United States

Site Status

Clinical Neuroscience Solutions - Orlando - South Delaney Avenue- Site Number : 8401035

Orlando, Florida, United States

Site Status

Cleaver Medical Group Dermatology- Site Number : 8401139

Cumming, Georgia, United States

Site Status

Skin Care Physicians of Georgia - Macon- Site Number : 8401034

Macon, Georgia, United States

Site Status

Javara Research - Thomasville- Site Number : 8401189

Thomasville, Georgia, United States

Site Status

Rophe Adult & Pediatric Medicine- Site Number : 8401289

Union City, Georgia, United States

Site Status

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, United States

Site Status

MedPharmics - Covington- Site Number : 8401137

Covington, Louisiana, United States

Site Status

MedPharmics - Lafeyette- Site Number : 8401152

Lafayette, Louisiana, United States

Site Status

Massachusetts General Hospital- Site Number : 8401192

Boston, Massachusetts, United States

Site Status

Metro Boston Clinical Partners- Site Number : 8401128

Needham, Massachusetts, United States

Site Status

Revival Research - Doral- Site Number : 8401012

Dearborn, Michigan, United States

Site Status

Henry Ford Hospital- Site Number : 8401044

Detroit, Michigan, United States

Site Status

SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058

Ridgeland, Mississippi, United States

Site Status

MediSearch Clinical Trials- Site Number : 8401140

Saint Joseph, Missouri, United States

Site Status

Somnos Clinical Research- Site Number : 8401203

Lincoln, Nebraska, United States

Site Status

Universal Dermatology- Site Number : 8401224

Fairport, New York, United States

Site Status

Sadick Research Group - New York - Park Avenue- Site Number : 8401050

New York, New York, United States

Site Status

CHEAR Center- Site Number : 8401123

The Bronx, New York, United States

Site Status

Onsite Clinical Solutions - Charlotte - Blakeney Park Drive- Site Number : 8401124

Charlotte, North Carolina, United States

Site Status

Oregon Medical Research Center- Site Number : 8401017

Portland, Oregon, United States

Site Status

Vial Health - DermDox Dermatology- Site Number : 8401031

Camp Hill, Pennsylvania, United States

Site Status

Paddington Testing Company- Site Number : 8401041

Philadelphia, Pennsylvania, United States

Site Status

Clinical Research of Philadelphia- Site Number : 8401193

Philadelphia, Pennsylvania, United States

Site Status

Tribe Clinical Research - 525 Verdae Boulevard- Site Number : 8401225

Greenville, South Carolina, United States

Site Status

Dermatology Treatment and Research Center- Site Number : 8401164

Dallas, Texas, United States

Site Status

Skin Specialist of Addison- Site Number : 8401208

Dallas, Texas, United States

Site Status

Texas Dermatology and Laser Specialists- Site Number : 8401131

San Antonio, Texas, United States

Site Status

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, United States

Site Status

Springville Dermatology - Springville- Site Number : 8401106

Springville, Utah, United States

Site Status

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia, United States

Site Status

Investigational Site Number : 0320023

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Investigational Site Number : 0320024

SAN Miguel de Tucumã¡n, Tucumán Province, Argentina

Site Status

Investigational Site Number : 0320022

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320010

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0360010

Westmead, New South Wales, Australia

Site Status

Investigational Site Number : 0360007

Woolloongabba, Queensland, Australia

Site Status

Investigational Site Number : 0360008

Melbourne, Victoria, Australia

Site Status

Investigational Site Number : 0360006

Melbourne, Victoria, Australia

Site Status

Investigational Site Number : 0361006

Traralgon, Victoria, Australia

Site Status

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, Brazil

Site Status

Hospital São Domingos- Site Number : 0760028

Bequimão, Maranhão, Brazil

Site Status

Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022

Curitiba, Paraná, Brazil

Site Status

PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023

Curitiba, Paraná, Brazil

Site Status

Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo, Brazil

Site Status

CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018

Rio de Janeiro, , Brazil

Site Status

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, , Brazil

Site Status

Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014

São Paulo, , Brazil

Site Status

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012

São Paulo, , Brazil

Site Status

Investigational Site Number : 1240031

Edmonton, Alberta, Canada

Site Status

Investigational Site Number : 1240040

Surrey, British Columbia, Canada

Site Status

Investigational Site Number : 1240033

Ajax, Ontario, Canada

Site Status

Investigational Site Number : 1240055

Hamilton, Ontario, Canada

Site Status

Investigational Site Number : 1240029

London, Ontario, Canada

Site Status

Investigational Site Number : 1241108

Niagara Falls, Ontario, Canada

Site Status

Investigational Site Number : 1240034

Ottawa, Ontario, Canada

Site Status

Investigational Site Number : 1240013

Toronto, Ontario, Canada

Site Status

Investigational Site Number : 1240035

Toronto, Ontario, Canada

Site Status

Investigational Site Number : 1240043

Saint-Jérôme, Quebec, Canada

Site Status

Investigational Site Number : 1240028

Regina, Saskatchewan, Canada

Site Status

Investigational Site Number : 1240036

Saskatoon, Saskatchewan, Canada

Site Status