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ACTIVE NOT RECRUITING

NCT06407934

PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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).

Official title: A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1541

Start Date

2024-05-08

Completion Date

2027-03-17

Last Updated

2026-04-20

Healthy Volunteers

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

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 before or at the time of the planned first dose in the EFC17600 (ESTUARY) study. * Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.). * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (326)

Cahaba Dermatology & Skin Health Center- Site Number : 8401066

Birmingham, Alabama, United States

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, United States

Scottsdale Clinical Trials- Site Number : 8401149

Scottsdale, Arizona, United States

Eclipse Clinical Research- Site Number : 8401158

Tucson, Arizona, United States

Johnson Dermatology- Site Number : 8401076

Fort Smith, Arkansas, United States

Encino Research Center- Site Number : 8401042

Encino, California, United States

First OC Dermatology- Site Number : 8401025

Fountain Valley, California, United States

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, United States

Marvel Clinical Research- Site Number : 8401102

Huntington Beach, California, United States

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, United States

Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027

Lomita, California, United States

Dermatology Research Associates - Los Angeles- Site Number : 8401092

Los Angeles, California, United States

LA Universal Research Center- Site Number : 8401064

Los Angeles, California, United States

Northridge Clinical Trials - Northridge- Site Number : 8401080

Northridge, California, United States

Cura Clinical Research - Oxnard- Site Number : 8401142

Oxnard, California, United States

Southern California Dermatology- Site Number : 8401043

Santa Ana, California, United States

Clinical Science Institute- Site Number : 8401028

Santa Monica, California, United States

UConn Health - Farmington- Site Number : 8401115

Farmington, Connecticut, United States

Pediatric Skin Research- Site Number : 8401198

Coral Gables, Florida, United States

St. Jude Clinical Research- Site Number : 8401287

Doral, Florida, United States

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

Fort Myers, Florida, United States

Direct Helpers Research Center- Site Number : 8401056

Hialeah, Florida, United States

Encore Medical Research - Hollywood- Site Number : 8401030

Hollywood, Florida, United States

Clever Medical Research- Site Number : 8401160

Miami, Florida, United States

Acevedo Clinical Research Associates- Site Number : 8401088

Miami, Florida, United States

Florida International Research Center- Site Number : 8401091

Miami, Florida, United States

Miami Dermatology and Laser Research - Miami - Southwest 87th Avenue- Site Number : 8401086

Miami, Florida, United States

Anchor Medical Research- Site Number : 8401300

Miami, Florida, United States

Savin Medical Group - Miami Lakes- Site Number : 8401085

Miami Lakes, Florida, United States

Nuline Clinical Trial Center- Site Number : 8401161

Pompano Beach, Florida, United States

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, United States

Clinical Research Trials of Florida- Site Number : 8401023

Tampa, Florida, United States

AllerVie Clinical Research - Columbus- Site Number : 8401104

Columbus, Georgia, United States

Cleaver Medical Group- Site Number : 8401138

Dawsonville, Georgia, United States

First Georgia Physician Group- Site Number : 8401190

Fayetteville, Georgia, United States

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

Macon, Georgia, United States

Javara Research - Thomasville- Site Number : 8401189

Thomasville, Georgia, United States

Rophe Adult & Pediatric Medicine- Site Number : 8401289

Union City, Georgia, United States

NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038

Skokie, Illinois, United States

Dawes Fretzin Clinical Research- Site Number : 8401015

Indianapolis, Indiana, United States

Equity Medical - Bowling Green- Site Number : 8401296

Bowling Green, Kentucky, United States

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, United States

MedPharmics - Covington- Site Number : 8401137

Covington, Louisiana, United States

BRCR Global Gretna- Site Number : 8401243

Gretna, Louisiana, United States

Velocity Clinical Research - Lafayette- Site Number : 8401152

Lafayette, Louisiana, United States

MetroBoston Clinical Partners - Brighton- Site Number : 8401128

Brighton, Massachusetts, United States

Henry Ford Hospital- Site Number : 8401044

Detroit, Michigan, United States

Revival Research Institute - Troy- Site Number : 8401012

Troy, Michigan, United States

Oakland Medical Center- Site Number : 8401116

Troy, Michigan, United States

Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078

Ypsilanti, Michigan, United States

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

Ridgeland, Mississippi, United States

Skin Specialists- Site Number : 8401068

Omaha, Nebraska, United States

Jubilee Clinical Research- Site Number : 8401054

Las Vegas, Nevada, United States

Care Access - Hoboken- Site Number : 8401132

Hoboken, New Jersey, United States

The University of New Mexico- Site Number : 8401263

Albuquerque, New Mexico, United States

Equity Medical- Site Number : 8401239

New York, New York, United States

Icahn School of Medicine at Mount Sinai- Site Number : 8401129

New York, New York, United States

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

New York, New York, United States

OptiSkin- Site Number : 8401163

New York, New York, United States

AXIS Clinicals - Fargo- Site Number : 8401196

Fargo, North Dakota, United States

Bexley Dermatology Research- Site Number : 8401051

Bexley, Ohio, United States

Apex Clinical Research Center- Site Number : 8401237

Mayfield Heights, Ohio, United States

Oregon Medical Research Center- Site Number : 8401017

Portland, Oregon, United States

Best Skin Research - Camp Hill- Site Number : 8401031

Camp Hill, Pennsylvania, United States

Paddington Testing Company- Site Number : 8401041

Philadelphia, Pennsylvania, United States

Clinical Research of Philadelphia- Site Number : 8401193

Philadelphia, Pennsylvania, United States

Dermatology Associates of Plymouth Meeting- Site Number : 8401147

Plymouth Meeting, Pennsylvania, United States

Columbia Dermatology & Aesthetics- Site Number : 8401166

Columbia, South Carolina, United States

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

Greenville, South Carolina, United States

Health Concepts- Site Number : 8401059

Rapid City, South Dakota, United States

Arlington Research Center- Site Number : 8401248

Arlington, Texas, United States

Dermatology Treatment and Research Center- Site Number : 8401164

Dallas, Texas, United States

Derm Texas- Site Number : 8401217

Dallas, Texas, United States

Prolato Clinical Research Center- Site Number : 8401209

Houston, Texas, United States

SMS Clinical Research- Site Number : 8401182

Mesquite, Texas, United States

Synapse Clinical Research - Missouri City- Site Number : 8401148

Missouri City, Texas, United States

Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8401131

San Antonio, Texas, United States

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, United States

Complete Dermatology - Sugar Land- Site Number : 8401061

Sugar Land, Texas, United States

Tanner Clinic - Layton Antelope A- Site Number : 8401151

Layton, Utah, United States

Care Access - Arlington- Site Number : 8401134

Arlington, Virginia, United States

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia, United States

Investigational Site Number : 0320021

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320017

Pilar, Buenos Aires, Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320015

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320024

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320020

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320022

Buenos Aires, Argentina

Investigational Site Number : 0320023

Buenos Aires, Argentina

Investigational Site Number : 0320011

Buenos Aires, Argentina

Investigational Site Number : 0320016

Buenos Aires, Argentina

Investigational Site Number : 0320008

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320018

Buenos Aires, Argentina

Investigational Site Number : 0320010

Buenos Aires, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320004

Buenos Aires, Argentina

Investigational Site Number : 0320009

Buenos Aires, Argentina

Investigational Site Number : 0320019

Buenos Aires, Argentina

Investigational Site Number : 0320005

Buenos Aires, Argentina

Investigational Site Number : 0320012

Corrientes, Argentina

Investigational Site Number : 0320013

Mendoza, Argentina

Investigational Site Number : 0360010

Westmead, New South Wales, Australia

Investigational Site Number : 0360007

Woolloongabba, Queensland, Australia

Investigational Site Number : 0360008

Melbourne, Victoria, Australia

Investigational Site Number : 0360006

Melbourne, Victoria, Australia

Investigational Site Number : 0361006

Traralgon, Victoria, Australia

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017

Vitória, Espírito Santo, Brazil

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, Brazil

Hospital São Domingos- Site Number : 0760028

Bequimão, Maranhão, Brazil

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

Curitiba, Paraná, Brazil

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

Curitiba, Paraná, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015

Ribeirão Preto, São Paulo, Brazil

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, São Paulo, Brazil

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo, Brazil

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

Rio de Janeiro, Brazil

Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010

São Paulo, Brazil

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

São Paulo, Brazil

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

São Paulo, Brazil

Investigational Site Number : 1002007

Dupnitsa, Bulgaria

Investigational Site Number : 1002004

Pleven, Bulgaria

Investigational Site Number : 1002005

Sofia, Bulgaria

Investigational Site Number : 1240039

Calgary, Alberta, Canada

Investigational Site Number : 1240031

Edmonton, Alberta, Canada

Investigational Site Number : 1240045

Red Deer, Alberta, Canada

Investigational Site Number : 1240046

Kelowna, British Columbia, Canada

Investigational Site Number : 1240040

Surrey, British Columbia, Canada

Investigational Site Number : 1240030

Surrey, British Columbia, Canada

Investigational Site Number : 1240041

Winnipeg, Manitoba, Canada

Investigational Site Number : 1240033

Ajax, Ontario, Canada

Investigational Site Number : 1240029

London, Ontario, Canada

Investigational Site Number : 1241106

Markham, Ontario, Canada

Investigational Site Number : 1240008

Mississauga, Ontario, Canada

Investigational Site Number : 1241108

Niagara Falls, Ontario, Canada

Investigational Site Number : 1240034

Ottawa, Ontario, Canada

Investigational Site Number : 1240038

Richmond Hill, Ontario, Canada

Investigational Site Number : 1240012

Toronto, Ontario, Canada

Investigational Site Number : 1240035

Toronto, Ontario, Canada

Investigational Site Number : 1241107

Waterloo, Ontario, Canada

Investigational Site Number : 1240006

Québec, Quebec, Canada

Investigational Site Number : 1240028

Regina, Saskatchewan, Canada

Investigational Site Number : 1240036

Saskatoon, Saskatchewan, Canada

Investigational Site Number : 1520012

Talcahuano, Biobio, Chile

Investigational Site Number : 1520004

Valdivia, Los Ríos Region, Chile

Investigational Site Number : 1520009

Osorno, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520013