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NCT06224348

PHASE3

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI. 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).

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

643

Start Date

2024-01-18

Completion Date

2025-11-01

Last Updated

2026-08-13

Healthy Volunteers

Conditions

Dermatitis Atopic

Interventions

DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: SC injection

DRUG

Placebo

Pharmaceutical form: injection solution Route of administration: SC injection

DRUG

Topical corticosteroids

Pharmaceutical form: Topical formulation Route of administration: Topical

DRUG

Topical calcineurin inhibitors

Pharmaceutical form: Topical formulation Route of administration: Topical

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 inadequate response 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: Participants are excluded from the study if any of the following criteria apply: * 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 * 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

Locations (167)

Cahaba Dermatology & Skin Health Center- Site Number : 8401066

Birmingham, Alabama, United States

Johnson Dermatology- Site Number : 8401076

Fort Smith, Arkansas, United States

Encino Research Center- Site Number : 8401042

Encino, California, United States

Marvel Clinical Research- Site Number : 8401102

Huntington Beach, California, United States

LA Universal Research Center- Site Number : 8401064

Los Angeles, California, United States

Cura Clinical Research- Site Number : 8401141

Palmdale, California, United States

Integrative Skin Science and Research- Site Number : 8401275

Sacramento, California, United States

Southern California Dermatology- Site Number : 8401043

Santa Ana, California, United States

Skin Care Research - Hollywood- Site Number : 8401071

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

Palm Springs Community Health Center- Site Number : 8401264

Miami Lakes, Florida, United States

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, United States

University of South Florida- Site Number : 8401070

Tampa, Florida, United States

Avita Clinical Research- Site Number : 8401073

Tampa, Florida, United States

Cleaver Medical Group- Site Number : 8401138

Dawsonville, Georgia, United States

NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038

Skokie, Illinois, United States

Dawes Fretzin Clinical Research- Site Number : 8401015

Indianapolis, Indiana, United States

BRCR Global Gretna- Site Number : 8401243

Gretna, Louisiana, United States

Velocity Clinical Research - New Orleans- Site Number : 8401155

New Orleans, Louisiana, 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

Dermatology and Skin Cancer Lee's Summit- Site Number : 8401157

Lee's Summit, Missouri, United States

Skin Specialists- Site Number : 8401068

Omaha, Nebraska, United States

Jubilee Clinical Research- Site Number : 8401054

Las Vegas, Nevada, United States

Allcutis Research - Portsmouth- Site Number : 8401082

Portsmouth, New Hampshire, 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

OptiSkin- Site Number : 8401163

New York, New York, United States

Apex Clinical Research Center- Site Number : 8401237

Mayfield Heights, Ohio, United States

Essential Medical Research- Site Number : 8401183

Tulsa, Oklahoma, United States

Vial Health - DermDox Dermatology- Site Number : 8401031

Camp Hill, Pennsylvania, United States

Clinical Research Center of the Carolinas- Site Number : 8401067

Charleston, South Carolina, United States

SMS Clinical Research- Site Number : 8401182

Mesquite, Texas, United States

Sienna Dermatology- Site Number : 8401148

Missouri City, Texas, United States

Texas Dermatology and Laser Specialists- Site Number : 8401131

San Antonio, Texas, United States

Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026

San Antonio, Texas, United States

Complete Dermatology - Sugar Land- Site Number : 8401061

Sugar Land, Texas, United States

Cope Family Medicine - Ogden Clinic- Site Number : 8401114

Bountiful, Utah, United States

Tanner Clinic - Layton Antelope A- Site Number : 8401151

Layton, Utah, United States

Investigational Site Number : 0320005

CABA, Buenos Aires F.D., Argentina

Investigational Site Number : 0320011

Buenos Aires, Argentina

Investigational Site Number : 0320019

Buenos Aires, Argentina

Investigational Site Number : 0320008

Buenos Aires, Argentina

Investigational Site Number : 0320018

Buenos Aires, Argentina

Investigational Site Number : 0320010

Buenos Aires, Argentina

Investigational Site Number : 0320004

Buenos Aires, Argentina

Investigational Site Number : 0320012

Corrientes, Argentina

Investigational Site Number : 0320013

Mendoza, Argentina

Investigational Site Number : 0320020

San Miguel de Tucumán, Argentina

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

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, Brazil

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

São Paulo, Brazil

Hospital das Clinicas FMUSP- Site Number : 0760012

São Paulo, Brazil

Investigational Site Number : 1002007

Dupnitsa, Bulgaria

Investigational Site Number : 1002004

Pleven, Bulgaria

Investigational Site Number : 1002009

Sofia, Bulgaria

Investigational Site Number : 1002006

Sofia, Bulgaria

Investigational Site Number : 1240039

Calgary, Alberta, Canada

Investigational Site Number : 1240045

Red Deer, Alberta, Canada

Investigational Site Number : 1240046

Kamloops, British Columbia, Canada

Investigational Site Number : 1240030

Surrey, British Columbia, Canada

Investigational Site Number : 1240041

Winnipeg, Manitoba, Canada

Investigational Site Number : 1240057

Brampton, Ontario, Canada

Investigational Site Number : 1241106

Markham, Ontario, Canada

Investigational Site Number : 1240008

Mississauga, Ontario, Canada

Investigational Site Number : 1240004

Peterborough, Ontario, Canada

Investigational Site Number : 1240038

Richmond Hill, Ontario, Canada

Investigational Site Number : 1240012

Toronto, Ontario, Canada

Investigational Site Number : 1241107

Waterloo, Ontario, Canada

Investigational Site Number : 1240006

Québec, Quebec, Canada

Investigational Site Number : 1520009

Osorno, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520008