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NCT06130566

PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

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).

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 Monotherapy 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

601

Start Date

2023-11-08

Completion Date

2025-11-13

Last Updated

2026-07-22

Healthy Volunteers

Conditions

Dermatitis Atopic

Interventions

DRUG

Amlitelimab

Injection solution SC injection

DRUG

Placebo

Injection solution SC injection

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

Locations (148)

Scottsdale Clinical Trials- Site Number : 8401149

Scottsdale, Arizona, 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

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, United States

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

North Hollywood, California, United States

Northridge Clinical Trials - Northridge- Site Number : 8401080

Northridge, California, 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- Site Number : 8401030

Hollywood, Florida, United States

Florida International Research Center- Site Number : 8401091

Miami, Florida, United States

Miami Dermatology and Laser Research- Site Number : 8401086

Miami, Florida, United States

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

Orlando, Florida, United States

Cleaver Medical Group Dermatology- Site Number : 8401139

Cumming, 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

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, United States

MedPharmics - Covington- Site Number : 8401137

Covington, Louisiana, United States

MedPharmics - Lafeyette- Site Number : 8401152

Lafayette, Louisiana, United States

Massachusetts General Hospital- Site Number : 8401192

Boston, Massachusetts, United States

Metro Boston Clinical Partners- Site Number : 8401128

Needham, Massachusetts, United States

Revival Research - Doral- Site Number : 8401012

Dearborn, Michigan, United States

Henry Ford Hospital- Site Number : 8401044

Detroit, Michigan, United States

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

Ridgeland, Mississippi, United States

MediSearch Clinical Trials- Site Number : 8401140

Saint Joseph, Missouri, United States

Somnos Clinical Research- Site Number : 8401203

Lincoln, Nebraska, United States

Universal Dermatology- Site Number : 8401224

Fairport, New York, United States

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

New York, New York, United States

CHEAR Center- Site Number : 8401123

The Bronx, New York, United States

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

Charlotte, North Carolina, United States

Oregon Medical Research Center- Site Number : 8401017

Portland, Oregon, United States

Vial Health - DermDox Dermatology- 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

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

Greenville, South Carolina, United States

Dermatology Treatment and Research Center- Site Number : 8401164

Dallas, Texas, United States

Skin Specialist of Addison- Site Number : 8401208

Dallas, Texas, United States

Texas Dermatology and Laser Specialists- Site Number : 8401131

San Antonio, Texas, United States

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, United States

Springville Dermatology - Springville- Site Number : 8401106

Springville, Utah, United States

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia, United States

Investigational Site Number : 0320023

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320024

SAN Miguel de Tucumã¡n, Tucumán Province, Argentina

Investigational Site Number : 0320022

Buenos Aires, Argentina

Investigational Site Number : 0320010

Buenos Aires, 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 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

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

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, 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 : 1240031

Edmonton, Alberta, Canada

Investigational Site Number : 1240040

Surrey, British Columbia, Canada

Investigational Site Number : 1240033

Ajax, Ontario, Canada

Investigational Site Number : 1240055

Hamilton, Ontario, Canada

Investigational Site Number : 1240029

London, Ontario, Canada

Investigational Site Number : 1241108

Niagara Falls, Ontario, Canada

Investigational Site Number : 1240034

Ottawa, Ontario, Canada

Investigational Site Number : 1240013

Toronto, Ontario, Canada

Investigational Site Number : 1240035

Toronto, Ontario, Canada

Investigational Site Number : 1240043

Saint-Jérôme, Quebec, Canada

Investigational Site Number : 1240028

Regina, Saskatchewan, Canada

Investigational Site Number : 1240036

Saskatoon, Saskatchewan, Canada

Investigational Site Number : 1520009

Osorno, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520008