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RECRUITING

NCT06241118

PHASE3

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

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 AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. 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 have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).

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 (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2024-02-29

Completion Date

2026-09-14

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Dermatitis Atopic

Interventions

DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

DRUG

Topical corticosteroids

Pharmaceutical form: Various Topical formulation Route of administration: Topical

DRUG

Topical tacrolimus or pimecrolimus

Pharmaceutical form: Various Topical formulation Route of administration: Topical

Locations (146)

University of Alabama at Birmingham- Site Number : 8401267

Birmingham, Alabama, United States

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, United States

Arkansas Dermatology - North Little Rock- Site Number : 8401244

North Little Rock, Arkansas, United States

Encino Research Center- Site Number : 8401042

Encino, California, United States

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, United States

Long Beach Clinical Trials- Site Number : 8401188

Long Beach, 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

University Dermatology Trials- Site Number : 8401339

Newport Beach, California, United States

Rady Children's Hospital- Site Number : 8401291

San Diego, California, United States

Therapeutics Clinical Research- Site Number : 8401283

San Diego, California, United States

Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245

Wheat Ridge, Colorado, United States

Encore Medical Research of Boynton Beach- Site Number : 8401030

Boynton Beach, Florida, United States

St. Jude Clinical Research- Site Number : 8401287

Doral, Florida, United States

Apex Clinical Research - Jacksonville- Site Number : 8401332

Jacksonville, Florida, United States

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, United States

Avita Clinical Research- Site Number : 8401073

Tampa, Florida, United States

Northwestern University- Site Number : 8401285

Chicago, Illinois, 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

Tandem Clinical Research - Metairie- Site Number : 8401187

Metairie, Louisiana, United States

University of Michigan Health System - Ann Arbor- Site Number : 8401290

Ann Arbor, Michigan, United States

MI Skin Center- Site Number : 8401307

Northville, Michigan, United States

Skin Specialists- Site Number : 8401068

Omaha, Nebraska, United States

Schweiger Dermatology Group - East Windsor- Site Number : 8401338

East Windsor, 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

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

New York, New York, United States

Cincinnati Children's Hospital Medical Center- Site Number : 8401279

Cincinnati, Ohio, United States

Oregon Health & Science University (OHSU)- Site Number : 8401247

Portland, Oregon, United States

Paddington Testing Company- Site Number : 8401041

Philadelphia, Pennsylvania, United States

Clinical Research of Philadelphia- Site Number : 8401193

Philadelphia, Pennsylvania, United States

Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282

Charleston, South Carolina, United States

Arlington Research Center- Site Number : 8401248

Arlington, Texas, United States

McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288

Bellaire, Texas, United States

Reveal Research Institute - Dallas- Site Number : 8401219

Dallas, Texas, United States

Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057

Ogden, Utah, United States

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia, United States

North Sound Dermatology- Site Number : 8401280

Mill Creek, Washington, United States

Children's Wisconsin- Site Number : 8401246

Milwaukee, Wisconsin, United States

Cheyenne Skin Clinic- Site Number : 8401234

Cheyenne, Wyoming, United States

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320011

Buenos Aires, Argentina

Investigational Site Number : 0320019

Buenos Aires, Argentina

Investigational Site Number : 0320014

Córdoba, Argentina

Investigational Site Number : 0360008

Melbourne, Victoria, Australia

Investigational Site Number : 0360006

Melbourne, Victoria, Australia

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, Brazil

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

Porto Alegre, Rio Grande do Sul, 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

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

Investigational Site Number : 1240019

Calgary, Alberta, Canada

Investigational Site Number : 1240016

Edmonton, Alberta, Canada

Investigational Site Number : 1240058

Burlington, Ontario, Canada

Investigational Site Number : 1240020

Hamilton, Ontario, Canada

Investigational Site Number : 1240053

London, Ontario, Canada

Investigational Site Number : 1240054

Toronto, Ontario, Canada

Investigational Site Number : 1240028

Regina, Saskatchewan, Canada

Investigational Site Number : 1520002