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NCT06241118PHASE3Recruiting

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

Sanofi

Start Date

2/29/2024

Completion Date

9/29/2028

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).

Eligibility Criteria

Age Range: 12 years to No maximum

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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy. * 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

Interventions

DRUG

Amlitelimab

DRUG

Placebo

DRUG

Topical corticosteroids

DRUG

Topical tacrolimus or pimecrolimus

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Dermatitis Atopic

Locations

University of Alabama at Birmingham- Site Number : 8401267

Birmingham, Alabama 35233

United States

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona 85260

United States

Arkansas Dermatology - North Little Rock- Site Number : 8401244

North Little Rock, Arkansas 72117

United States

Encino Research Center- Site Number : 8401042

Encino, California 91436

United States

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California 94538

United States

Long Beach Clinical Trials- Site Number : 8401188

Long Beach, California 90806

United States

Dermatology Research Associates - Los Angeles- Site Number : 8401092

Los Angeles, California 90045

United States

LA Universal Research Center- Site Number : 8401064

Los Angeles, California 90057

United States

University Dermatology Trials- Site Number : 8401339

Newport Beach, California 92660

United States

Rady Children's Hospital- Site Number : 8401291

San Diego, California 92123

United States

Therapeutics Clinical Research- Site Number : 8401283

San Diego, California 92123

United States

Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245

Wheat Ridge, Colorado 80033

United States

Encore Medical Research of Boynton Beach- Site Number : 8401030

Boynton Beach, Florida 33436

United States

St. Jude Clinical Research- Site Number : 8401287

Doral, Florida 33172

United States

Apex Clinical Research - Jacksonville- Site Number : 8401332

Jacksonville, Florida 32256

United States

Clever Medical Research- Site Number : 8401160

Miami, Florida 33126

United States

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida 33714

United States

Avita Clinical Research- Site Number : 8401073

Tampa, Florida 33613

United States

Northwestern University- Site Number : 8401285

Chicago, Illinois 60611

United States

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

Skokie, Illinois 60077

United States

Dawes Fretzin Clinical Research- Site Number : 8401015

Indianapolis, Indiana 46256

United States

Equity Medical - Bowling Green- Site Number : 8401296

Bowling Green, Kentucky 42104

United States

Tandem Clinical Research - Metairie- Site Number : 8401187

Metairie, Louisiana 70006

United States

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

Ann Arbor, Michigan 48109

United States

MI Skin Center- Site Number : 8401307

Northville, Michigan 48167

United States

Skin Specialists- Site Number : 8401068

Omaha, Nebraska 68144

United States

Schweiger Dermatology Group - East Windsor- Site Number : 8401338

East Windsor, New Jersey 08520

United States

The University of New Mexico- Site Number : 8401263

Albuquerque, New Mexico 87106

United States

Equity Medical- Site Number : 8401239

New York, New York 10023

United States

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

New York, New York 10075

United States

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

Cincinnati, Ohio 45229

United States

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

Portland, Oregon 97239

United States

Paddington Testing Company- Site Number : 8401041

Philadelphia, Pennsylvania 19103

United States

Clinical Research of Philadelphia- Site Number : 8401193

Philadelphia, Pennsylvania 19114

United States

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

Charleston, South Carolina 29425

United States

Arlington Research Center- Site Number : 8401248

Arlington, Texas 76011

United States

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

Bellaire, Texas 77401

United States

Reveal Research Institute - Dallas- Site Number : 8401219

Dallas, Texas 75235

United States

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

Ogden, Utah 84405

United States

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia 23502

United States

North Sound Dermatology- Site Number : 8401280

Mill Creek, Washington 98012

United States

Children's Wisconsin- Site Number : 8401246

Milwaukee, Wisconsin 53226

United States

Cheyenne Skin Clinic- Site Number : 8401234

Cheyenne, Wyoming 82009

United States

Investigational Site Number : 0320007

Rosario, Santa Fe Province 2000

Argentina

Investigational Site Number : 0320011

Buenos Aires, 1035

Argentina

Investigational Site Number : 0320019

Buenos Aires, 1426

Argentina

Investigational Site Number : 0320014

Córdoba, 5000

Argentina

Investigational Site Number : 0360008

Melbourne, Victoria 3002

Australia

Investigational Site Number : 0360006

Melbourne, Victoria 3004

Australia

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia 41820-020

Brazil

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

Porto Alegre, Rio Grande do Sul 90020-090

Brazil

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, São Paulo 09060-650

Brazil

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo 18040-425

Brazil

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

São Paulo, 01323-020

Brazil

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

São Paulo, 04020-060

Brazil

Investigational Site Number : 1240019

Calgary, Alberta T2W 4X9

Canada

Investigational Site Number : 1240016

Edmonton, Alberta T5J 3S9

Canada

Investigational Site Number : 1240058

Burlington, Ontario L7L 6W6

Canada

Investigational Site Number : 1240020

Hamilton, Ontario L8L 3C3

Canada

Investigational Site Number : 1240053

London, Ontario N6A 5R9

Canada

Investigational Site Number : 1240035

Toronto, Ontario M5A 3R6

Canada

Investigational Site Number : 1240054

Toronto, Ontario M5m 3z8

Canada

Investigational Site Number : 1240028

Regina, Saskatchewan S4V 1R9

Canada

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago 7580206

Chile

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago 7640881

Chile

Investigational Site Number : 1520010

Santiago, Reg Metropolitana de Santiago 8330034

Chile

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago 8380465

Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago 8420383

Chile

Investigational Site Number : 1560031

Changchun, 130021

China

Investigational Site Number : 1560057

Chongqing, 400016

China

Investigational Site Number : 1560021

Guangzhou, 510018

China

Investigational Site Number : 1560036

Guangzhou, 510100

China

Investigational Site Number : 1560044

Hangzhou, 310003

China

Investigational Site Number : 1560002

Hangzhou, 310006

China

Investigational Site Number : 1560009

Hangzhou, 310009

China

Investigational Site Number : 1560034

Nanyang, 473014

China

Investigational Site Number : 1560024

Ningbo, 315010

China

Investigational Site Number : 1560035

Ningbo, 315010

China

Investigational Site Number : 1560001

Shanghai, 200040

China

Investigational Site Number : 1560005

Shanghai, 200443

China

Investigational Site Number : 1560041

Shenyang, 110001

China

Investigational Site Number : 1560038

Wuhan, 430030

China

Investigational Site Number : 1560032

Xi'an, 710004

China

Investigational Site Number : 2500011

Bordeaux, 33000

France

Investigational Site Number : 2500014

Clermont-Ferrand, 63100

France

Investigational Site Number : 2500004

Créteil, 94010

France

Investigational Site Number : 2500001

Lille, 59037

France

Investigational Site Number : 2500017

Paris, 75010

France

Investigational Site Number : 2500012

Rouen, 76031

France

Investigational Site Number : 2762203

Berlin, 10117

Germany

Investigational Site Number : 2762202

Blankenfelde-Mahlow, 15831

Germany

Investigational Site Number : 2761001

Dresden, 01307

Germany

Investigational Site Number : 2760022

Frankfurt, 60590

Germany

Investigational Site Number : 2761002

Lübeck, 23562

Germany

Investigational Site Number : 2760019

Witten, 58453

Germany

Investigational Site Number : 3000004

Athens, 124 62

Greece

Investigational Site Number : 3000001

Athens, 16121

Greece

Investigational Site Number : 3000005

Athens, 16121

Greece

Investigational Site Number : 3000002

Thessaloniki, 54643

Greece

Investigational Site Number : 3760005

Beersheba, 8457108

Israel

Investigational Site Number : 3760008

Ramat Gan, 5262100

Israel

Investigational Site Number : 3760007

Tel Aviv, 6423906

Israel

Investigational Site Number : 3800020

Turin, Torino 10126

Italy

Center for Advanced Studies and Technology-Site Number: 3800016

Chieti, 66100

Italy

A.O.U. di Modena -Site Number: 3800021

Modena, 41125

Italy

UOC Clinica Dermatologica - AOU "Luigi Vanvitelli"-Site Number : 3800017

Naples, 80131

Italy

Azienda ospedaliera di Perugia - Ospedale "Santa Maria della Misericordia"-Site Number: 3800015

Perugia, 06129

Italy

Investigational Site Number : 3923113

Yokohama, Kanagawa 221-0825

Japan

Investigational Site Number : 3923109

Habikino, Osaka 583-8588

Japan

Investigational Site Number : 3923110

Sakai, Osaka 593-8324

Japan

Investigational Site Number : 3923106

Mibu, Tochigi 321-0293

Japan

Investigational Site Number : 3920001

Tachikawa, Tokyo 190-0023

Japan

Investigational Site Number : 3920007

Hiroshima, 734-8551

Japan

Investigational Site Number : 4840011

Monterrey, Nuevo León 64460

Mexico

Investigational Site Number : 4840003

Veracruz, 91900

Mexico

Investigational Site Number : 6162417

Wroclaw, Lower Silesian Voivodeship 51-685

Poland

Investigational Site Number : 6160002

Lublin, Lublin Voivodeship 20-363

Poland

Investigational Site Number : 6162411

Warsaw, Masovian Voivodeship 01-142

Poland

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship 02-507

Poland

Investigational Site Number : 6160006

Gdansk, Pomeranian Voivodeship 80-546

Poland

Investigational Site Number : 2500016

Saint-Pierre, 97448

Reunion

Investigational Site Number : 6820001

Riyadh, 12713

Saudi Arabia

Investigational Site Number : 4100002

Ansan-si, Gyeonggi-do 15355

South Korea

Investigational Site Number : 4100014

Seongnam-si, Gyeonggi-do 13620

South Korea

Investigational Site Number : 4100015

Bupyeong-Gu, Incheon-gwangyeoksi 21431

South Korea

Investigational Site Number : 4100007

Seoul, Seoul-teukbyeolsi 03722

South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi 07441

South Korea

Investigational Site Number : 7240002

Badalona, Barcelona [Barcelona] 08916

Spain

Investigational Site Number : 7240017

Majadahonda, Madrid 28222

Spain

Investigational Site Number : 7240020

Seville, Sevilla 41013

Spain

Investigational Site Number : 7242505

Alicante, 03010

Spain

Investigational Site Number : 7242503

Madrid, 28046

Spain

Investigational Site Number : 1583201

Kaohsiung City, 833

Taiwan

Investigational Site Number : 1580001

Taipei, 100

Taiwan

Investigational Site Number : 1580003

Taipei,

Taiwan

Investigational Site Number : 1583203

Taoyuan City, 333

Taiwan

Investigational Site Number : 7920008

Gaziantep, 27310

Turkey (Türkiye)

Investigational Site Number : 7920005

Istanbul, 34093

Turkey (Türkiye)

Investigational Site Number : 7920002

Istanbul, 34098

Turkey (Türkiye)

Investigational Site Number : 7841002

Abu Dhabi, 51900

United Arab Emirates

Investigational Site Number : 7840001

Abu Dhabi, 6222

United Arab Emirates

Investigational Site Number : 7840002

Abu Dhabi,

United Arab Emirates

Investigational Site Number : 8260013

Bristol, Bristol, City of BS2 8HW

United Kingdom

Investigational Site Number : 8260012

Plymouth, Devon PL6 8DH

United Kingdom

Investigational Site Number : 8262603

London, England E11 1NR

United Kingdom

Investigational Site Number : 8260015

London, England SW10 9NH

United Kingdom

Investigational Site Number : 8260003

Portsmouth, Hampshire PO3 6DW

United Kingdom

Investigational Site Number : 8260009

Leeds, North Yorkshire Ls7 4sa

United Kingdom

Investigational Site Number : 8260010

Nottingham, Nottinghamshire NG17 4JL

United Kingdom

Investigational Site Number : 8260008

Liverpool, L7 8XP

United Kingdom