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

PHASE3RecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

February 29, 2024

Primary Completion Date

May 25, 2026

Study Completion Date

September 14, 2026

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

Trial Locations (146)

100

RECRUITING

Investigational Site Number : 1580001, Taipei

333

RECRUITING

Investigational Site Number : 1583203, Taoyuan

833

RECRUITING

Investigational Site Number : 1583201, Kaohsiung City

1035

RECRUITING

Investigational Site Number : 0320011, Buenos Aires

1056

RECRUITING

Investigational Site Number : 0320019, Buenos Aires

2000

RECRUITING

Investigational Site Number : 0320007, Rosario

3002

RECRUITING

Investigational Site Number : 0360008, Melbourne

3004

RECRUITING

Investigational Site Number : 0360006, Melbourne

5000

RECRUITING

Investigational Site Number : 0320014, Córdoba

10023

RECRUITING

Equity Medical- Site Number : 8401239, New York

10075

RECRUITING

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

10117

RECRUITING

Investigational Site Number : 2762203, Berlin

10126

RECRUITING

Investigational Site Number : 3800020, Turin

12713

RECRUITING

Investigational Site Number : 6820001, Riyadh

13620

RECRUITING

Investigational Site Number : 4100014, Seongnam-si

15355

RECRUITING

Investigational Site Number : 4100002, Ansan-si

15831

RECRUITING

Investigational Site Number : 2762202, Blankenfelde-Mahlow

19103

RECRUITING

Paddington Testing Company- Site Number : 8401041, Philadelphia

19114

RECRUITING

Clinical Research of Philadelphia- Site Number : 8401193, Philadelphia

21431

RECRUITING

Investigational Site Number : 4100015, Bupyeong-gu

23502

RECRUITING

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047, Norfolk

23538

RECRUITING

Investigational Site Number : 2761002, Lübeck

27310

RECRUITING

Investigational Site Number : 7920008, Gaziantep

28046

RECRUITING

Investigational Site Number : 7242503, Madrid

28222

RECRUITING

Investigational Site Number : 7240017, Majadahonda

28223

RECRUITING

Investigational Site Number : 7240016, Pozuelo de Alarcón

29425

RECRUITING

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

32256

RECRUITING

Apex Clinical Research- Site Number : 8401332, Jacksonville

33000

RECRUITING

Investigational Site Number : 2500011, Bordeaux

33172

RECRUITING

St Jude Clinical Research- Site Number : 8401287, Doral

33436

RECRUITING

Encore Medical Research of Boynton Beach- Site Number : 8401030, Boynton Beach

33613

RECRUITING

Avita Clinical Research- Site Number : 8401073, Tampa

33705

RECRUITING

Global Clinical Professionals (GCP)- Site Number : 8401045, St. Petersburg

34093

RECRUITING

Investigational Site Number : 7920005, Istanbul

34098

RECRUITING

Investigational Site Number : 7920002, Istanbul

35233

RECRUITING

University of Alabama at Birmingham- Site Number : 8401267, Birmingham

41013

RECRUITING

Investigational Site Number : 7240020, Seville

41125

RECRUITING

Investigational Site Number : 3800021, Modena

42134

RECRUITING

Access Dermatology Clinic- Site Number : 8401296, Franklin

46256

RECRUITING

Dawes Fretzin Clinical Research- Site Number : 8401015, Indianapolis

48105

RECRUITING

University of Michigan Medical Center- Site Number : 8401290, Ann Arbor

48167

RECRUITING

MI Skin Center- Site Number : 8401307, Northville

51900

RECRUITING

Investigational Site Number : 7841002, Abu Dhabi

53226

RECRUITING

Children's Wisconsin- Site Number : 8401246, Milwaukee

58453

RECRUITING

Investigational Site Number : 2760019, Witten

59037

RECRUITING

Investigational Site Number : 2500001, Lille

60077

RECRUITING

NorthShore University HealthSystem - Skokie- Site Number : 8401038, Skokie

60611

RECRUITING

Northwestern University- Site Number : 8401285, Chicago

63100

RECRUITING

Investigational Site Number : 2500014, Clermont-Ferrand

64460

RECRUITING

Investigational Site Number : 4840011, Monterrey

66100

RECRUITING

Investigational Site Number : 3800016, Chieti

68144

RECRUITING

Skin Specialists- Site Number : 8401068, Omaha

70006

RECRUITING

Tandem Clinical Research, LLC- Site Number : 8401187, Metairie

72117

RECRUITING

Arkansas Dermatology - North Little Rock- Site Number : 8401244, North Little Rock

75010

RECRUITING

Investigational Site Number : 2500017, Paris

75235

RECRUITING

Reveal Research Institute - Dallas- Site Number : 8401219, Dallas

76011

RECRUITING

Arlington Research Center- Site Number : 8401248, Arlington

76031

RECRUITING

Investigational Site Number : 2500012, Rouen

77401

RECRUITING

The University Of Texas Health Science Center At Houston- Site Number : 8401288, Bellaire

80033

RECRUITING

Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245, Wheat Ridge

80131

RECRUITING

Investigational Site Number : 3800017, Naples

82009

RECRUITING

Cheyenne Skin Clinic- Site Number : 8401234, Cheyenne

84405

RECRUITING

Advanced Research Institute - Odgen- Site Number : 8401057, Ogden

85260

RECRUITING

Center for Dermatology and Plastic Surgery- Site Number : 8401119, Scottsdale

87102

RECRUITING

University of New Mexico Comprehensive Cancer Center- Site Number : 8401263, Albuquerque

90045

RECRUITING

Dermatology Research Associates - Los Angeles- Site Number : 8401092, Los Angeles

90057

RECRUITING

LA Universal Research Center- Site Number : 8401064, Los Angeles

90806

RECRUITING

Long Beach Clinical Trials- Site Number : 8401188, Long Beach

91436

RECRUITING

Encino Research Center- Site Number : 8401042, Encino

91900

RECRUITING

Investigational Site Number : 4840003, Veracruz

92123

RECRUITING

Rady Children's Hospital- Site Number : 8401291, San Diego

RECRUITING

Therapeutics Clinical Research- Site Number : 8401283, San Diego

94010

RECRUITING

Investigational Site Number : 2500004, Créteil

94538

RECRUITING

Center for Dermatology Clinical Research- Site Number : 8401018, Fremont

97239

RECRUITING

Oregon Health and Science University- Site Number : 8401247, Portland

97448

RECRUITING

Investigational Site Number : 2500016, Saint-Pierre

98012

RECRUITING

North Sound Dermatology- Site Number : 8401280, Mill Creek

110001

RECRUITING

Investigational Site Number : 1560041, Shenyang

130021

RECRUITING

Investigational Site Number : 1560031, Changchun

200040

RECRUITING

Investigational Site Number : 1560001, Shanghai

310003

RECRUITING

Investigational Site Number : 1560044, Hangzhou

310006

RECRUITING

Investigational Site Number : 1560002, Hangzhou

310009

RECRUITING

Investigational Site Number : 1560009, Hangzhou

315010

RECRUITING

Investigational Site Number : 1560024, Ningbo

RECRUITING

Investigational Site Number : 1560035, Ningbo

430030

RECRUITING

Investigational Site Number : 1560038, Wuhan

473014

RECRUITING

Investigational Site Number : 1560034, Nanyang

510018

RECRUITING

Investigational Site Number : 1560021, Guangzhou

510100

RECRUITING

Investigational Site Number : 1560036, Guangzhou

710004

RECRUITING

Investigational Site Number : 1560032, Xi'an

5262100

RECRUITING

Investigational Site Number : 3760008, Ramat Gan

6423906

RECRUITING

Investigational Site Number : 3760007, Tel Aviv

7580206

RECRUITING

Investigational Site Number : 1520002, Santiago

7640881

RECRUITING

Investigational Site Number : 1520003, Santiago

8330034

RECRUITING

Investigational Site Number : 1520010, Santiago

8380465

RECRUITING

Investigational Site Number : 1520005, Santiago

8420383

RECRUITING

Investigational Site Number : 1520001, Santiago

8457108

RECRUITING

Investigational Site Number : 3760005, Beersheba

08520

RECRUITING

SDG Dermatology, PC- Site Number : 8401338, East Windsor

41820-020

RECRUITING

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002, Salvador

90020-090

RECRUITING

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

09060-650

RECRUITING

Faculdade de Medicina do ABC- Site Number : 0760001, Santo André

18040-425

ACTIVE_NOT_RECRUITING

Clinica de Alergia Martti Antila- Site Number : 0760006, Sorocaba

01323-020

RECRUITING

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

04020-060

RECRUITING

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

T2W 4X9

RECRUITING

Investigational Site Number : 1240019, Calgary

T5J 3S9

RECRUITING

Investigational Site Number : 1240016, Edmonton

L7L 6W6

RECRUITING

Investigational Site Number : 1240058, Burlington

L8L 3C3

RECRUITING

Investigational Site Number : 1240020, Hamilton

N6A 5R9

RECRUITING

Investigational Site Number : 1240053, London

M5M 3Z8

RECRUITING

Investigational Site Number : 1240054, Toronto

S4V 1R9

RECRUITING

Investigational Site Number : 1240028, Regina

01307

RECRUITING

Investigational Site Number : 2761001, Dresden

124 62

RECRUITING

Investigational Site Number : 3000004, Athens

161 21

RECRUITING

Investigational Site Number : 3000001, Athens

RECRUITING

Investigational Site Number : 3000005, Athens

546 43

RECRUITING

Investigational Site Number : 3000002, Thessaloniki

06156

RECRUITING

Investigational Site Number : 3800015, Perugia

221-0825

RECRUITING

Investigational Site Number : 3923113, Yokohama

583-8588

RECRUITING

Investigational Site Number : 3923109, Habikino

593-8324

RECRUITING

Investigational Site Number : 3923110, Sakai

321-0293

RECRUITING

Investigational Site Number : 3923106, Mibu

190-0023

RECRUITING

Investigational Site Number : 3920001, Tachikawa

734-8551

RECRUITING

Investigational Site Number : 3920007, Hiroshima

3015 CE

RECRUITING

Investigational Site Number : 5280004, Rotterdam

3584 CX

RECRUITING

Investigational Site Number : 5280001, Utrecht

51-685

RECRUITING

Investigational Site Number : 6162417, Wroclaw

20-363

RECRUITING

Investigational Site Number : 6160002, Lublin

01-142

RECRUITING

Investigational Site Number : 6162411, Warsaw

02-507

RECRUITING

Investigational Site Number : 6160001, Warsaw

80-546

RECRUITING

Investigational Site Number : 6160006, Gdansk

03722

RECRUITING

Investigational Site Number : 4100007, Seoul

07441

RECRUITING

Investigational Site Number : 4100001, Seoul

08916

RECRUITING

Investigational Site Number : 7240002, Badalona

03010

RECRUITING

Investigational Site Number : 7242505, Alicante

Unknown

RECRUITING

Investigational Site Number : 1580003, Taipei

RECRUITING

Investigational Site Number : 7840001, Abu Dhabi

RECRUITING

Investigational Site Number : 7840002, Abu Dhabi

BS2 8HW

RECRUITING

Investigational Site Number : 8260013, Bristol

PL6 8DH

RECRUITING

Investigational Site Number : 8260012, Plymouth

E11 1NR

RECRUITING

Investigational Site Number : 8262603, London

SW10 9NH

RECRUITING

Investigational Site Number : 8260015, London

PO3 6DW

RECRUITING

Investigational Site Number : 8260003, Portsmouth

LS7 4SA

RECRUITING

Investigational Site Number : 8260009, Leeds

NG17 4JL

RECRUITING

Investigational Site Number : 8260010, Nottingham

L7 8XP

RECRUITING

Investigational Site Number : 8260008, Liverpool

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT06241118 - 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 | Biotech Hunter | Biotech Hunter