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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

643

Participants

Timeline

Start Date

January 18, 2024

Primary Completion Date

August 21, 2025

Study Completion Date

December 11, 2025

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

Trial Locations (167)

1035

Investigational Site Number : 0320011, Buenos Aires

1056

Investigational Site Number : 0320019, Buenos Aires

1061

Investigational Site Number : 0320008, Buenos Aires

1178

Investigational Site Number : 0320018, Buenos Aires

1414

Investigational Site Number : 0320010, Buenos Aires

1425

Investigational Site Number : 0320004, Buenos Aires

1427

Investigational Site Number : 0320005, CABA

1431

Investigational Site Number : 1002009, Sofia

1592

Investigational Site Number : 1002006, Sofia

2600

Investigational Site Number : 1002007, Dupnitsa

3400

Investigational Site Number : 0320012, Corrientes

4000

Investigational Site Number : 0320020, San Miguel de Tucumán

5500

Investigational Site Number : 0320013, Mendoza

5800

Investigational Site Number : 1002004, Pleven

10023

Equity Medical- Site Number : 8401239, New York

10029

Icahn School of Medicine at Mount Sinai- Site Number : 8401129, New York

10128

OptiSkin- Site Number : 8401163, New York

17011

Vial Health - DermDox Dermatology- Site Number : 8401031, Camp Hill

18012

Investigational Site Number : 7240019, Granada

20095

Investigational Site Number : 2760017, Hamburg

20122

Investigational Site Number : 3800003, Milan

20354

Investigational Site Number : 2760021, Hamburg

21614

Investigational Site Number : 2760014, Buxtehude

24105

Investigational Site Number : 2762208, Kiel

26102

Investigational Site Number : 2500010, Romans-sur-Isère

27310

Investigational Site Number : 7920008, Gaziantep

28031

Investigational Site Number : 7240013, Madrid

29407

Clinical Research Center of the Carolinas- Site Number : 8401067, Charleston

30534

Cleaver Medical Group- Site Number : 8401138, Dawsonville

31008

Investigational Site Number : 7240015, Pamplona

31059

Investigational Site Number : 2500002, Toulouse

33000

Investigational Site Number : 2500011, Bordeaux

33016

Palm Springs Community Health Center- Site Number : 8401264, Miami Lakes

33021

Skin Care Research - Hollywood- Site Number : 8401071, Hollywood

33126

Clever Medical Research- Site Number : 8401160, Miami

33142

Acevedo Clinical Research Associates- Site Number : 8401088, Miami

33612

University of South Florida- Site Number : 8401070, Tampa

33613

Avita Clinical Research- Site Number : 8401073, Tampa

33705

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

34010

Investigational Site Number : 7920003, Istanbul

34093

Investigational Site Number : 7920005, Istanbul

Investigational Site Number : 7920006, Istanbul

34098

Investigational Site Number : 7920002, Istanbul

34662

Investigational Site Number : 7920009, Istanbul

35244

Cahaba Dermatology & Skin Health Center- Site Number : 8401066, Birmingham

36206

Investigational Site Number : 7240014, Vigo

38039

Investigational Site Number : 7920004, Kayseri

39104

Investigational Site Number : 2760018, Magdeburg

40138

Investigational Site Number : 3800012, Bologna

41013

Investigational Site Number : 7240020, Seville

44093

Investigational Site Number : 2500009, Nantes

44124

Apex Clinical Research Center- Site Number : 8401237, Mayfield Heights

46100

Investigational Site Number : 7240023, Burjassot

46256

Dawes Fretzin Clinical Research- Site Number : 8401015, Indianapolis

46940

Investigational Site Number : 7242502, Manises

48013

Investigational Site Number : 7240008, Bilbao

48085

Oakland Medical Center- Site Number : 8401116, Troy

48149

Investigational Site Number : 2762201, Münster

48197

Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078, Ypsilanti

48455

Investigational Site Number : 2760009, Bad Bentheim

55128

Investigational Site Number : 2760016, Mainz

55139

Investigational Site Number : 7920007, Samsun

56126

Investigational Site Number : 3800008, Pisa

58453

Investigational Site Number : 2760019, Witten

60020

Investigational Site Number : 3800019, Torette

60076

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

64064

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

67100

Investigational Site Number : 3800011, L’Aquila

68144

Skin Specialists- Site Number : 8401068, Omaha

69495

Investigational Site Number : 2500006, Pierre-Bénite

70053

BRCR Global Gretna- Site Number : 8401243, Gretna

70119

Velocity Clinical Research - New Orleans- Site Number : 8401155, New Orleans

72916

Johnson Dermatology- Site Number : 8401076, Fort Smith

74137

Essential Medical Research- Site Number : 8401183, Tulsa

75149

SMS Clinical Research- Site Number : 8401182, Mesquite

76031

Investigational Site Number : 2500012, Rouen

77459

Sienna Dermatology- Site Number : 8401148, Missouri City

77479

Complete Dermatology - Sugar Land- Site Number : 8401061, Sugar Land

78218

Texas Dermatology and Laser Specialists- Site Number : 8401131, San Antonio

78258

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

84010

Cope Family Medicine - Ogden Clinic- Site Number : 8401114, Bountiful

84041

Tanner Clinic - Layton Antelope A- Site Number : 8401151, Layton

86150

Investigational Site Number : 2760020, Augsburg

89106

Jubilee Clinical Research- Site Number : 8401054, Las Vegas

90057

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

91436

Encino Research Center- Site Number : 8401042, Encino

92647

Marvel Clinical Research- Site Number : 8401102, Huntington Beach

92701

Southern California Dermatology- Site Number : 8401043, Santa Ana

93551

Cura Clinical Research- Site Number : 8401141, Palmdale

95815

Integrative Skin Science and Research- Site Number : 8401275, Sacramento

97410

Investigational Site Number : 2500016, Saint-Pierre

110001

Investigational Site Number : 1560041, Shenyang

200443

Investigational Site Number : 1560005, Shanghai

214000

Investigational Site Number : 1560003, Wuxi

300052

Investigational Site Number : 1560047, Tianjin

310003

Investigational Site Number : 1560044, Hangzhou

310009

Investigational Site Number : 1560006, Hangzhou

330001

Investigational Site Number : 1560051, Nanchang

350005

Investigational Site Number : 1560043, Fuzhou

410011

Investigational Site Number : 1560050, Changsha

430022

Investigational Site Number : 1560049, Wuhan

510018

Investigational Site Number : 1560021, Guangzhou

610072

Investigational Site Number : 1560060, Chengdu

2530900

Investigational Site Number : 1520006, Viña del Mar

2687000

Investigational Site Number : 1520012, Talcahuano

5311523

Investigational Site Number : 1520009, Osorno

7500588

Investigational Site Number : 1520008, Santiago

7580206

Investigational Site Number : 1520002, Santiago

7640881

Investigational Site Number : 1520003, Santiago

8330032

Investigational Site Number : 1520010, Santiago

8380456

Investigational Site Number : 1520011, Santiago

8380465

Investigational Site Number : 1520005, Santiago

8420383

Investigational Site Number : 1520001, Santiago

03801

Allcutis Research - Portsmouth- Site Number : 8401082, Portsmouth

29055-450

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017, Vitória

41820-020

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

80230-130

PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023, Curitiba

90020-090

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

90610-000

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024, Porto Alegre

14049-900

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015, Ribeirão Preto

09060-650

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

01323-020

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

05403-000

Hospital das Clinicas FMUSP- Site Number : 0760012, São Paulo

T2J 7E1

Investigational Site Number : 1240039, Calgary

T4P 1K4

Investigational Site Number : 1240045, Red Deer

V1Y 4N7

Investigational Site Number : 1240046, Kamloops

V3V 0C6

Investigational Site Number : 1240030, Surrey

R3M 3Z4

Investigational Site Number : 1240041, Winnipeg

L6Z1Y4

Investigational Site Number : 1240057, Brampton

L3P 1X2

Investigational Site Number : 1241106, Markham

L5H 1G9

Investigational Site Number : 1240008, Mississauga

K9J5K2

Investigational Site Number : 1240004, Peterborough

L4E 4L6

Investigational Site Number : 1240038, Richmond Hill

M3H 5Y8

Investigational Site Number : 1240012, Toronto

N2J 1C4

Investigational Site Number : 1241107, Waterloo

G1W 4R4

Investigational Site Number : 1240006, Québec

741 01

Investigational Site Number : 2032105, Nový Jičín

779 00

Investigational Site Number : 2030010, Olomouc

702 00

Investigational Site Number : 2032104, Ostrava

323 00

Investigational Site Number : 2030009, Pilsen

110 00

Investigational Site Number : 2030008, Prague

110 01

Investigational Site Number : 2030008, Prague

150 00

Investigational Site Number : 2030011, Prague

06202

Investigational Site Number : 2500013, Nice

066-0021

Investigational Site Number : 3920009, Chitose

080-0013

Investigational Site Number : 3923114, Obihiro

064-0921

Investigational Site Number : 3920008, Sapporo

653-0836

Investigational Site Number : 3920006, Kobe

252-0315

Investigational Site Number : 3920005, Sagamihara

221-0825

Investigational Site Number : 3923113, Yokohama

Investigational Site Number : 3923113, Yokohama

981-0112

Investigational Site Number : 3920010, Miyagi-gun

981-3133

Investigational Site Number : 3920011, Sendai

593-8324

Investigational Site Number : 3923110, Sakai

350-0495

Investigational Site Number : 3920002, Iruma

321-0293

Investigational Site Number : 3923106, Mibu

104-0031

Investigational Site Number : 3920004, Chūō

108-0014

Investigational Site Number : 3923107, Minato

190-0023

Investigational Site Number : 3920001, Tachikawa

583-8588

Investigational Site Number : 3923109, Habikino

890-0063

Investigational Site Number : 3923108, Kagoshima

602-8566

Investigational Site Number : 3923102, Kyoto

606-8507

Investigational Site Number : 3920003, Kyoto

08950

Investigational Site Number : 7240010, Esplugues de Llobregat

03010

Investigational Site Number : 7242505, Alicante

06560

Investigational Site Number : 7920010, Ankara

07070

Investigational Site Number : 7920001, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY