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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

601

Participants

Timeline

Start Date

November 8, 2023

Primary Completion Date

July 23, 2025

Study Completion Date

November 12, 2025

Conditions
Dermatitis Atopic
Interventions
DRUG

Amlitelimab

Injection solution SC injection

DRUG

Placebo

Injection solution SC injection

Trial Locations (148)

100

Investigational Site Number : 1580001, Taipei

333

Investigational Site Number : 1583203, Taoyuan

402

Investigational Site Number : 1583202, Taichung

833

Investigational Site Number : 1583201, Kaohsiung City

1012

Investigational Site Number : 0320022, Buenos Aires

1028

Investigational Site Number : 0320023, Buenos Aires

1414

Investigational Site Number : 0320010, Buenos Aires

2145

Investigational Site Number : 0360010, Westmead

3002

Investigational Site Number : 0360008, Melbourne

3004

Investigational Site Number : 0360006, Melbourne

3844

Investigational Site Number : 0361006, Traralgon

4102

Investigational Site Number : 0360007, Woolloongabba

10075

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

10459

CHEAR Center- Site Number : 8401123, The Bronx

13620

Investigational Site Number : 4100014, Seongnam-si

14450

Universal Dermatology- Site Number : 8401224, Fairport

15355

Investigational Site Number : 4100002, Ansan-si

16499

Investigational Site Number : 4100009, Suwon

17011

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

19103

Paddington Testing Company- Site Number : 8401041, Philadelphia

19114

Clinical Research of Philadelphia- Site Number : 8401193, Philadelphia

20095

Investigational Site Number : 2760017, Hamburg

21431

Investigational Site Number : 4100015, Bupyeong-gu

21614

Investigational Site Number : 2760014, Buxtehude

23502

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

24105

Investigational Site Number : 2762208, Kiel

26102

Investigational Site Number : 2500010, Romans-sur-Isère

28277

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

29607

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

30040

Cleaver Medical Group Dermatology- Site Number : 8401139, Cumming

30291

Rophe Adult & Pediatric Medicine- Site Number : 8401289, Union City

31217

Skin Care Physicians of Georgia - Macon- Site Number : 8401034, Macon

31792

Javara Research - Thomasville- Site Number : 8401189, Thomasville

32806

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

33012

Direct Helpers Research Center- Site Number : 8401056, Hialeah

33021

Encore Medical Research- Site Number : 8401030, Hollywood

33122

Revival Research - Doral- Site Number : 8401012, Dearborn

33172

St Jude Clinical Research- Site Number : 8401287, Doral

33173

Florida International Research Center- Site Number : 8401091, Miami

Miami Dermatology and Laser Research- Site Number : 8401086, Miami

33919

Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286, Fort Myers

39104

Investigational Site Number : 2760018, Magdeburg

39157

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

40217

Skin Sciences- Site Number : 8401039, Louisville

41944

Investigational Site Number : 4100008, Daegu

44093

Investigational Site Number : 2500009, Nantes

48149

Investigational Site Number : 2762201, Münster

48202

Henry Ford Hospital- Site Number : 8401044, Detroit

48455

Investigational Site Number : 2760009, Bad Bentheim

50612

Investigational Site Number : 4100003, Yangsan

51100

Investigational Site Number : 2500007, Reims

55128

Investigational Site Number : 2760016, Mainz

61453

Investigational Site Number : 4100012, Gwangju

64506

MediSearch Clinical Trials- Site Number : 8401140, Saint Joseph

68510

Somnos Clinical Research- Site Number : 8401203, Lincoln

70433

MedPharmics - Covington- Site Number : 8401137, Covington

70508

MedPharmics - Lafeyette- Site Number : 8401152, Lafayette

75010

Investigational Site Number : 2500003, Paris

75230

Dermatology Treatment and Research Center- Site Number : 8401164, Dallas

75254

Skin Specialist of Addison- Site Number : 8401208, Dallas

76092

Stryde Research - Epiphany Dermatology- Site Number : 8401185, Southlake

78218

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

84663

Springville Dermatology - Springville- Site Number : 8401106, Springville

85260

Scottsdale Clinical Trials- Site Number : 8401149, Scottsdale

91325

Northridge Clinical Trials - Northridge- Site Number : 8401080, Northridge

91606

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

92160

Investigational Site Number : 2500008, Antony

92708

First OC Dermatology- Site Number : 8401025, Fountain Valley

94538

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

94549

Sunwise Clinical Research- Site Number : 8401022, Lafayette

97201

Oregon Medical Research Center- Site Number : 8401017, Portland

100034

Investigational Site Number : 1560042, Beijing

121002

Investigational Site Number : 3560006, Haryāna

160012

Investigational Site Number : 3560004, Chandigarh

250014

Investigational Site Number : 1560059, Jinan

380016

Investigational Site Number : 3560001, Ahmedabad

400016

Investigational Site Number : 1560057, Chongqing

400065

Investigational Site Number : 1560065, Chongqing

411057

Investigational Site Number : 3560003, Pune

440015

Investigational Site Number : 3560002, Nagpur

510630

Investigational Site Number : 1560058, Guangzhou

518026

Investigational Site Number : 1560064, Shenzhen

560090

Investigational Site Number : 3560008, Bengaluru

590002

Investigational Site Number : 3560005, Belagavi

610072

Investigational Site Number : 1560060, Chengdu

610091

Investigational Site Number : 1560068, Chengdu

700073

Investigational Site Number : 3560007, Kolkata

1834111

Investigational Site Number : 3760004, Afula

2530900

Investigational Site Number : 1520006, Viña del Mar

2687000

Investigational Site Number : 1520012, Talcahuano

3109601

Investigational Site Number : 3760001, Haifa

4920235

Investigational Site Number : 3760006, Petah Tikva

4941492

Investigational Site Number : 3760002, Petah Tikva

5311523

Investigational Site Number : 1520009, Osorno

7500587

Investigational Site Number : 1520008, Santiago

7580206

Investigational Site Number : 1520002, Santiago

7640881

Investigational Site Number : 1520003, Santiago

8330034

Investigational Site Number : 1520010, Santiago

8380456

Investigational Site Number : 1520011, Santiago

8380465

Investigational Site Number : 1520005, Santiago

8420383

Investigational Site Number : 1520001, Santiago

8457108

Investigational Site Number : 3760005, Beersheba

9112001

Investigational Site Number : 3760003, Jerusalem

02114

Massachusetts General Hospital- Site Number : 8401192, Boston

02492

Metro Boston Clinical Partners- Site Number : 8401128, Needham

T4000

Investigational Site Number : 0320024, SAN Miguel de Tucumã¡n

41820-020

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

65060-645

Hospital São Domingos- Site Number : 0760028, Bequimão

80060-900

Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022, Curitiba

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

18040-425

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

22241-180

CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018, Rio de Janeiro

09060-650

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

04020-060

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

05403-000

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012, São Paulo

T5K 2V4

Investigational Site Number : 1240031, Edmonton

V3R 6A7

Investigational Site Number : 1240040, Surrey

L1S 7K8

Investigational Site Number : 1240033, Ajax

L8S 1G5

Investigational Site Number : 1240055, Hamilton

N6A 2C2

Investigational Site Number : 1240029, London

L2H 1H5

Investigational Site Number : 1241108, Niagara Falls

K1H 7X8

Investigational Site Number : 1240034, Ottawa

M3B 3N1

Investigational Site Number : 1240013, Toronto

M5A 3R6

Investigational Site Number : 1240035, Toronto

J7Z 7E2

Investigational Site Number : 1240043, Saint-Jérôme

S4V 1R9

Investigational Site Number : 1240028, Regina

S7K 0H6

Investigational Site Number : 1240036, Saskatoon

124 62

Investigational Site Number : 3000004, Athens

161 21

Investigational Site Number : 3000001, Athens

546 42

Investigational Site Number : 3000002, Thessaloniki

564 29

Investigational Site Number : 3000003, Thessaloniki

80-546

Investigational Site Number : 6160006, Gdansk

40-611

Investigational Site Number : 6160003, Katowice

31-209

Investigational Site Number : 6162406, Krakow

90-265

Investigational Site Number : 6160002, Lodz

20-607

Investigational Site Number : 6160004, Lublin

11-041

Investigational Site Number : 6160011, Olsztyn

33-100

Investigational Site Number : 6160010, Tarnów

02-625

Investigational Site Number : 6160009, Warsaw

02-962

Investigational Site Number : 6160007, Warsaw

01812

Investigational Site Number : 4100010, Seoul

03080

Investigational Site Number : 4100013, Seoul

03722

Investigational Site Number : 4100007, Seoul

05030

Investigational Site Number : 4100006, Seoul

06591

Investigational Site Number : 4100011, Seoul

07804

Investigational Site Number : 4100017, Seoul

Unknown

Investigational Site Number : 1580003, Taipei

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT06130566 - 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 | Biotech Hunter | Biotech Hunter