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 (COAST 2)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

589

Participants

Timeline

Start Date

December 21, 2023

Primary Completion Date

November 26, 2025

Study Completion Date

March 17, 2026

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"

Trial Locations (142)

1055

Investigational Site Number : 0320016, Buenos Aires

1121

Investigational Site Number : 0320001, Buenos Aires

1425

Investigational Site Number : 0320002, Buenos Aires

Investigational Site Number : 0320009, Buenos Aires

1431

Investigational Site Number : 1002005, Sofia

1459

Investigational Site Number : 7100004, Boksburg

1500

Investigational Site Number : 7100015, Johannesburg

1629

Investigational Site Number : 0320017, Pilar

1886

Investigational Site Number : 0320021, Berazategui

2000

Investigational Site Number : 0320006, Rosario

Investigational Site Number : 0320007, Rosario

Investigational Site Number : 0320015, Rosario

2196

Investigational Site Number : 7100007, Johannesburg

2730

Investigational Site Number : 2080003, Herlev

3630

Investigational Site Number : 7100012, Durban

4058

Investigational Site Number : 7100001, Durban

5300

Investigational Site Number : 1002008, Gabrovo

5800

Investigational Site Number : 1002004, Pleven

7533

Investigational Site Number : 7100010, Cape Town

7708

Investigational Site Number : 7100009, Cape Town

8200

Investigational Site Number : 2080001, Aarhus

9000

Investigational Site Number : 2080002, Aalborg

10023

Equity Medical- Site Number : 8401239, New York

10467

Montefiore Medical Center - Moses Campus- Site Number : 8401150, The Bronx

11220

OmeraNY- Site Number : 8401156, Brooklyn

15241

PEAK Research- Site Number : 8401083, Upper Saint Clair

18014

Investigational Site Number : 7240018, Granada

19462

Dermatology Associates of Plymouth Meeting- Site Number : 8401147, Plymouth Meeting

20089

Investigational Site Number : 3800018, Rozzano

20127

Investigational Site Number : 4840012, Aguascalientes

21104

Care Access Research - Marriottsville- Site Number : 8401126, Marriottsville

22206

Care Access - Arlington- Site Number : 8401134, Arlington

23666

Velocity Clinical Research - Hampton- Site Number : 8401154, Hampton

28007

Investigational Site Number : 7240029, Madrid

28046

Investigational Site Number : 7242503, Madrid

29212

Columbia Dermatology & Aesthetics- Site Number : 8401166, Columbia

30214

First Georgia Physician Group- Site Number : 8401190, Fayetteville

31904

AllerVie Clinical Research - Columbus- Site Number : 8401104, Columbus

32829

Accel Research - Nona Pediatric Center- Site Number : 8401081, Orlando

33021

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

33060

Nuline Clinical Trial Center- Site Number : 8401161, Pompano Beach

33126

Savin Medical Group - Miami- Site Number : 8401085, Miami

33146

Pediatric Skin Research- Site Number : 8401198, Coral Gables

33176

Anchor Medical Research- Site Number : 8401300, Miami

33343

Investigational Site Number : 7920011, Mersin

33607

Clinical Research Trials of Florida- Site Number : 8401023, Tampa

34000

Investigational Site Number : 4840009, Durango

34093

Investigational Site Number : 7920005, Istanbul

Investigational Site Number : 7920006, Istanbul

34098

Investigational Site Number : 7920002, Istanbul

35010

Investigational Site Number : 7240012, Las Palmas de Gran Canaria

36100

Investigational Site Number : 3800022, Vicenza

38039

Investigational Site Number : 7920004, Kayseri

39216

University Of Mississippi Medical Center- Site Number : 8401184, Jackson

42104

Access Dermatology- Site Number : 8401296, Bowling Green

43209

Bexley Dermatology Research- Site Number : 8401051, Bexley

45246

Velocity Clinical Research - Springdale- Site Number : 8401153, Cincinnati

55139

Investigational Site Number : 7920007, Samsun

56126

Investigational Site Number : 3800008, Pisa

57702

Health Concepts- Site Number : 8401059, Rapid City

58103

Red River Research Partners- Site Number : 8401196, Fargo

64460

Investigational Site Number : 4840011, Monterrey

64718

Investigational Site Number : 4840005, Monterrey

70433

MedPharmics - Covington- Site Number : 8401137, Covington

75235

Derm Texas- Site Number : 8401217, Dallas

76011

Arlington Research Center- Site Number : 8401248, Arlington

77004

Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063, Houston

77054

Prolato Clinical Research Center- Site Number : 8401209, Houston

77459

Sienna Dermatology- Site Number : 8401148, Missouri City

78229

Progressive Clinical Research - San Antonio- Site Number : 8401016, San Antonio

84405

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

85260

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

85745

Eclipse Clinical Research- Site Number : 8401158, Tucson

87102

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

90045

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

90404

Clinical Science Institute- Site Number : 8401028, Santa Monica

90717

Torrance Clinical Research- Site Number : 8401027, Lomita

91900

Investigational Site Number : 4840003, Veracruz

92691

Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079, Mission Viejo

93030

Cura Clinical Research - Oxnard- Site Number : 8401142, Oxnard

95123

Investigational Site Number : 3800009, Catania

100191

Investigational Site Number : 1560004, Beijing

100730

Investigational Site Number : 1560030, Beijing

110179

Investigational Site Number : 1560026, Shenyang

200040

Investigational Site Number : 1560001, Shanghai

200443

Investigational Site Number : 1560005, Shanghai

212000

Investigational Site Number : 1560028, Zhenjiang

214000

Investigational Site Number : 1560003, Wuxi

250013

Investigational Site Number : 1560007, Jinan

310006

Investigational Site Number : 1560002, Hangzhou

310009

Investigational Site Number : 1560006, Hangzhou

310014

Investigational Site Number : 1560029, Hangzhou

315010

Investigational Site Number : 1560024, Ningbo

325035

Investigational Site Number : 1560023, Wenzhou

510018

Investigational Site Number : 1560021, Guangzhou

510080

Investigational Site Number : 1560025, Guangzhou

610041

Investigational Site Number : 1560022, Chengdu

2260877

Investigational Site Number : 1520015, Quillota

5110683

Investigational Site Number : 1520004, Valdivia

7500505

Investigational Site Number : 1520013, Santiago

7640881

Investigational Site Number : 1520003, Santiago

7750495

Investigational Site Number : 1520014, Santiago

06032

University of Connecticut Health Center- Site Number : 8401115, Farmington

02111

Tufts Medical Center Site Number : 8401201, Boston

07030

Care Access - Hoboken- Site Number : 8401132, Hoboken

284 01

Investigational Site Number : 2032106, Kutná Hora

779 00

Investigational Site Number : 2030010, Olomouc

702 00

Investigational Site Number : 2032104, Ostrava

150 00

Investigational Site Number : 2030011, Prague

160 00

Investigational Site Number : 2030006, Prague

00133

Investigational Site Number : 3800013, Rome

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

981-0112

Investigational Site Number : 3920010, Miyagi-gun

981-3133

Investigational Site Number : 3920011, Sendai

583-8588

Investigational Site Number : 3923109, Habikino

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

890-0063

Investigational Site Number : 3923108, Kagoshima

602-8566

Investigational Site Number : 3923102, Kyoto

606-8507

Investigational Site Number : 3920003, Kyoto

1169-050

Investigational Site Number : 6200005, Lisbon

1649-035

Investigational Site Number : 6200004, Lisbon

1998-018

Investigational Site Number : 6200001, Lisbon

4099-001

Investigational Site Number : 6200003, Porto

0009

Investigational Site Number : 7100003, Pretoria

125 44

Investigational Site Number : 7520006, Älvsjö

701 85

Investigational Site Number : 7520001, Örebro

07070

Investigational Site Number : 7920001, Antalya

PO3 6DW

Investigational Site Number : 8260003, Portsmouth

SE1 7EH

Investigational Site Number : 8262602, London

SE1 9RT

Investigational Site Number : 8262601, London

G3 8SJ

Investigational Site Number : 8260006, Glasgow

LE2 0TA

Investigational Site Number : 8260004, Leicester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY