AzTrials
AzTrials

Dermatitis AtopicPhase 3ESTUARYNCT06407934

A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

A Phase 3 study testing Amlitelimab in people with Dermatitis Atopic, run by Sanofi at 324 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Dermatitis Atopic
What is being tested?
Amlitelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,541 participants
Where
324 sitesin 27 countries
Study dates
8 May 2024to 17 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
  • Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
  • Able and willing to comply with requested study visit and procedures.
  • Body weight must be ≥ 25 kg.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Developed a medical condition that would preclude participation as described in Exclusion Criteria or Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.
  • Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
  • Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
  • Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
  • Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
  • Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

324 sites in 27 countries.

324 sites in 27 countries

United States82 sites

  • The University of New Mexico- Site Number : 8401263

    Albuquerque, New Mexico, 87106

  • Arlington Research Center- Site Number : 8401248

    Arlington, Texas, 76011

  • Care Access - Arlington- Site Number : 8401134

    Arlington, Virginia, 22206

  • Bexley Dermatology Research- Site Number : 8401051

    Bexley, Ohio, 43209

  • Cahaba Dermatology & Skin Health Center- Site Number : 8401066

    Birmingham, Alabama, 35244

  • Equity Medical - Bowling Green- Site Number : 8401296

    Bowling Green, Kentucky, 42104

  • MetroBoston Clinical Partners - Brighton- Site Number : 8401128

    Brighton, Massachusetts, 02135

  • Best Skin Research - Camp Hill- Site Number : 8401031

    Camp Hill, Pennsylvania, 17011

  • Columbia Dermatology & Aesthetics- Site Number : 8401166

    Columbia, South Carolina, 29212

  • AllerVie Clinical Research - Columbus- Site Number : 8401104

    Columbus, Georgia, 31904

  • Pediatric Skin Research- Site Number : 8401198

    Coral Gables, Florida, 33146

  • MedPharmics - Covington- Site Number : 8401137

    Covington, Louisiana, 70433

  • Dermatology Treatment and Research Center- Site Number : 8401164

    Dallas, Texas, 75230

  • Derm Texas- Site Number : 8401217

    Dallas, Texas, 75235

  • Cleaver Medical Group- Site Number : 8401138

    Dawsonville, Georgia, 30534

  • Henry Ford Hospital- Site Number : 8401044

    Detroit, Michigan, 48202

  • St. Jude Clinical Research- Site Number : 8401287

    Doral, Florida, 33172

  • Encino Research Center- Site Number : 8401042

    Encino, California, 91436

  • AXIS Clinicals - Fargo- Site Number : 8401196

    Fargo, North Dakota, 58103

  • UConn Health - Farmington- Site Number : 8401115

    Farmington, Connecticut, 06030

  • First Georgia Physician Group- Site Number : 8401190

    Fayetteville, Georgia, 30214

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

    Fort Myers, Florida, 33919

  • Johnson Dermatology- Site Number : 8401076

    Fort Smith, Arkansas, 72916

  • First OC Dermatology- Site Number : 8401025

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research- Site Number : 8401018

    Fremont, California, 94538

  • Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8401225

    Greenville, South Carolina, 29607

  • BRCR Global Gretna- Site Number : 8401243

    Gretna, Louisiana, 70053

  • Direct Helpers Research Center- Site Number : 8401056

    Hialeah, Florida, 33012

  • Care Access - Hoboken- Site Number : 8401132

    Hoboken, New Jersey, 07030

  • Encore Medical Research - Hollywood- Site Number : 8401030

    Hollywood, Florida, 33024

  • Prolato Clinical Research Center- Site Number : 8401209

    Houston, Texas, 77054

  • Marvel Clinical Research- Site Number : 8401102

    Huntington Beach, California, 92647

  • Dawes Fretzin Clinical Research- Site Number : 8401015

    Indianapolis, Indiana, 46256

  • Sunwise Clinical Research- Site Number : 8401022

    Lafayette, California, 94549

  • Velocity Clinical Research - Lafayette- Site Number : 8401152

    Lafayette, Louisiana, 70508

  • Jubilee Clinical Research- Site Number : 8401054

    Las Vegas, Nevada, 89106

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

    Layton, Utah, 84041

  • Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027

    Lomita, California, 90717

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

    Los Angeles, California, 90045

  • LA Universal Research Center- Site Number : 8401064

    Los Angeles, California, 90057

  • Skin Sciences- Site Number : 8401039

    Louisville, Kentucky, 40217

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

    Macon, Georgia, 31217

  • Apex Clinical Research Center- Site Number : 8401237

    Mayfield Heights, Ohio, 44124

  • SMS Clinical Research- Site Number : 8401182

    Mesquite, Texas, 75149

  • Clever Medical Research- Site Number : 8401160

    Miami, Florida, 33126

  • Acevedo Clinical Research Associates- Site Number : 8401088

    Miami, Florida, 33142

  • Florida International Research Center- Site Number : 8401091

    Miami, Florida, 33173

  • Miami Dermatology and Laser Research - Miami - Southwest 87th Avenue- Site Number : 8401086

    Miami, Florida, 33173

  • Anchor Medical Research- Site Number : 8401300

    Miami, Florida, 33176

  • Savin Medical Group - Miami Lakes- Site Number : 8401085

    Miami Lakes, Florida, 33014

  • Synapse Clinical Research - Missouri City- Site Number : 8401148

    Missouri City, Texas, 77459

  • Equity Medical- Site Number : 8401239

    New York, New York, 10023

  • Icahn School of Medicine at Mount Sinai- Site Number : 8401129

    New York, New York, 10029

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

    New York, New York, 10075

  • OptiSkin- Site Number : 8401163

    New York, New York, 10128

  • Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

    Norfolk, Virginia, 23502

  • Northridge Clinical Trials - Northridge- Site Number : 8401080

    Northridge, California, 91325

  • Skin Specialists- Site Number : 8401068

    Omaha, Nebraska, 68144

  • Cura Clinical Research - Oxnard- Site Number : 8401142

    Oxnard, California, 93030

  • Paddington Testing Company- Site Number : 8401041

    Philadelphia, Pennsylvania, 19103

  • Clinical Research of Philadelphia- Site Number : 8401193

    Philadelphia, Pennsylvania, 19114

  • Dermatology Associates of Plymouth Meeting- Site Number : 8401147

    Plymouth Meeting, Pennsylvania, 19462

  • Nuline Clinical Trial Center- Site Number : 8401161

    Pompano Beach, Florida, 33060

  • Oregon Medical Research Center- Site Number : 8401017

    Portland, Oregon, 97201

  • Health Concepts- Site Number : 8401059

    Rapid City, South Dakota, 57702

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

    Ridgeland, Mississippi, 39157

  • Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8401131

    San Antonio, Texas, 78218

  • Southern California Dermatology- Site Number : 8401043

    Santa Ana, California, 92701

  • Clinical Science Institute- Site Number : 8401028

    Santa Monica, California, 90404

  • Center for Dermatology and Plastic Surgery- Site Number : 8401119

    Scottsdale, Arizona, 85260

  • Scottsdale Clinical Trials- Site Number : 8401149

    Scottsdale, Arizona, 85260

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

    Skokie, Illinois, 60077

  • Stryde Research - Epiphany Dermatology- Site Number : 8401185

    Southlake, Texas, 76092

  • Global Clinical Professionals (GCP)- Site Number : 8401045

    St. Petersburg, Florida, 33705

  • Complete Dermatology - Sugar Land- Site Number : 8401061

    Sugar Land, Texas, 77479

  • Clinical Research Trials of Florida- Site Number : 8401023

    Tampa, Florida, 33607

  • Javara Research - Thomasville- Site Number : 8401189

    Thomasville, Georgia, 31792

  • Revival Research Institute - Troy- Site Number : 8401012

    Troy, Michigan, 48084

  • Oakland Medical Center- Site Number : 8401116

    Troy, Michigan, 48085

  • Eclipse Clinical Research- Site Number : 8401158

    Tucson, Arizona, 85745

  • Rophe Adult & Pediatric Medicine- Site Number : 8401289

    Union City, Georgia, 30291

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

    Ypsilanti, Michigan, 48197

Other trials in United States

China29 sites

  • Investigational Site Number : 1560042

    Beijing, 100034

  • Investigational Site Number : 1560004

    Beijing, 100191

  • Investigational Site Number : 1560030

    Beijing, 100730

  • Investigational Site Number : 1560050

    Changsha, 410011

  • Investigational Site Number : 1560022

    Chengdu, 610041

  • Investigational Site Number : 1560060

    Chengdu, 610072

  • Investigational Site Number : 1560068

    Chengdu, 610091

  • Investigational Site Number : 1560057

    Chongqing, 400016

  • Investigational Site Number : 1560065

    Chongqing, 400065

  • Investigational Site Number : 1560043

    Fuzhou, 350005

  • Investigational Site Number : 1560021

    Guangzhou, 510018

  • Investigational Site Number : 1560025

    Guangzhou, 510080

  • Investigational Site Number : 1560058

    Guangzhou, 510630

  • Investigational Site Number : 1560044

    Hangzhou, 310003

  • Investigational Site Number : 1560002

    Hangzhou, 310006

  • Investigational Site Number : 1560006

    Hangzhou, 310009

  • Investigational Site Number : 1560029

    Hangzhou, 310014

  • Investigational Site Number : 1560007

    Jinan, 250013

  • Investigational Site Number : 1560051

    Nanchang, 330001

  • Investigational Site Number : 1560024

    Ningbo, 315010

  • Investigational Site Number : 1560001

    Shanghai, 200040

  • Investigational Site Number : 1560005

    Shanghai, 200443

  • Investigational Site Number : 1560041

    Shenyang, 110001

  • Investigational Site Number : 1560026

    Shenyang, 110179

  • Investigational Site Number : 1560064

    Shenzhen, 518026

  • Investigational Site Number : 1560023

    Wenzhou, 325035

  • Investigational Site Number : 1560049

    Wuhan, 430022

  • Investigational Site Number : 1560003

    Wuxi, 214000

  • Investigational Site Number : 1560028

    Zhenjiang, 212000

Other trials in China

Argentina22 sites

  • Investigational Site Number : 0320021

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320022

    Buenos Aires, 1012

  • Investigational Site Number : 0320023

    Buenos Aires, 1028

  • Investigational Site Number : 0320011

    Buenos Aires, 1035

  • Investigational Site Number : 0320016

    Buenos Aires, 1055

  • Investigational Site Number : 0320008

    Buenos Aires, 1061

  • Investigational Site Number : 0320001

    Buenos Aires, 1121

  • Investigational Site Number : 0320018

    Buenos Aires, 1178

  • Investigational Site Number : 0320010

    Buenos Aires, 1414

  • Investigational Site Number : 0320002

    Buenos Aires, 1425

  • Investigational Site Number : 0320004

    Buenos Aires, 1425

  • Investigational Site Number : 0320009

    Buenos Aires, 1425

  • Investigational Site Number : 0320019

    Buenos Aires, 1426

  • Investigational Site Number : 0320005

    Buenos Aires, 1427

  • Investigational Site Number : 0320012

    Corrientes, 3400

  • Investigational Site Number : 0320013

    Mendoza, 5500

  • Investigational Site Number : 0320017

    Pilar, Buenos Aires, 1629

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320015

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320024

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigational Site Number : 0320020

    San Miguel de Tucumán, Tucumán Province, T4000AXL

Other trials in Argentina

Canada20 sites

  • Investigational Site Number : 1240033

    Ajax, Ontario, L1S 7K8

  • Investigational Site Number : 1240039

    Calgary, Alberta, T2J 7E1

  • Investigational Site Number : 1240031

    Edmonton, Alberta, T5K 2V4

  • Investigational Site Number : 1240046

    Kelowna, British Columbia, V1Y 4N7

  • Investigational Site Number : 1240029

    London, Ontario, L6A 2C2

  • Investigational Site Number : 1241106

    Markham, Ontario, L3P 1X3

  • Investigational Site Number : 1240008

    Mississauga, Ontario, L5H 1G9

  • Investigational Site Number : 1241108

    Niagara Falls, Ontario, L2H 1H5

  • Investigational Site Number : 1240034

    Ottawa, Ontario, K1K 4L2

  • Investigational Site Number : 1240006

    Québec, Quebec, G1W 4R4

  • Investigational Site Number : 1240045

    Red Deer, Alberta, T4P 1K4

  • Investigational Site Number : 1240028

    Regina, Saskatchewan, S4V 1R9

  • Investigational Site Number : 1240038

    Richmond Hill, Ontario, L4E 4L6

  • Investigational Site Number : 1240036

    Saskatoon, Saskatchewan, S7K 0H6

  • Investigational Site Number : 1240040

    Surrey, British Columbia, V3R 6A7

  • Investigational Site Number : 1240030

    Surrey, British Columbia, V3V 0C6

  • Investigational Site Number : 1240012

    Toronto, Ontario, M3H 5Y8

  • Investigational Site Number : 1240035

    Toronto, Ontario, M5A 3R6

  • Investigational Site Number : 1241107

    Waterloo, Ontario, N2J 1C4

  • Investigational Site Number : 1240041

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Japan18 sites

  • Investigational Site Number : 3920009

    Chitose, Hokkaido, 066-0021

  • Investigational Site Number : 3920004

    Chūō, Tokyo, 104-0031

  • Investigational Site Number : 3923109

    Habikino, Osaka, 583-8588

  • Investigational Site Number : 3920002

    Iruma, Saitama, 350-0495

  • Investigational Site Number : 3923108

    Kagoshima, 890-0063

  • Investigational Site Number : 3920006

    Kobe, Hyōgo, 653-0836

  • Investigational Site Number : 3923102

    Kyoto, 602-8566

  • Investigational Site Number : 3920003

    Kyoto, 606-8507

  • Investigational Site Number : 3923106

    Mibu, Tochigi, 321-0293

  • Investigational Site Number : 3923107

    Minato, Tokyo, 108-0014

  • Investigational Site Number : 3920010

    Miyagi-gun, Miyagi, 981-0112

  • Investigational Site Number : 3923114

    Obihiro, Hokkaido, 080-0013

  • Investigational Site Number : 3920005

    Sagamihara, Kanagawa, 252-0315

  • Investigational Site Number : 3923110

    Sakai, Osaka, 593-8324

  • Investigational Site Number : 3920008

    Sapporo, Hokkaido, 064-0921

  • Investigational Site Number : 3920011

    Sendai, Miyagi, 981-3133

  • Investigational Site Number : 3920001

    Tachikawa, Tokyo, 190-0023

  • Investigational Site Number : 3923113

    Yokohama, Kanagawa, 221-0825

Other trials in Japan

Brazil14 sites

  • Hospital São Domingos- Site Number : 0760028

    Bequimão, Maranhão, 65060-645

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

    Curitiba, Paraná, 80060-900

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

    Curitiba, Paraná, 80230-130

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

    Porto Alegre, Rio Grande do Sul, 90020-090

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

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Ribeirão Preto, São Paulo, 14049-900

  • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018

    Rio de Janeiro, 22241-180

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

    Salvador, Estado de Bahia, 41820-020

  • Faculdade de Medicina do ABC- Site Number : 0760001

    Santo André, São Paulo, 09060-650

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

    São Paulo, 01323-020

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

    São Paulo, 04020-060

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

    São Paulo, 05403-000

  • Clinica de Alergia Martti Antila- Site Number : 0760006

    Sorocaba, São Paulo, 18040-425

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

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Chile14 sites

  • Investigational Site Number : 1520009

    Osorno, Reg Metropolitana de Santiago, 5311523

  • Investigational Site Number : 1520015

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520013

    Santiago, Reg Metropolitana de Santiago, 7500505

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 7500587

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7580206

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520014

    Santiago, Reg Metropolitana de Santiago, 7750000

  • Investigational Site Number : 1520010

    Santiago, Reg Metropolitana de Santiago, 8330034

  • Investigational Site Number : 1520011

    Santiago, Reg Metropolitana de Santiago, 8380456

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 8380465

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383

  • Investigational Site Number : 1520012

    Talcahuano, Biobio, 2687000

  • Investigational Site Number : 1520004

    Valdivia, Los Ríos Region, 5110683

  • Investigational Site Number : 1520006

    Viña del Mar, Valparaiso, 2530900

Other trials in Chile

South Korea13 sites

  • Investigational Site Number : 4100002

    Ansan-si, Gyeonggi-do, 15355

  • Investigational Site Number : 4100015

    Bupyeong-gu, Incheon-gwangyeoksi, 21431

  • Investigational Site Number : 4100008

    Daegu, Daegu, 41944

  • Investigational Site Number : 4100012

    Gwangju, Gwangju, 61453

  • Investigational Site Number : 4100014

    Seongnam-si, Gyeonggi-do, 13620

  • Investigational Site Number : 4100010

    Seoul, Seoul-teukbyeolsi, 01812

  • Investigational Site Number : 4100013

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100007

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100011

    Seoul, Seoul-teukbyeolsi, 06591

  • Investigational Site Number : 4100017

    Seoul, Seoul-teukbyeolsi, 07804

  • Investigational Site Number : 4100009

    Suwon, Gyeonggi-do, 16499

  • Investigational Site Number : 4100003

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Spain12 sites

  • Investigational Site Number : 7242505

    Alicante, 03010

  • Investigational Site Number : 7240008

    Bilbao, Basque Country, 48013

  • Investigational Site Number : 7240023

    Burjassot - Valencia, Valenciana, Comunidad, 46100

  • Investigational Site Number : 7240010

    Esplugues de Llobregat, Barcelona [Barcelona], 08950

  • Investigational Site Number : 7240018

    Granada, 18014

  • Investigational Site Number : 7240019

    Granada, 18016

  • Investigational Site Number : 7240012

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Investigational Site Number : 7240029

    Madrid, 28007

  • Investigational Site Number : 7242503

    Madrid, 28046

  • Investigational Site Number : 7240015

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240020

    Seville, Sevilla, 41013

  • Investigational Site Number : 7240014

    Vigo, Pontevedra [Pontevedra], 36206

Other trials in Spain

Czechia8 sites

  • Investigational Site Number : 2032106

    Kutná Hora, 284 01

  • Investigational Site Number : 2032105

    Nový Jičín, 741 00

  • Investigational Site Number : 2030010

    Olomouc, 779 00

  • Investigational Site Number : 2032104

    Ostrava, 702 00

  • Investigational Site Number : 2030009

    Pilsen, 323 00

  • Investigational Site Number : 2030008

    Prague, 110 01

  • Investigational Site Number : 2030011

    Prague, 150 00

  • Investigational Site Number : 2030006

    Prague, 160 00

Other trials in Czechia

France8 sites

  • Investigational Site Number : 2500008

    Antony, 92160

  • Investigational Site Number : 2500013

    Nice, 06202

  • Investigational Site Number : 2500003

    Paris, 75010

  • Investigational Site Number : 2500006

    Pierre-Bénite, 69495

  • Investigational Site Number : 2500007

    Reims, 51100

  • Investigational Site Number : 2500010

    Romans-sur-Isère, 26102

  • Investigational Site Number : 2500012

    Rouen, 76031

  • Investigational Site Number : 2500002

    Toulouse, 31059

Other trials in France

Germany8 sites

  • Investigational Site Number : 2760020

    Augsburg, 86150

  • Investigational Site Number : 2760009

    Bad Bentheim, 48455

  • Investigational Site Number : 2760017

    Hamburg, 20095

  • Investigational Site Number : 2760021

    Hamburg, 20354

  • Investigational Site Number : 2762208

    Kiel, 24105

  • Investigational Site Number : 2760016

    Mainz, 55128

  • Investigational Site Number : 2762201

    Münster, 48149

  • Investigational Site Number : 2760019

    Witten, 58453

Other trials in Germany

Italy8 sites

  • Investigational Site Number : 3800012

    Bologna, 40138

  • Investigational Site Number : 3800009

    Catania, 95123

  • Investigational Site Number : 3800011

    L’Aquila, 67100

  • Investigational Site Number : 3800003

    Milan, Milano, 20122

  • Investigational Site Number : 3800008

    Pisa, 56126

  • Investigational Site Number : 3800013

    Rome, Roma, 00133

  • Investigational Site Number : 3800018

    Rozzano, Milano, 20089

  • Investigational Site Number : 3800022

    Vicenza, 36100

Other trials in Italy

Poland8 sites

  • Investigational Site Number : 6160006

    Gdansk, Pomeranian Voivodeship, 80-546

  • Investigational Site Number : 6160003

    Katowice, Silesian Voivodeship, 40-611

  • Investigational Site Number : 6162406

    Krakow, Lesser Poland Voivodeship, 31-209

  • Investigational Site Number : 6160002

    Lodz, Lódzkie, 90-265

  • Investigational Site Number : 6160004

    Lublin, Lublin Voivodeship, 20-607

  • Investigational Site Number : 6160010

    Tarnów, Lesser Poland Voivodeship, 33-100

  • Investigational Site Number : 6160009

    Warsaw, Masovian Voivodeship, 02-625

  • Investigational Site Number : 6160007

    Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

Turkey (Türkiye)8 sites

  • Investigational Site Number : 7920001

    Antalya, 07070

  • Investigational Site Number : 7920005

    Istanbul, 34093

  • Investigational Site Number : 7920006

    Istanbul, 34093

  • Investigational Site Number : 7920002

    Istanbul, 34098

  • Investigational Site Number : 7920009

    Istanbul, 34662

  • Investigational Site Number : 7920004

    Kayseri, 38039

  • Investigational Site Number : 7920011

    Mersin, 34343

  • Investigational Site Number : 7920007

    Samsun, 55139

Other trials in Turkey (Türkiye)

India7 sites

  • Investigational Site Number : 3560001

    Ahmedabad, 380016

  • Investigational Site Number : 3560005

    Belagavi, 590002

  • Investigational Site Number : 3560004

    Chandigarh, 160012

  • Investigational Site Number : 3560006

    Faridabad, 121002

  • Investigational Site Number : 3560007

    Kolkata, 700073

  • Investigational Site Number : 3560002

    Nagpur, 441203

  • Investigational Site Number : 3560003

    Pune, 411057

Other trials in India

South Africa7 sites

  • Investigational Site Number : 7100015

    Benoni, 1500

  • Investigational Site Number : 7100010

    Cape Town, 7533

  • Investigational Site Number : 7100009

    Cape Town, 7708

  • Investigational Site Number : 7100012

    Durban, 3630

  • Investigational Site Number : 7100001

    Durban, 4058

  • Investigational Site Number : 7100007

    Johannesburg, 2196

  • Investigational Site Number : 7100003

    Pretoria, 0009

Other trials in South Africa

Israel6 sites

  • Investigational Site Number : 3760004

    Afula, 1834111

  • Investigational Site Number : 3760005

    Beersheba, 8457108

  • Investigational Site Number : 3760001

    Haifa, 3109601

  • Investigational Site Number : 3760003

    Jerusalem, 9112001

  • Investigational Site Number : 3760006

    Petah Tikva, 4920235

  • Investigational Site Number : 3760002

    Petah Tikva, 4941492

Other trials in Israel

Australia5 sites

  • Investigational Site Number : 0360008

    Melbourne, Victoria, 3002

  • Investigational Site Number : 0360006

    Melbourne, Victoria, 3004

  • Investigational Site Number : 0361006

    Traralgon, Victoria, 3844

  • Investigational Site Number : 0360010

    Westmead, New South Wales, 2145

  • Investigational Site Number : 0360007

    Woolloongabba, Queensland, 4102

Other trials in Australia

Mexico5 sites

  • Investigational Site Number : 4840012

    Aguascalientes, 20127

  • Investigational Site Number : 4840009

    Durango, 34000

  • Investigational Site Number : 4840011

    Monterrey, Nuevo León, 64460

  • Investigational Site Number : 4840005

    Monterrey, Nuevo León, 64718

  • Investigational Site Number : 4840003

    Veracruz, 91900

Other trials in Mexico

United Kingdom5 sites

  • Investigational Site Number : 8260006

    Glasgow, G3 8SJ

  • Investigational Site Number : 8260004

    Leicester, Leicestershire, LE2 0TA

  • Investigational Site Number : 8262601

    London, London, City of, SE1 9RT

  • Investigational Site Number : 8262602

    London, London, City of, SE1 9RT

  • Investigational Site Number : 8260003

    Portsmouth, Hampshire, PO3 6DW

Other trials in United Kingdom

Portugal4 sites

  • Investigational Site Number : 6200005

    Lisbon, 1169-050

  • Investigational Site Number : 6200004

    Lisbon, 1649-035

  • Investigational Site Number : 6200001

    Lisbon, 1998-018

  • Investigational Site Number : 6200003

    Porto, 4099-001

Other trials in Portugal

Taiwan4 sites

  • Investigational Site Number : 1583201

    Kaohsiung City, 833

  • Investigational Site Number : 1583202

    Taichung, 402

  • Investigational Site Number : 1580001

    Taipei, 100

  • Investigational Site Number : 1580003

    Taipei, 112

Other trials in Taiwan

Bulgaria3 sites

  • Investigational Site Number : 1002007

    Dupnitsa, 2600

  • Investigational Site Number : 1002004

    Pleven, 5800

  • Investigational Site Number : 1002005

    Sofia, 1431

Other trials in Bulgaria

Denmark3 sites

  • Investigational Site Number : 2080002

    Aalborg, 9000

  • Investigational Site Number : 2080001

    Aarhus, 8200

  • Investigational Site Number : 2080003

    Herlev, 2730

Other trials in Denmark

Greece2 sites

  • Investigational Site Number : 3000001

    Athens, 161 21

  • Investigational Site Number : 3000002

    Thessaloniki, 54643

Other trials in Greece

Sweden1 site

  • Investigational Site Number : 7520006

    Älvsjö, 125 44

Other trials in Sweden

About this study

Official title: A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD).

The primary objective of ESTUARY is to assess the maintenance of treatment response on continued Q12W dosing compared to treatment withdrawal.

Read more

Study details include:

The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD).

The study duration will be up to 52 weeks for participants entering the LTS17367 [RIVER-AD] study at the Week 52 visit of EFC17600 (ESTUARY).

Being tested
Amlitelimab, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmlitelimabDrug

    Also called SAR445229

    Pharmaceutical form: Injection solution

    Route of administration: Subcutaneous (SC) injection

  • PlaceboDrug

    Pharmaceutical form: Injection solution

    Route of administration: SC injection

Study groups in NCT06407934
Study groupRoleWhat they receive
Amlitelimab dose 1ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab
Amlitelimab dose 2ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab
PlaceboPlacebo comparatorSubcutaneous injection as per protocol
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. US and US reference countries: Proportion of participants who are responders AND maintained vIGA-AD ≤2 without experiencing relapse among participants who were responders at baseline of ESTUARY

    Clinical response is defined as having vIGA-AD 0 or 1. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^. The validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The Eczema Area and Severity Index (EASI) is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Week 24

  2. EU, EU Reference Countries, and Japan: Proportion of participants who maintain treatment response in ESTUARY without experiencing relapse

    Maintenance of clinical response is defined as having vIGA-AD 0 or 1 OR EASI-75^ OR vIGA-AD 0 or 1 and EASI-75^.

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Week 48

Secondary outcomes (48)

  1. Proportion of participants who continue to be EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  2. Proportion of participants who continue to be vIGA-AD 0 or 1 among participants who met vIGA-AD 0 or 1 at baseline of ESTUARY

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Measured: Up to Week 48

  3. Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among the participants who were vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting.

    Measured: Up to Week 48

  4. Proportion of participants who maintained weekly average of daily PP-NRS reduction of ≥4^ among the participants with weekly average of daily PP-NRS reduction of ≥ 4^ at baseline of ESTUARY

    The Peak Pruritus-Numerical Rating Scale (PP-NRS) is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  5. Proportion of participants who maintain treatment response without experiencing relapse

    Maintenance of treatment response is defined as having vIGA-AD 0 or 1 OR EASI-75^ OR vIGA-AD 0 or 1 and EASI-75^.

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Measured: Up to Week 48

  6. Percent change in EASI from parent study baseline

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Measured: Parent study baseline to Week 48

  7. Proportion of participants who maintained EASI-75^ without experiencing relapse among the participants who met EASI-75^ at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  8. Proportion of participants with EASI-75^

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  9. Proportion of participants who continue to be EASI-90^ among the participants who met EASI-90^ at baseline of ESTUARY

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  10. Proportion of participants with EASI-90^

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  11. Time to the first event of vIGA-AD ≥3 or loss of EASI-75^ among the participants who were vIGA-AD 0 or EASI-75^ at baseline of ESTUARY

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  12. Proportion of participants with vIGA-AD 0 or 1

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Measured: Up to Week 48

  13. Proportion of participants who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Measured: Up to Week 48

  14. EU, EU Reference Countries, and Japan: Time to first event of vIGA-AD ≥3 or loss of EASI^75 among those participants who were vIGA-AD 0 or 1 at baseline of ESTUARY

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  15. EU, EU Reference Countries, and Japan: Time to first event of vIGA-AD ≥3 or loss of EASI^75 among those participants who were vIGA-AD 0 at baseline of ESTUARY

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  16. Proportion of participants with weekly average of daily PP-NRS reduction of ≥4^

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. The symbol ^ represents "based on parent study baseline".

    Measured: Parent study baseline to Week 48

  17. Proportion of participants who maintain PP-NRS ≤4 among participants who were PP-NRS ≤4 at baseline of ESTUARY

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.

    Measured: Up to Week 48

  18. EU, EU Reference Countries, and Japan: Proportion of participants who maintain reduction in POEM ≥4^ among the participants with reduction in POEM ≥4^ at baseline of ESTUARY

    The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  19. EU, EU Reference Countries, and Japan: Proportion of participants with a reduction in CDLQI ≥6^ among participants aged ≥12 to <16 years old and with reduction in CDLQI ≥6^ at baseline of ESTUARY

    The Children's Dermatology Quality of Life Index (CDLQI) is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  20. EU, EU Reference Countries, and Japan: Proportion of participants with ≥ 4 reduction in DLQI ≥4^ among the participants aged ≥16 years old and with reduction in DLQI ≥4^ at baseline of ESTUARY

    The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Measured: Up to Week 48

  21. Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)

    Measured: Up to week 68

  22. Pharmacokinetic: Serum amlitelimab concentrations

    Measured: Up to Week 68

  23. Incidence of antidrug antibodies (ADAs) of amlitelimab

    Measured: Up to Week 68

  24. Pharmacokinetic: maximum plasma concentration (Cmax)

    Measured: Up to Week 68

  25. Pharmacokinetic: AUC4W and AUC12W

    Cumulative area under the serum concentration curve over 4 weeks (AUC4W). Cumulative area under the serum concentration curve over 12 weeks (AUC12W).

    Measured: Up to Week 4 and 12

  26. Proportion of participants who are EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and did not relapse by Week 12

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  27. Time to first recapture of EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  28. Proportion of participants who recapture EASI-75^ by visit among the participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  29. Proportion of participants who are EASI 90^ AND who maintain EASI-75^ without experiencing relapse among participants who had EASI-90^ at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  30. Proportion of participants who are EASI 90^ without experiencing relapse among participants who had EASI-90^ at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  31. Proportion of participants who are EASI-90^ among participants who had EASI-90^ at baseline of ESTUARY and did not relapse by Week 12.

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  32. Proportion of participants who are vIGA-AD 0 or 1 AND who maintain vIGA-AD ≤2 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  33. Proportion of participants who maintain vIGA-AD response within 1 point of baseline without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  34. Proportion of participants who maintain vIGA-AD 0 or 1 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  35. Proportion of participants who are vIGA-AD 0 or 1 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  36. Time to first recapture of vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and subsequently relapsed

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Measured: Up to Week 48

  37. Proportion of participants who recapture vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and subsequently relapsed

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Measured: Up to Week 48

  38. Proportion of participants who are vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and did not relapse by Week 12

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  39. Proportion of participants who are vIGA-AD 0 or 1 with only barely perceptible erythema AND who maintain vIGA-AD ≤2 without experiencing relapse among participants who had vIGA-AD 0 or 1 with only barely perceptible erythema at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting.

    Measured: Up to Week 48

  40. Proportion of participants who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema among participants who had vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY and did not relapse by Week 12

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting.

    Measured: Up to Week 48

  41. Proportion of participants who maintain weekly average of daily PP-NRS reduction of ≥4^ without experiencing relapse among participants with weekly average of daily PP NRS reduction of ≥4^ at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  42. Proportion of participants who maintain PP NRS ≤4 without experiencing relapse among participants who had PP-NRS ≤4 at baseline of ESTUARY

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  43. Proportion of participants who achieve PP-NRS reduction of ≥4

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.

    Measured: Up to Week 48

  44. Proportion of participants who achieve PP-NRS ≤4

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.

    Measured: Up to Week 48

  45. Duration of maintained response without relapse

    Maintenance of clinical response is defined as having vIGA-AD 0 or 1 OR EASI-75^ OR vIGA-AD 0 or 1 and EASI-75^.

    Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Measured: Up to Week 48

  46. Percent change in Head & Neck EASI sub-score from the parent study baseline among participants with Head & Neck EASI sub-score >0 at baseline of the parent study

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head \& Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head \& Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Measured: From parent study baseline to Week 48

  47. Proportion of participants Head & Neck EASI sub-score EASI-75^ among participants with Head & Neck EASI sub-score >0 at baseline of the parent study

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head \& Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head \& Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Head \& Neck EASI sub-score EASI-75 is 75% reduction from baseline in Head \& Neck EASI sub-score. The symbol ^ represents "based on parent study baseline"

    Measured: From parent study baseline to Week 48

  48. Proportion of participants with Head & Neck EASI sub-score EASI-90^ among participants with Head & Neck EASI sub-score >0 at baseline of parent study

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head \& Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head \& Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Head \& Neck EASI sub-score EASI-90 is 90% reduction from baseline in Head \& Neck EASI sub-score. The symbol ^ represents "based on parent study baseline"

    Measured: From parent study baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2024
  2. Study start8 May 2024
  3. Primary completion10 Jun 2026
  4. Study completion17 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,541 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06407934
Sponsor's protocol ID
EFC17600
Other IDs
U1111-1290-9215, 2023-508096-36, 2023
Acronym
ESTUARY
Status last verified
Jul 2026
First submitted
6 May 2024
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amlitelimab in people with Dermatitis Atopic, run by Sanofi at 324 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 324 sites in United States, China, Argentina, Canada, Japan and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

US and US reference countries: Proportion of participants who are responders AND maintained vIGA-AD ≤2 without experiencing relapse among participants who were responders at baseline of ESTUARY (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06407934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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