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 (ESTUARY)

April 15, 2026 updated by: Sanofi

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.

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).

Study Overview

Status

Active, not recruiting

Conditions

Dermatitis Atopic

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1541

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1035
    - Investigational Site Number : 0320011
  - Buenos Aires, Argentina, 1061
    - Investigational Site Number : 0320008
  - Buenos Aires, Argentina, 1178
    - Investigational Site Number : 0320018
  - Buenos Aires, Argentina, 1414
    - Investigational Site Number : 0320010
  - Buenos Aires, Argentina, 1425
    - Investigational Site Number : 0320004
  - Buenos Aires, Argentina, 1012
    - Investigational Site Number : 0320022
  - Buenos Aires, Argentina, 1425
    - Investigational Site Number : 0320002
  - Buenos Aires, Argentina, 1055
    - Investigational Site Number : 0320016
  - Buenos Aires, Argentina, 1121
    - Investigational Site Number : 0320001
  - Buenos Aires, Argentina, 1425
    - Investigational Site Number : 0320009
  - Buenos Aires, Argentina, 1028
    - Investigational Site Number : 0320023
  - Buenos Aires, Argentina, 1426
    - Investigational Site Number : 0320019
  - Buenos Aires, Argentina, 1427
    - Investigational Site Number : 0320005
  - Corrientes, Argentina, 3400
    - Investigational Site Number : 0320012
  - Mendoza, Argentina, 5500
    - Investigational Site Number : 0320013
- Buenos Aires
  - Berazategui, Buenos Aires, Argentina, 1886
    - Investigational Site Number : 0320021
  - Pilar, Buenos Aires, Argentina, 1629
    - Investigational Site Number : 0320017
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
    - Investigational Site Number : 0320006
  - Rosario, Santa Fe Province, Argentina, 2000
    - Investigational Site Number : 0320007
  - Rosario, Santa Fe Province, Argentina, 2000
    - Investigational Site Number : 0320015
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Investigational Site Number : 0320024
  - San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
    - Investigational Site Number : 0320020
Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Investigational Site Number : 0360010
- Queensland
  - Woolloongabba, Queensland, Australia, 4102
    - Investigational Site Number : 0360007
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - Investigational Site Number : 0360006
  - Melbourne, Victoria, Australia, 3002
    - Investigational Site Number : 0360008
  - Traralgon, Victoria, Australia, 3844
    - Investigational Site Number : 0361006
Brazil
- - Rio de Janeiro, Brazil, 22241-180
    - CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018
  - São Paulo, Brazil, 01323-020
    - Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
  - São Paulo, Brazil, 04020-060
    - Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
  - São Paulo, Brazil, 05403-000
    - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012
- Espírito Santo
  - Vitória, Espírito Santo, Brazil, 29055-450
    - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 41820-020
    - Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
- Maranhão
  - Bequimão, Maranhão, Brazil, 65060-645
    - Hospital São Domingos- Site Number : 0760028
- Paraná
  - Curitiba, Paraná, Brazil, 80230-130
    - PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023
  - Curitiba, Paraná, Brazil, 80060-900
    - Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
    - Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
  - Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
    - Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024
- São Paulo
  - Ribeirão Preto, São Paulo, Brazil, 14049-900
    - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015
  - Santo André, São Paulo, Brazil, 09060-650
    - Faculdade de Medicina do ABC- Site Number : 0760001
  - Sorocaba, São Paulo, Brazil, 18040-425
    - Clinica de Alergia Martti Antila- Site Number : 0760006
Bulgaria
- - Dupnitsa, Bulgaria, 2600
    - Investigational Site Number : 1002007
  - Pleven, Bulgaria, 5800
    - Investigational Site Number : 1002004
  - Sofia, Bulgaria, 1431
    - Investigational Site Number : 1002005
Canada
- Alberta
  - Calgary, Alberta, Canada, T2J 7E1
    - Investigational Site Number : 1240039
  - Edmonton, Alberta, Canada, T5K 2V4
    - Investigational Site Number : 1240031
  - Red Deer, Alberta, Canada, T4P 1K4
    - Investigational Site Number : 1240045
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 4N7
    - Investigational Site Number : 1240046
  - Surrey, British Columbia, Canada, V3V 0C6
    - Investigational Site Number : 1240030
  - Surrey, British Columbia, Canada, V3R 6A7
    - Investigational Site Number : 1240040
- Manitoba
  - Winnipeg, Manitoba, Canada, R3M 3Z4
    - Investigational Site Number : 1240041
- Ontario
  - Ajax, Ontario, Canada, L1S 7K8
    - Investigational Site Number : 1240033
  - London, Ontario, Canada, L6A 2C2
    - Investigational Site Number : 1240029
  - Markham, Ontario, Canada, L3P 1X3
    - Investigational Site Number : 1241106
  - Mississauga, Ontario, Canada, L5H 1G9
    - Investigational Site Number : 1240008
  - Niagara Falls, Ontario, Canada, L2H 1H5
    - Investigational Site Number : 1241108
  - Ottawa, Ontario, Canada, K1K 4L2
    - Investigational Site Number : 1240034
  - Richmond Hill, Ontario, Canada, L4E 4L6
    - Investigational Site Number : 1240038
  - Toronto, Ontario, Canada, M3H 5Y8
    - Investigational Site Number : 1240012
  - Toronto, Ontario, Canada, M5A 3R6
    - Investigational Site Number : 1240035
  - Waterloo, Ontario, Canada, N2J 1C4
    - Investigational Site Number : 1241107
- Quebec
  - Québec, Quebec, Canada, G1W 4R4
    - Investigational Site Number : 1240006
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4V 1R9
    - Investigational Site Number : 1240028
  - Saskatoon, Saskatchewan, Canada, S7K 0H6
    - Investigational Site Number : 1240036
Chile
- Biobio
  - Talcahuano, Biobio, Chile, 2687000
    - Investigational Site Number : 1520012
- Los Ríos Region
  - Valdivia, Los Ríos Region, Chile, 5110683
    - Investigational Site Number : 1520004
- Reg Metropolitana de Santiago
  - Osorno, Reg Metropolitana de Santiago, Chile, 5311523
    - Investigational Site Number : 1520009
  - Santiago, Reg Metropolitana de Santiago, Chile, 7580206
    - Investigational Site Number : 1520002
  - Santiago, Reg Metropolitana de Santiago, Chile, 7640881
    - Investigational Site Number : 1520003
  - Santiago, Reg Metropolitana de Santiago, Chile, 8380456
    - Investigational Site Number : 1520011
  - Santiago, Reg Metropolitana de Santiago, Chile, 8380465
    - Investigational Site Number : 1520005
  - Santiago, Reg Metropolitana de Santiago, Chile, 8420383
    - Investigational Site Number : 1520001
  - Santiago, Reg Metropolitana de Santiago, Chile, 7500587
    - Investigational Site Number : 1520008
  - Santiago, Reg Metropolitana de Santiago, Chile, 8330034
    - Investigational Site Number : 1520010
  - Santiago, Reg Metropolitana de Santiago, Chile, 7500505
    - Investigational Site Number : 1520013
  - Santiago, Reg Metropolitana de Santiago, Chile, 7750000
    - Investigational Site Number : 1520014
- Valparaiso
  - Quillota, Valparaiso, Chile, 2260877
    - Investigational Site Number : 1520015
  - Viña del Mar, Valparaiso, Chile, 2530900
    - Investigational Site Number : 1520006
China
- - Beijing, China, 100034
    - Investigational Site Number : 1560042
  - Beijing, China, 100191
    - Investigational Site Number : 1560004
  - Beijing, China, 100730
    - Investigational Site Number : 1560030
  - Changsha, China, 410011
    - Investigational Site Number : 1560050
  - Chengdu, China, 610041
    - Investigational Site Number : 1560022
  - Chengdu, China, 610072
    - Investigational Site Number : 1560060
  - Chengdu, China, 610091
    - Investigational Site Number : 1560068
  - Chongqing, China, 400016
    - Investigational Site Number : 1560057
  - Chongqing, China, 400065
    - Investigational Site Number : 1560065
  - Fuzhou, China, 350005
    - Investigational Site Number : 1560043
  - Guangzhou, China, 510018
    - Investigational Site Number : 1560021
  - Guangzhou, China, 510630
    - Investigational Site Number : 1560058
  - Guangzhou, China, 510080
    - Investigational Site Number : 1560025
  - Hangzhou, China, 310006
    - Investigational Site Number : 1560002
  - Hangzhou, China, 310009
    - Investigational Site Number : 1560006
  - Hangzhou, China, 310003
    - Investigational Site Number : 1560044
  - Hangzhou, China, 310014
    - Investigational Site Number : 1560029
  - Jinan, China, 250013
    - Investigational Site Number : 1560007
  - Nanchang, China, 330001
    - Investigational Site Number : 1560051
  - Ningbo, China, 315010
    - Investigational Site Number : 1560024
  - Shanghai, China, 200040
    - Investigational Site Number : 1560001
  - Shanghai, China, 200443
    - Investigational Site Number : 1560005
  - Shenyang, China, 110001
    - Investigational Site Number : 1560041
  - Shenyang, China, 110179
    - Investigational Site Number : 1560026
  - Shenzhen, China, 518026
    - Investigational Site Number : 1560064
  - Wenzhou, China, 325035
    - Investigational Site Number : 1560023
  - Wuhan, China, 430022
    - Investigational Site Number : 1560049
  - Wuxi, China, 214000
    - Investigational Site Number : 1560003
  - Zhenjiang, China, 212000
    - Investigational Site Number : 1560028
Czechia
- - Kutná Hora, Czechia, 284 01
    - Investigational Site Number : 2032106
  - Nový Jičín, Czechia, 741 00
    - Investigational Site Number : 2032105
  - Olomouc, Czechia, 779 00
    - Investigational Site Number : 2030010
  - Ostrava, Czechia, 702 00
    - Investigational Site Number : 2032104
  - Pilsen, Czechia, 323 00
    - Investigational Site Number : 2030009
  - Prague, Czechia, 150 00
    - Investigational Site Number : 2030011
  - Prague, Czechia, 160 00
    - Investigational Site Number : 2030006
  - Prague, Czechia, 110 01
    - Investigational Site Number : 2030008
Denmark
- - Aalborg, Denmark, 9000
    - Investigational Site Number : 2080002
  - Aarhus, Denmark, 8200
    - Investigational Site Number : 2080001
  - Herlev, Denmark, 2730
    - Investigational Site Number : 2080003
France
- - Antony, France, 92160
    - Investigational Site Number : 2500008
  - Nice, France, 06202
    - Investigational Site Number : 2500013
  - Paris, France, 75010
    - Investigational Site Number : 2500003
  - Pierre-Bénite, France, 69495
    - Investigational Site Number : 2500006
  - Reims, France, 51100
    - Investigational Site Number : 2500007
  - Romans-sur-Isère, France, 26102
    - Investigational Site Number : 2500010
  - Rouen, France, 76031
    - Investigational Site Number : 2500012
  - Toulouse, France, 31059
    - Investigational Site Number : 2500002
Germany
- - Augsburg, Germany, 86150
    - Investigational Site Number : 2760020
  - Bad Bentheim, Germany, 48455
    - Investigational Site Number : 2760009
  - Hamburg, Germany, 20095
    - Investigational Site Number : 2760017
  - Hamburg, Germany, 20354
    - Investigational Site Number : 2760021
  - Kiel, Germany, 24105
    - Investigational Site Number : 2762208
  - Mainz, Germany, 55128
    - Investigational Site Number : 2760016
  - Münster, Germany, 48149
    - Investigational Site Number : 2762201
  - Witten, Germany, 58453
    - Investigational Site Number : 2760019
Greece
- - Athens, Greece, 161 21
    - Investigational Site Number : 3000001
  - Thessaloniki, Greece, 54643
    - Investigational Site Number : 3000002
India
- - Ahmedabad, India, 380016
    - Investigational Site Number : 3560001
  - Belagavi, India, 590002
    - Investigational Site Number : 3560005
  - Chandigarh, India, 160012
    - Investigational Site Number : 3560004
  - Faridabad, India, 121002
    - Investigational Site Number : 3560006
  - Kolkata, India, 700073
    - Investigational Site Number : 3560007
  - Nagpur, India, 441203
    - Investigational Site Number : 3560002
  - Pune, India, 411057
    - Investigational Site Number : 3560003
Israel
- - Afula, Israel, 1834111
    - Investigational Site Number : 3760004
  - Beersheba, Israel, 8457108
    - Investigational Site Number : 3760005
  - Haifa, Israel, 3109601
    - Investigational Site Number : 3760001
  - Jerusalem, Israel, 9112001
    - Investigational Site Number : 3760003
  - Petah Tikva, Israel, 4941492
    - Investigational Site Number : 3760002
  - Petah Tikva, Israel, 4920235
    - Investigational Site Number : 3760006
Italy
- - Bologna, Italy, 40138
    - Investigational Site Number : 3800012
  - Catania, Italy, 95123
    - Investigational Site Number : 3800009
  - L’Aquila, Italy, 67100
    - Investigational Site Number : 3800011
  - Pisa, Italy, 56126
    - Investigational Site Number : 3800008
  - Vicenza, Italy, 36100
    - Investigational Site Number : 3800022
- Milano
  - Milan, Milano, Italy, 20122
    - Investigational Site Number : 3800003
  - Rozzano, Milano, Italy, 20089
    - Investigational Site Number : 3800018
- Roma
  - Rome, Roma, Italy, 00133
    - Investigational Site Number : 3800013
Japan
- - Kagoshima, Japan, 890-0063
    - Investigational Site Number : 3923108
  - Kyoto, Japan, 606-8507
    - Investigational Site Number : 3920003
  - Kyoto, Japan, 602-8566
    - Investigational Site Number : 3923102
- Hokkaido
  - Chitose, Hokkaido, Japan, 066-0021
    - Investigational Site Number : 3920009
  - Obihiro, Hokkaido, Japan, 080-0013
    - Investigational Site Number : 3923114
  - Sapporo, Hokkaido, Japan, 064-0921
    - Investigational Site Number : 3920008
- Hyōgo
  - Kobe, Hyōgo, Japan, 653-0836
    - Investigational Site Number : 3920006
- Kanagawa
  - Sagamihara, Kanagawa, Japan, 252-0315
    - Investigational Site Number : 3920005
  - Yokohama, Kanagawa, Japan, 221-0825
    - Investigational Site Number : 3923113
- Miyagi
  - Miyagi-gun, Miyagi, Japan, 981-0112
    - Investigational Site Number : 3920010
  - Sendai, Miyagi, Japan, 981-3133
    - Investigational Site Number : 3920011
- Osaka
  - Habikino, Osaka, Japan, 583-8588
    - Investigational Site Number : 3923109
  - Sakai, Osaka, Japan, 593-8324
    - Investigational Site Number : 3923110
- Saitama
  - Iruma, Saitama, Japan, 350-0495
    - Investigational Site Number : 3920002
- Tochigi
  - Mibu, Tochigi, Japan, 321-0293
    - Investigational Site Number : 3923106
- Tokyo
  - Chūō, Tokyo, Japan, 104-0031
    - Investigational Site Number : 3920004
  - Minato, Tokyo, Japan, 108-0014
    - Investigational Site Number : 3923107
  - Tachikawa, Tokyo, Japan, 190-0023
    - Investigational Site Number : 3920001
Mexico
- - Aguascalientes, Mexico, 20127
    - Investigational Site Number : 4840012
  - Durango, Mexico, 34000
    - Investigational Site Number : 4840009
  - Veracruz, Mexico, 91900
    - Investigational Site Number : 4840003
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Investigational Site Number : 4840011
  - Monterrey, Nuevo León, Mexico, 64718
    - Investigational Site Number : 4840005
Poland
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 31-209
    - Investigational Site Number : 6162406
  - Tarnów, Lesser Poland Voivodeship, Poland, 33-100
    - Investigational Site Number : 6160010
- Lublin Voivodeship
  - Lublin, Lublin Voivodeship, Poland, 20-607
    - Investigational Site Number : 6160004
- Lódzkie
  - Lodz, Lódzkie, Poland, 90-265
    - Investigational Site Number : 6160002
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-625
    - Investigational Site Number : 6160009
  - Warsaw, Masovian Voivodeship, Poland, 02-962
    - Investigational Site Number : 6160007
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Poland, 80-546
    - Investigational Site Number : 6160006
- Silesian Voivodeship
  - Katowice, Silesian Voivodeship, Poland, 40-611
    - Investigational Site Number : 6160003
Portugal
- - Lisbon, Portugal, 1169-050
    - Investigational Site Number : 6200005
  - Lisbon, Portugal, 1649-035
    - Investigational Site Number : 6200004
  - Lisbon, Portugal, 1998-018
    - Investigational Site Number : 6200001
  - Porto, Portugal, 4099-001
    - Investigational Site Number : 6200003
South Africa
- - Benoni, South Africa, 1500
    - Investigational Site Number : 7100015
  - Cape Town, South Africa, 7533
    - Investigational Site Number : 7100010
  - Cape Town, South Africa, 7708
    - Investigational Site Number : 7100009
  - Durban, South Africa, 3630
    - Investigational Site Number : 7100012
  - Durban, South Africa, 4058
    - Investigational Site Number : 7100001
  - Johannesburg, South Africa, 2196
    - Investigational Site Number : 7100007
  - Pretoria, South Africa, 0009
    - Investigational Site Number : 7100003
South Korea
- Daegu
  - Daegu, Daegu, South Korea, 41944
    - Investigational Site Number : 4100008
- Gwangju
  - Gwangju, Gwangju, South Korea, 61453
    - Investigational Site Number : 4100012
- Gyeonggi-do
  - Ansan-si, Gyeonggi-do, South Korea, 15355
    - Investigational Site Number : 4100002
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Investigational Site Number : 4100014
  - Suwon, Gyeonggi-do, South Korea, 16499
    - Investigational Site Number : 4100009
- Gyeongsangnam-do
  - Yangsan, Gyeongsangnam-do, South Korea, 50612
    - Investigational Site Number : 4100003
- Incheon-gwangyeoksi
  - Bupyeong-gu, Incheon-gwangyeoksi, South Korea, 21431
    - Investigational Site Number : 4100015
- Seoul-teukbyeolsi
  - Seoul, Seoul-teukbyeolsi, South Korea, 01812
    - Investigational Site Number : 4100010
  - Seoul, Seoul-teukbyeolsi, South Korea, 03080
    - Investigational Site Number : 4100013
  - Seoul, Seoul-teukbyeolsi, South Korea, 03722
    - Investigational Site Number : 4100007
  - Seoul, Seoul-teukbyeolsi, South Korea, 05030
    - Investigational Site Number : 4100006
  - Seoul, Seoul-teukbyeolsi, South Korea, 06591
    - Investigational Site Number : 4100011
  - Seoul, Seoul-teukbyeolsi, South Korea, 07804
    - Investigational Site Number : 4100017
Spain
- - Alicante, Spain, 03010
    - Investigational Site Number : 7242505
  - Granada, Spain, 18014
    - Investigational Site Number : 7240018
  - Granada, Spain, 18016
    - Investigational Site Number : 7240019
  - Madrid, Spain, 28007
    - Investigational Site Number : 7240029
  - Madrid, Spain, 28046
    - Investigational Site Number : 7242503
- Barcelona [Barcelona]
  - Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
    - Investigational Site Number : 7240010
- Basque Country
  - Bilbao, Basque Country, Spain, 48013
    - Investigational Site Number : 7240008
- Las Palmas
  - Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
    - Investigational Site Number : 7240012
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Investigational Site Number : 7240015
- Pontevedra [Pontevedra]
  - Vigo, Pontevedra [Pontevedra], Spain, 36206
    - Investigational Site Number : 7240014
- Sevilla
  - Seville, Sevilla, Spain, 41013
    - Investigational Site Number : 7240020
- Valenciana, Comunidad
  - Burjassot - Valencia, Valenciana, Comunidad, Spain, 46100
    - Investigational Site Number : 7240023
Sweden
- - Älvsjö, Sweden, 125 44
    - Investigational Site Number : 7520006
  - Örebro, Sweden, 701 85
    - Investigational Site Number : 7520001
Taiwan
- - Kaohsiung City, Taiwan, 833
    - Investigational Site Number : 1583201
  - Taichung, Taiwan, 402
    - Investigational Site Number : 1583202
  - Taipei, Taiwan, 100
    - Investigational Site Number : 1580001
  - Taipei, Taiwan, 112
    - Investigational Site Number : 1580003
Turkey (Türkiye)
- - Antalya, Turkey (Türkiye), 07070
    - Investigational Site Number : 7920001
  - Gaziantep, Turkey (Türkiye), 27310
    - Investigational Site Number : 7920008
  - Istanbul, Turkey (Türkiye), 34093
    - Investigational Site Number : 7920005
  - Istanbul, Turkey (Türkiye), 34093
    - Investigational Site Number : 7920006
  - Istanbul, Turkey (Türkiye), 34098
    - Investigational Site Number : 7920002
  - Istanbul, Turkey (Türkiye), 34662
    - Investigational Site Number : 7920009
  - Kayseri, Turkey (Türkiye), 38039
    - Investigational Site Number : 7920004
  - Mersin, Turkey (Türkiye), 34343
    - Investigational Site Number : 7920011
  - Samsun, Turkey (Türkiye), 55139
    - Investigational Site Number : 7920007
United Kingdom
- - Glasgow, United Kingdom, G3 8SJ
    - Investigational Site Number : 8260006
- Hampshire
  - Portsmouth, Hampshire, United Kingdom, PO3 6DW
    - Investigational Site Number : 8260003
- Leicestershire
  - Leicester, Leicestershire, United Kingdom, LE2 0TA
    - Investigational Site Number : 8260004
- London, City of
  - London, London, City of, United Kingdom, SE1 9RT
    - Investigational Site Number : 8262601
  - London, London, City of, United Kingdom, SE1 9RT
    - Investigational Site Number : 8262602
United States
- Alabama
  - Birmingham, Alabama, United States, 35244
    - Cahaba Dermatology & Skin Health Center- Site Number : 8401066
- Arizona
  - Scottsdale, Arizona, United States, 85260
    - Scottsdale Clinical Trials- Site Number : 8401149
  - Scottsdale, Arizona, United States, 85260
    - Center for Dermatology and Plastic Surgery- Site Number : 8401119
  - Tucson, Arizona, United States, 85745
    - Eclipse Clinical Research- Site Number : 8401158
- Arkansas
  - Fort Smith, Arkansas, United States, 72916
    - Johnson Dermatology- Site Number : 8401076
- California
  - Encino, California, United States, 91436
    - Encino Research Center- Site Number : 8401042
  - Fountain Valley, California, United States, 92708
    - First OC Dermatology- Site Number : 8401025
  - Fremont, California, United States, 94538
    - Center for Dermatology Clinical Research- Site Number : 8401018
  - Huntington Beach, California, United States, 92647
    - Marvel Clinical Research- Site Number : 8401102
  - Lafayette, California, United States, 94549
    - Sunwise Clinical Research- Site Number : 8401022
  - Lomita, California, United States, 90717
    - Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027
  - Los Angeles, California, United States, 90057
    - LA Universal Research Center- Site Number : 8401064
  - Los Angeles, California, United States, 90045
    - Dermatology Research Associates - Los Angeles- Site Number : 8401092
  - Northridge, California, United States, 91325
    - Northridge Clinical Trials - Northridge- Site Number : 8401080
  - Oxnard, California, United States, 93030
    - Cura Clinical Research - Oxnard- Site Number : 8401142
  - Santa Ana, California, United States, 92701
    - Southern California Dermatology- Site Number : 8401043
  - Santa Monica, California, United States, 90404
    - Clinical Science Institute- Site Number : 8401028
- Connecticut
  - Farmington, Connecticut, United States, 06030
    - UConn Health - Farmington- Site Number : 8401115
- Florida
  - Coral Gables, Florida, United States, 33146
    - Pediatric Skin Research- Site Number : 8401198
  - Doral, Florida, United States, 33172
    - St. Jude Clinical Research- Site Number : 8401287
  - Fort Myers, Florida, United States, 33919
    - Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286
  - Hialeah, Florida, United States, 33012
    - Direct Helpers Research Center- Site Number : 8401056
  - Hollywood, Florida, United States, 33024
    - Encore Medical Research - Hollywood- Site Number : 8401030
  - Miami, Florida, United States, 33126
    - Clever Medical Research- Site Number : 8401160
  - Miami, Florida, United States, 33142
    - Acevedo Clinical Research Associates- Site Number : 8401088
  - Miami, Florida, United States, 33173
    - Florida International Research Center- Site Number : 8401091
  - Miami, Florida, United States, 33176
    - Anchor Medical Research- Site Number : 8401300
  - Miami, Florida, United States, 33173
    - Miami Dermatology and Laser Research - Miami - Southwest 87th Avenue- Site Number : 8401086
  - Miami Lakes, Florida, United States, 33014
    - Savin Medical Group - Miami Lakes- Site Number : 8401085
  - Pompano Beach, Florida, United States, 33060
    - Nuline Clinical Trial Center- Site Number : 8401161
  - St. Petersburg, Florida, United States, 33705
    - Global Clinical Professionals (GCP)- Site Number : 8401045
  - Tampa, Florida, United States, 33607
    - Clinical Research Trials of Florida- Site Number : 8401023
- Georgia
  - Columbus, Georgia, United States, 31904
    - AllerVie Clinical Research - Columbus- Site Number : 8401104
  - Dawsonville, Georgia, United States, 30534
    - Cleaver Medical Group- Site Number : 8401138
  - Fayetteville, Georgia, United States, 30214
    - First Georgia Physician Group- Site Number : 8401190
  - Macon, Georgia, United States, 31217
    - Skin Care Physicians of Georgia - Macon- Site Number : 8401034
  - Thomasville, Georgia, United States, 31792
    - Javara Research - Thomasville- Site Number : 8401189
  - Union City, Georgia, United States, 30291
    - Rophe Adult & Pediatric Medicine- Site Number : 8401289
- Illinois
  - Skokie, Illinois, United States, 60077
    - NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038
- Indiana
  - Indianapolis, Indiana, United States, 46256
    - Dawes Fretzin Clinical Research- Site Number : 8401015
- Kentucky
  - Bowling Green, Kentucky, United States, 42104
    - Equity Medical - Bowling Green- Site Number : 8401296
  - Louisville, Kentucky, United States, 40217
    - Skin Sciences- Site Number : 8401039
- Louisiana
  - Covington, Louisiana, United States, 70433
    - MedPharmics - Covington- Site Number : 8401137
  - Gretna, Louisiana, United States, 70053
    - BRCR Global Gretna- Site Number : 8401243
  - Lafayette, Louisiana, United States, 70508
    - Velocity Clinical Research - Lafayette- Site Number : 8401152
- Massachusetts
  - Brighton, Massachusetts, United States, 02135
    - MetroBoston Clinical Partners - Brighton- Site Number : 8401128
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital- Site Number : 8401044
  - Troy, Michigan, United States, 48085
    - Oakland Medical Center- Site Number : 8401116
  - Troy, Michigan, United States, 48084
    - Revival Research Institute - Troy- Site Number : 8401012
  - Ypsilanti, Michigan, United States, 48197
    - Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078
- Mississippi
  - Ridgeland, Mississippi, United States, 39157
    - SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058
- Nebraska
  - Omaha, Nebraska, United States, 68144
    - Skin Specialists- Site Number : 8401068
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Jubilee Clinical Research- Site Number : 8401054
- New Jersey
  - Hoboken, New Jersey, United States, 07030
    - Care Access - Hoboken- Site Number : 8401132
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - The University of New Mexico- Site Number : 8401263
- New York
  - New York, New York, United States, 10023
    - Equity Medical- Site Number : 8401239
  - New York, New York, United States, 10029
    - Icahn School of Medicine at Mount Sinai- Site Number : 8401129
  - New York, New York, United States, 10128
    - OptiSkin- Site Number : 8401163
  - New York, New York, United States, 10075
    - Sadick Research Group - New York - Park Avenue- Site Number : 8401050
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - AXIS Clinicals - Fargo- Site Number : 8401196
- Ohio
  - Bexley, Ohio, United States, 43209
    - Bexley Dermatology Research- Site Number : 8401051
  - Mayfield Heights, Ohio, United States, 44124
    - Apex Clinical Research Center- Site Number : 8401237
- Oregon
  - Portland, Oregon, United States, 97201
    - Oregon Medical Research Center- Site Number : 8401017
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - Best Skin Research - Camp Hill- Site Number : 8401031
  - Philadelphia, Pennsylvania, United States, 19103
    - Paddington Testing Company- Site Number : 8401041
  - Philadelphia, Pennsylvania, United States, 19114
    - Clinical Research of Philadelphia- Site Number : 8401193
  - Plymouth Meeting, Pennsylvania, United States, 19462
    - Dermatology Associates of Plymouth Meeting- Site Number : 8401147
- South Carolina
  - Columbia, South Carolina, United States, 29212
    - Columbia Dermatology & Aesthetics- Site Number : 8401166
  - Greenville, South Carolina, United States, 29607
    - Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8401225
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Health Concepts- Site Number : 8401059
- Texas
  - Arlington, Texas, United States, 76011
    - Arlington Research Center- Site Number : 8401248
  - Dallas, Texas, United States, 75230
    - Dermatology Treatment and Research Center- Site Number : 8401164
  - Dallas, Texas, United States, 75235
    - Derm Texas- Site Number : 8401217
  - Houston, Texas, United States, 77054
    - Prolato Clinical Research Center- Site Number : 8401209
  - Mesquite, Texas, United States, 75149
    - SMS Clinical Research- Site Number : 8401182
  - Missouri City, Texas, United States, 77459
    - Synapse Clinical Research - Missouri City- Site Number : 8401148
  - San Antonio, Texas, United States, 78218
    - Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8401131
  - Southlake, Texas, United States, 76092
    - Stryde Research - Epiphany Dermatology- Site Number : 8401185
  - Sugar Land, Texas, United States, 77479
    - Complete Dermatology - Sugar Land- Site Number : 8401061
- Utah
  - Layton, Utah, United States, 84041
    - Tanner Clinic - Layton Antelope A- Site Number : 8401151
- Virginia
  - Arlington, Virginia, United States, 22206
    - Care Access - Arlington- Site Number : 8401134
  - Norfolk, Virginia, United States, 23502
    - Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amlitelimab dose 1 Subcutaneous injection as per protocol	Drug: Amlitelimab Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection Other Names: SAR445229
Experimental: Amlitelimab dose 2 Subcutaneous injection as per protocol	Drug: Amlitelimab Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection Other Names: SAR445229
Placebo Comparator: Placebo Subcutaneous injection as per protocol	Drug: Placebo Pharmaceutical form: Injection solution Route of administration: SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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".	Week 24
EU, EU Reference Countries, and Japan: Proportion of participants who maintain treatment response in ESTUARY without experiencing relapse Time Frame: Week 48	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".	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who continue to be EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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).	Up to Week 48
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 Time Frame: Up to Week 48	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.	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants who maintain treatment response without experiencing relapse Time Frame: Up to Week 48	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.	Up to Week 48
Percent change in EASI from parent study baseline Time Frame: Parent study baseline to Week 48	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.	Parent study baseline to Week 48
Proportion of participants who maintained EASI-75^ without experiencing relapse among the participants who met EASI-75^ at baseline of ESTUARY Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants with EASI-75^ Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants who continue to be EASI-90^ among the participants who met EASI-90^ at baseline of ESTUARY Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants with EASI-90^ Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants with vIGA-AD 0 or 1 Time Frame: Up to Week 48	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).	Up to Week 48
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) Time Frame: Up to Week 48	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).	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants with weekly average of daily PP-NRS reduction of ≥4^ Time Frame: Parent study baseline to Week 48	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".	Parent study baseline to Week 48
Proportion of participants who maintain PP-NRS ≤4 among participants who were PP-NRS ≤4 at baseline of ESTUARY Time Frame: Up to Week 48	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.	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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.	Up to Week 48
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) Time Frame: Up to week 68		Up to week 68
Pharmacokinetic: Serum amlitelimab concentrations Time Frame: Up to Week 68		Up to Week 68
Incidence of antidrug antibodies (ADAs) of amlitelimab Time Frame: Up to Week 68		Up to Week 68
Pharmacokinetic: maximum plasma concentration (Cmax) Time Frame: Up to Week 68		Up to Week 68
Pharmacokinetic: AUC4W and AUC12W Time Frame: Up to Week 4 and 12	Cumulative area under the serum concentration curve over 4 weeks (AUC4W). Cumulative area under the serum concentration curve over 12 weeks (AUC12W).	Up to Week 4 and 12
Proportion of participants who are EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and did not relapse by Week 12 Time Frame: Up to Week 48	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".	Up to Week 48
Time to first recapture of EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants who recapture EASI-75^ by visit among the participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants who are EASI 90^ without experiencing relapse among participants who had EASI-90^ at baseline of ESTUARY Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants who are EASI-90^ among participants who had EASI-90^ at baseline of ESTUARY and did not relapse by Week 12. Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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).	Up to Week 48
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 Time Frame: Up to Week 48	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).	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: Up to Week 48	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.	Up to Week 48
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 Time Frame: Up to Week 48	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.	Up to Week 48
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 Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants who maintain PP NRS ≤4 without experiencing relapse among participants who had PP-NRS ≤4 at baseline of ESTUARY Time Frame: Up to Week 48	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".	Up to Week 48
Proportion of participants who achieve PP-NRS reduction of ≥4 Time Frame: Up to Week 48	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.	Up to Week 48
Proportion of participants who achieve PP-NRS ≤4 Time Frame: Up to Week 48	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.	Up to Week 48
Duration of maintained response without relapse Time Frame: Up to Week 48	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".	Up to Week 48
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 Time Frame: From parent study baseline to Week 48	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.	From parent study baseline to Week 48
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 Time Frame: From parent study baseline to Week 48	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"	From parent study baseline to Week 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 Time Frame: From parent study baseline to Week 48	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"	From parent study baseline to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

EFC17600 Plain Language Results Summary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Estimated)

June 29, 2026

Study Completion (Estimated)

March 17, 2027

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

EFC17600
U1111-1290-9215 (Registry Identifier: ICTRP)
2023-508096-36 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

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Phase

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Ages Eligible for Study

Accepts Healthy Volunteers

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Intervention / Treatment

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Primary Outcome Measures

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Study record dates

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First Submitted

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Study Record Updates

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Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Amlitelimab

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