Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (RIVER-AD)

June 2, 2026 updated by: Sanofi

A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.

This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis.

The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline.

Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.

Study Overview

Status

Enrolling by invitation

Conditions

Dermatitis Atopic

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1663

Phase

Phase 2
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, 1426
    - Investigational Site Number : 0320019
  - Buenos Aires, Argentina, 1427
    - Investigational Site Number : 0320005
  - Corrientes, Argentina, 3400
    - Investigational Site Number : 0320012
  - Córdoba, Argentina, 5000
    - Investigational Site Number : 0320014
  - Mendoza, Argentina, 5500
    - Investigational Site Number : 0320013
- Buenos Aires
  - Berazategui, Buenos Aires, Argentina, 1886
    - Investigational Site Number : 0320021
- 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, T4000
    - 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
  - Carlton, Victoria, Australia, 3053
    - Investigational Site Number : 0363002
  - Melbourne, Victoria, Australia, 3004
    - Investigational Site Number : 0360006
  - Melbourne, Victoria, Australia, 3002
    - Investigational Site Number : 0363003
  - Parkville, Victoria, Australia, 3050
    - Investigational Site Number : 0363001
  - 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
- Paraná
  - Curitiba, Paraná, Brazil, 80230-130
    - PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023
- 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, 1592
    - Investigational Site Number : 1002006
  - Sofia, Bulgaria, 1431
    - Investigational Site Number : 1002005
  - Sofia, Bulgaria, 1463
    - Investigational Site Number : 1002003
  - Sofia, Bulgaria, 1784
    - Investigational Site Number : 1002002
Canada
- Alberta
  - Calgary, Alberta, Canada, T2J 7E1
    - Investigational Site Number : 1240039
  - Calgary, Alberta, Canada, T2W 4X9
    - Investigational Site Number : 1240019
  - Calgary, Alberta, Canada, T3A 2N1
    - Investigational Site Number : 1240023
  - Edmonton, Alberta, Canada, T5K 2V4
    - Investigational Site Number : 1240031
  - Edmonton, Alberta, Canada, T5J 3S9
    - Investigational Site Number : 1240016
  - Red Deer, Alberta, Canada, T4P 1K4
    - Investigational Site Number : 1240045
- British Columbia
  - 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
  - Barrie, Ontario, Canada, L4M 7G1
    - Investigational Site Number : 1240014
  - Hamilton, Ontario, Canada, L8L 3C3
    - Investigational Site Number : 1240020
  - London, Ontario, Canada, N6H 5L5
    - Investigational Site Number : 1240017
  - London, Ontario, Canada, L6A 2C2
    - Investigational Site Number : 1240029
  - London, Ontario, Canada, N6A 5R9
    - Investigational Site Number : 1240053
  - Markham, Ontario, Canada, L3P 1X2
    - Investigational Site Number : 1241106
  - Mississauga, Ontario, Canada, L4Y 4C5
    - Investigational Site Number : 1240008
  - Newmarket, Ontario, Canada, L3Y 9E5
    - Investigational Site Number : 1240018
  - 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
  - Richmond Hill, Ontario, Canada, L4B 1A5
    - Investigational Site Number : 1240024
  - Toronto, Ontario, Canada, M3H 5Y8
    - Investigational Site Number : 1240012
  - Toronto, Ontario, Canada, M2N 3A6
    - Investigational Site Number : 1240021
  - Toronto, Ontario, Canada, M4E 1R7
    - Investigational Site Number : 1240026
  - Toronto, Ontario, Canada, M5A 3R6
    - Investigational Site Number: 1240035
  - Waterloo, Ontario, Canada, N2J 1C4
    - Investigational Site Number : 1241107
  - Windsor, Ontario, Canada, N8W 1E6
    - Investigational Site Number : 1241101
- 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 Lagos Region
  - Osorno, Los Lagos Region, Chile, 5311523
    - Investigational Site Number : 1520009
- Los Ríos Region
  - Valdivia, Los Ríos Region, Chile, 5110683
    - Investigational Site Number : 1520004
- Reg Metropolitana de Santiago
  - 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, 7750495
    - 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
  - Chongqing, China, 400016
    - Investigational Site Number : 1560057
  - 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
  - Guangzhou, China, 510100
    - Investigational Site Number : 1560036
  - 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
  - Nanchang, China, 330001
    - Investigational Site Number : 1560051
  - Ningbo, China, 315010
    - Investigational Site Number : 1560024
  - Ningbo, China, 315010
    - Investigational Site Number : 1560035
  - 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
  - Wuhan, China, 430030
    - Investigational Site Number : 1560038
  - Wuxi, China, 214000
    - Investigational Site Number : 1560003
  - Xi'an, China, 710004
    - Investigational Site Number : 1560032
  - Zhenjiang, China, 212000
    - Investigational Site Number : 1560028
Czechia
- - Brno, Czechia, 602 00
    - Investigational Site Number : 2032108
  - Kutná Hora, Czechia, 284 01
    - Investigational Site Number : 2032106
  - Nový Jičín, Czechia, 741 01
    - 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, 110 00
    - Investigational Site Number : 2030008
  - Prague, Czechia, 150 00
    - Investigational Site Number : 2030011
  - Prague, Czechia, 160 00
    - Investigational Site Number : 2030006
  - Prague, Czechia, 100 00
    - Investigational Site Number : 2032102
  - Prague, Czechia, 120 00
    - Investigational Site Number : 2032101
  - Prague, Czechia, 130 00
    - Investigational Site Number : 2032103
Denmark
- - Aarhus, Denmark, 8200
    - Investigational Site Number : 2080001
  - Herlev, Denmark, 2730
    - Investigational Site Number : 2080003
France
- - Antony, France, 92160
    - Investigational Site Number : 2500008
  - Bordeaux, France, 33000
    - Investigational Site Number : 2500011
  - Clermont-Ferrand, France, 63100
    - Investigational Site Number : 2500014
  - Lille, France, 59037
    - Investigational Site Number : 2500001
  - Nice, France, 06202
    - Investigational Site Number : 2500013
  - Reims, France, 51100
    - Investigational Site Number : 2500007
  - 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
  - Berlin, Germany, 10117
    - Investigational Site Number : 2762203
  - Blankenfelde-Mahlow, Germany, 15831
    - Investigational Site Number : 2762202
  - Dresden, Germany, 01307
    - Investigational Site Number : 2761001
  - Gera, Germany, 07548
    - Investigational Site Number : 2762207
  - Hamburg, Germany, 20095
    - Investigational Site Number : 2760017
  - Hamburg, Germany, 20354
    - Investigational Site Number : 2760021
  - Kiel, Germany, 24105
    - Investigational Site Number : 2762208
  - Lübeck, Germany, 23562
    - Investigational Site Number : 2761002
  - Mainz, Germany, 55128
    - Investigational Site Number : 2760016
  - Münster, Germany, 48149
    - Investigational Site Number : 2762201
Greece
- - Athens, Greece, 16121
    - Investigational Site Number : 3000001
  - Thessaloniki, Greece, 54643
    - Investigational Site Number : 3000002
Hungary
- - Debrecen, Hungary, 4032
    - Investigational Site Number : 3482303
  - Szolnok, Hungary, 5000
    - Investigational Site Number : 3482306
India
- - Ahmedabad, India, 380016
    - Investigational Site Number : 3560001
  - Belagavi, India, 590002
    - Investigational Site Number : 3560005
  - Chandigarh, India, 160012
    - Investigational Site Number : 3560004
  - 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
  - Jerusalem, Israel, 9112001
    - Investigational Site Number : 3760003
  - Petah Tikva, Israel, 4941492
    - Investigational Site Number : 3760002
  - Petah Tikva, Israel, 4920235
    - Investigational Site Number : 3760006
  - Ramat Gan, Israel, 5262100
    - Investigational Site Number : 3760008
  - Tel Aviv, Israel, 6423906
    - Investigational Site Number : 3760007
Italy
- - Bologna, Italy, 40138
    - Investigational Site Number : 3800012
  - Catania, Italy, 95123
    - Investigational Site Number : 3800009
  - Chieti, Italy, 66100
    - Investigational Site Number : 3800016
  - L’Aquila, Italy, 67100
    - Investigational Site Number : 3800011
  - Modena, Italy, 41125
    - Investigational Site Number : 3800021
  - Perugia, Italy, 06156
    - Investigational Site Number : 3800015
  - Pisa, Italy, 56126
    - Investigational Site Number : 3800008
- Milano
  - Milan, Milano, Italy, 20122
    - Investigational Site Number : 3800003
  - Rozzano, Milano, Italy, 20089
    - Investigational Site Number : 3800018
- Napoli
  - Naples, Napoli, Italy, 80131
    - Investigational Site Number : 3800017
- Roma
  - Rome, Roma, Italy, 00133
    - Investigational Site Number : 3800013
- Torino
  - Turin, Torino, Italy, 10126
    - Investigational Site Number : 3800020
Japan
- - Hiroshima, Japan, 734-8551
    - Investigational Site Number : 3920007
  - Kagoshima, Japan, 890-0063
    - Investigational Site Number : 3923108
  - Kyoto, Japan, 606-8507
    - Investigational Site Number : 3920003
  - Kyoto, Japan, 602-8566
    - Investigational Site Number : 3923102
  - Tokyo, Japan, 120-0034
    - Investigational Site Number : 3923112
  - Yokohama, Japan, 221-0825
    - Investigational Site Number : 3923113
- 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
  - Sapporo, Hokkaido, Japan, 060-0063
    - Investigational Site Number : 3923101
- 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
- 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
  - Chūō, Tokyo, Japan, 103-0028
    - Investigational Site Number : 3923115
  - Edogawa City, Tokyo, Japan, 133-0052
    - Investigational Site Number : 3923104
  - Minato, Tokyo, Japan, 108-0014
    - Investigational Site Number : 3923107
  - Setagaya City, Tokyo, Japan, 158-0097
    - Investigational Site Number : 3923105
  - Tachikawa, Tokyo, Japan, 190-0023
    - Investigational Site Number : 3920001
Mexico
- - Durango, Mexico, 34000
    - Investigational Site Number : 4840009
  - Veracruz, Mexico, 91900
    - Investigational Site Number : 4840003
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64718
    - Investigational Site Number : 4840005
Poland
- Kuyavian-Pomeranian Voivodeship
  - Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
    - Investigational Site Number : 6162412
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 31-209
    - Investigational Site Number : 6162406
  - Krakow, Lesser Poland Voivodeship, Poland, 31-011
    - Investigational Site Number : 6162409
  - Krakow, Lesser Poland Voivodeship, Poland, 30-510
    - Investigational Site Number : 6162407
  - Krakow, Lesser Poland Voivodeship, Poland, 30-033
    - Investigational Site Number : 6162408
  - Tarnów, Lesser Poland Voivodeship, Poland, 33-100
    - Investigational Site Number: 6160010
- Lower Silesian Voivodeship
  - Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
    - Investigational Site Number : 6162414
  - Wroclaw, Lower Silesian Voivodeship, Poland, 51-685
    - Investigational Site Number : 6162417
  - Wroclaw, Lower Silesian Voivodeship, Poland, 51-318
    - Investigational Site Number : 6162418
- Lublin Voivodeship
  - Lublin, Lublin Voivodeship, Poland, 20-607
    - Investigational Site Number: 6160004
- Lódzkie
  - Lodz, Lódzkie, Poland, 90-127
    - Investigational Site Number : 6162415
  - Lodz, Lódzkie, Poland, 90-265
    - Investigational Site Number : 6160022
  - Lodz, Lódzkie, Poland, 90-436
    - Investigational Site Number : 6162416
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 01-142
    - Investigational Site Number : 6162411
  - Warsaw, Masovian Voivodeship, Poland, 01-192
    - Investigational Site Number : 6162413
  - Warsaw, Masovian Voivodeship, Poland, 02-625
    - Investigational Site Number: 6160009
  - Warsaw, Masovian Voivodeship, Poland, 02-962
    - Investigational Site Number: 6160007
- Podkarpackie Voivodeship
  - Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
    - Investigational Site Number : 6162401
- Podlaskie Voivodeship
  - Bialystok, Podlaskie Voivodeship, Poland, 15-879
    - Investigational Site Number : 6162419
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Poland, 80-546
    - Investigational Site Number : 6160006
  - Gdansk, Pomeranian Voivodeship, Poland, 80-382
    - Investigational Site Number : 6162402
  - Gdansk, Pomeranian Voivodeship, Poland, 80-952
    - Investigational Site Number : 6162403
  - Gdynia, Pomeranian Voivodeship, Poland, 81-537
    - Investigational Site Number : 6162404
- Silesian Voivodeship
  - Katowice, Silesian Voivodeship, Poland, 40-040
    - Investigational Site Number : 6162405
  - Katowice, Silesian Voivodeship, Poland, 40-611
    - Investigational Site Number: 6160003
- West Pomeranian Voivodeship
  - Szczecin, West Pomeranian Voivodeship, Poland, 71-500
    - Investigational Site Number : 6162410
Portugal
- - Lisbon, Portugal, 1649-035
    - Investigational Site Number : 6200004
  - Lisbon, Portugal, 1998-018
    - Investigational Site Number : 6200001
  - Porto, Portugal, 4099-001
    - Investigational Site Number : 6200003
Saudi Arabia
- - Riyadh, Saudi Arabia, 12713
    - Investigational Site Number : 6820001
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
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
  - Córdoba, Spain, 14004
    - Investigational Site Number : 7242501
  - Granada, Spain, 18014
    - Investigational Site Number : 7240018
  - Granada, Spain, 18016
    - Investigational Site Number : 7240019
  - Madrid, Spain, 28046
    - Investigational Site Number : 7242503
- Barcelona [Barcelona]
  - Badalona, Barcelona [Barcelona], Spain, 08916
    - Investigational Site Number : 7240002
- Basque Country
  - Bilbao, Basque Country, Spain, 48013
    - Investigational Site Number : 7240008
- Canary Islands
  - Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
    - Investigational Site Number : 7240012
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Investigational Site Number : 7240015
- Pontevedra [Pontevedra]
  - Pontevedra, Pontevedra [Pontevedra], Spain, 36002
    - Investigational Site Number : 7242504
  - Vigo, Pontevedra [Pontevedra], Spain, 36206
    - Investigational Site Number : 7240014
- Sevilla
  - Seville, Sevilla, Spain, 41013
    - Investigational Site Number : 7240020
- Valencia
  - Burjassot, Valencia, Spain, 46100
    - Investigational Site Number : 7240023
Taiwan
- - Kaohsiung City, Taiwan, 833
    - Investigational Site Number : 1583201
  - Taichung, Taiwan, 402
    - Investigational Site Number : 1583202
  - Taipei, Taiwan, 112
    - Investigational Site Number : 1580003
  - Taipei, Taiwan, 10016
    - Investigational Site Number : 1580001
  - Taoyuan City, Taiwan, 333
    - Investigational Site Number : 1583203
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), 34662
    - Investigational Site Number : 7920009
  - Kayseri, Turkey (Türkiye), 38039
    - Investigational Site Number : 7920004
United Arab Emirates
- - Abu Dhabi, United Arab Emirates, 4167
    - Investigational Site Number : 7840001
  - Abu Dhabi, United Arab Emirates, 51900
    - Investigational Site Number : 7841002
United Kingdom
- - Liverpool, United Kingdom, L7 8XP
    - Investigational Site Number : 8260008
- Bristol, City of
  - Bristol, Bristol, City of, United Kingdom, BS2 8HW
    - Investigational Site Number : 8260013
- England
  - London, England, United Kingdom, E11 1NR
    - Investigational Site Number : 8262603
- Glasgow City
  - Glasgow, Glasgow City, United Kingdom, G12 0YN
    - Investigational Site Number : 8260006
- Hampshire
  - Portsmouth, Hampshire, United Kingdom, PO3 6DW
    - Investigational Site Number : 8260003
- Leicestershire
  - Leicester, Leicestershire, United Kingdom, LE1 5WW
    - 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 7eh
    - Investigational Site Number : 8260016
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG17 4JL
    - Investigational Site Number : 8260010
United States
- Alabama
  - Birmingham, Alabama, United States, 35244
    - Cahaba Dermatology & Skin Health Center- Site Number : 8401066
  - Birmingham, Alabama, United States, 35209
    - Allervie Clinical Research - Birmingham- Site Number : 8401101
- 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
  - North Little Rock, Arkansas, United States, 72217
    - Arkansas Research Trials- Site Number : 8401244
- California
  - Anaheim, California, United States, 92801
    - Orange County Clinical Trials- Site Number : 8401271
  - 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
  - Lancaster, California, United States, 93534
    - Antelope Valley Clinical Trials- Site Number : 8401099
  - Lomita, California, United States, 90717
    - Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027
  - Long Beach, California, United States, 90806
    - Long Beach Clinical Trials- Site Number : 8401188
  - 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
  - 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
- Colorado
  - Wheat Ridge, Colorado, United States, 80033
    - Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245
- Connecticut
  - Farmington, Connecticut, United States, 06030
    - UConn Health - Farmington- Site Number : 8401115
- Florida
  - Boynton Beach, Florida, United States, 33436
    - Encore Medical Research of Boynton Beach- Site Number : 8401030
  - 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
  - Fort Myers, Florida, United States, 33912
    - Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111
  - Hialeah, Florida, United States, 33012
    - Direct Helpers Research Center- Site Number : 8401056
  - Hialeah, Florida, United States, 33016
    - Doral Medical Research - Hialeah- Site Number : 8401094
  - Jacksonville, Florida, United States, 32256
    - Apex Clinical Research - Jacksonville- Site Number : 8401332
  - 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, 33142
    - Future Care Solution - Miami- Site Number : 8401144
  - Miami, Florida, United States, 33157
    - Sanchez Clinical Research- Site Number : 8401095
  - Miami, Florida, United States, 33134
    - Medical Research Center of Miami II- Site Number : 8401019
  - Miami, Florida, United States, 33133
    - Miami Dermatology and Laser Research - Miami - South Miami Avenue- Site Number : 8401086
  - Miami Lakes, Florida, United States, 33014
    - Savin Medical Group - Miami Lakes- Site Number : 8401085
  - Miami Lakes, Florida, United States, 33016
    - Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8401109
  - Orlando, Florida, United States, 32806
    - K2 South Orlando - South Orange Avenue- Site Number : 8401268
  - Pompano Beach, Florida, United States, 33060
    - Nuline Clinical Trial Center- Site Number : 8401161
  - St. Petersburg, Florida, United States, 33714
    - Global Clinical Professionals (GCP)- Site Number : 8401045
  - Tampa, Florida, United States, 33607
    - Clinical Research Trials of Florida- Site Number : 8401023
  - Tampa, Florida, United States, 33615
    - Alliance Clinical Research of Tampa- Site Number : 8401013
- Georgia
  - Dawsonville, Georgia, United States, 30534
    - Cleaver Medical Group- Site Number : 8401138
  - Fayetteville, Georgia, United States, 30214
    - First Georgia Physician Group- Site Number : 8401190
  - Savannah, Georgia, United States, 31406
    - Aeroallergy Research Laboratory- Site Number : 8401004
  - 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
  - Chicago, Illinois, United States, 60611
    - Northwestern University- 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
  - Baton Rouge, Louisiana, United States, 70809
    - Velocity Clinical Research at The Dermatology Clinic - Baton Rouge- Site Number : 8401072
  - 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
  - Henderson, Nevada, United States, 89052
    - Pulmonology Group - Henderson- Site Number : 8401169
  - Las Vegas, Nevada, United States, 89106
    - Jubilee Clinical Research- Site Number : 8401054
- New Jersey
  - East Windsor, New Jersey, United States, 08520
    - Schweiger Dermatology Group - East Windsor- Site Number : 8401338
  - 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, 10128
    - OptiSkin- Site Number : 8401163
  - New York, New York, United States, 10075
    - Sadick Research Group - New York - Park Avenue- Site Number : 8401050
  - Rochester, New York, United States, 14623
    - Skin Search Rochester- Site Number : 8401216
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - AXIS Clinicals - Fargo- Site Number : 8401196
- Ohio
  - Mayfield Heights, Ohio, United States, 44124
    - Apex Clinical Research Center- Site Number : 8401237
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health & Science University (OHSU)- Site Number : 8401247
- 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
  - Columbia, South Carolina, United States, 29204
    - Velocity Clinical Research - Columbia- Site Number : 8401176
- 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, 75231
    - Modern Research Associates- Site Number : 8401093
  - Dallas, Texas, United States, 75235
    - Reveal Research Institute - Dallas- Site Number : 8401219
  - 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
  - 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
- Wyoming
  - Cheyenne, Wyoming, United States, 82001
    - Wyoming Research Foundation- Site Number : 8401234

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

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participant must be at least 12 years of age inclusive at the time of signing the informed consent.
Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period.
- Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600
- Participants in DRI17366 must only be enrolled from 1 of the following 3 groups:
  - The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2.
  - The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52.
  - The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up.
- Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit
Complied with the previous clinical trial protocol to the satisfaction of the investigator
Body weight must be ≥25 kg
Provided signed informed assent/or consent and able to comply with the requirements of the protocol 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 the section for permanent discontinuation of the feeder study or LTS17367 protocol
Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
History of solid organ or stem cell transplant
Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline)
Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA PCR test
History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to screening
Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met:
1. Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection
2. Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant
3. For whom review and approval from Sponsor have been granted are eligible
Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment
Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments
In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis

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: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amlitelimab dose level 1 Subcutaneous injection as per protocol	Drug: Amlitelimab Pharmaceutical form: Solution for injection Route of administration: Subcutaneous Other Names: SAR445229 Drug: Topical corticosteroids Pharmaceutical form: Topical Route of administration: Topical Drug: Topical calcineurin inhibitors Pharmaceutical form: Topical Route of administration: Topical Drug: Oral corticosteroids Pharmaceutical form: Oral Route of administration: Oral
Experimental: Amlitelimab dose level 2 Subcutaneous injection as per protocol	Drug: Amlitelimab Pharmaceutical form: Solution for injection Route of administration: Subcutaneous Other Names: SAR445229 Drug: Topical corticosteroids Pharmaceutical form: Topical Route of administration: Topical Drug: Topical calcineurin inhibitors Pharmaceutical form: Topical Route of administration: Topical Drug: Oral corticosteroids Pharmaceutical form: Oral Route of administration: Oral

Participant Group / Arm

Intervention / Treatment

Experimental: Amlitelimab dose level 1

Subcutaneous injection as per protocol

Drug: Amlitelimab

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Other Names:

SAR445229

Drug: Topical corticosteroids

Pharmaceutical form: Topical Route of administration: Topical

Drug: Topical calcineurin inhibitors

Pharmaceutical form: Topical Route of administration: Topical

Drug: Oral corticosteroids

Pharmaceutical form: Oral Route of administration: Oral

Experimental: Amlitelimab dose level 2

Subcutaneous injection as per protocol

Drug: Amlitelimab

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Other Names:

SAR445229

Drug: Topical corticosteroids

Pharmaceutical form: Topical Route of administration: Topical

Drug: Topical calcineurin inhibitors

Pharmaceutical form: Topical Route of administration: Topical

Drug: Oral corticosteroids

Pharmaceutical form: Oral Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants who experienced treatment-emergent adverse event (TEAE) Time Frame: Baseline to Week 332	Baseline to Week 332

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who experienced treatment-emergent serious adverse events (SAEs) Time Frame: Baseline to Week 332		Baseline to Week 332
Percentage of participants who experienced TEAE leading to treatment discontinuation Time Frame: Baseline to Week 332		Baseline to Week 332
Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24 Time Frame: DRI17366 Baseline to Week 332	EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.	DRI17366 Baseline to Week 332
Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24 Time Frame: DRI17366 Baseline to Week 332	EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.	DRI17366 Baseline to Week 332
Serum amlitelimab concentration assessed at prespecified time points through the end of the study Time Frame: Baseline to Week 332	Serum amlitelimab concentration assessed at prespecified time points through the end of the study.	Baseline to Week 332
Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI) Time Frame: Baseline to Week 332		Baseline to Week 332
Proportion of participants with EASI50/EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24 Time Frame: DRI17366 Baseline to Week 332	EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI50: >= 50% reduction in score from baseline; EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.	DRI17366 Baseline to Week 332
Proportion of participants with a response of Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24 Time Frame: Baseline to Week 332	The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	Baseline to Week 332
Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit] Time Frame: Baseline to Week 332	The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	Baseline to Week 332
Proportion of participants with vIGA-AD score 0 [each LTS17367 visit] Time Frame: Baseline to Week 332	The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	Baseline to Week 332
Proportion of participants with vIGA-AD score 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit Time Frame: Baseline to Week 332	The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	Baseline to Week 332
Time to first vIGA-AD 0/1 after LTS17367 enrollment in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 enrollment Time Frame: Baseline to Week 332	The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	Baseline to Week 332
Absolute change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit] Time Frame: Baseline to Week 332	EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.	Baseline to Week 332
Percent change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit] Time Frame: Baseline to Week 332	EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.	Baseline to Week 332
Proportion of participants with EASI50/EASI75/EASI90 in all participants entering the study [each LTS17367 visit] Time Frame: Baseline to Week 332	EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI50: >= 50% reduction in score from baseline; EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline.	Baseline to Week 332
Time to first EASI75/EASI90 in those participants who had not achieved it by the time of LTS17367 enrollment Time Frame: Baseline to Week 332	EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline.	Baseline to Week 332
Proportion of participants requiring topical treatment in all participants entering the study [each LTS17367 visit] Time Frame: Baseline to Week 332		Baseline to Week 332
Proportion of participants requiring rescue treatment [each LTS17367 visit]: all treatments in all participants entering the study Time Frame: Baseline to Week 332		Baseline to Week 332
Number of days on topical medication (per patient-year) in all participants entering the study Time Frame: Baseline to Week 332		Baseline to Week 332
Change from feeder study baseline atopic dermatitis control tool (ADCT) in all participants entering the study [each LTS17367 visit] Time Frame: Baseline to Week 332	ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control. The score ranges from 0-24 with higher scores indicate worsening disease control.	Baseline to Week 332
Change from feeder study baseline in dermatology life quality index (DLQI/cDLQI) in all participants entering the study [each LTS17367 visit] Time Frame: Baseline to Week 332	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. The children's DLQI (cDLQI) measures dermatology specific quality of life (QoL) in children patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Baseline to Week 332
Change from feeder study baseline in patient oriented eczema measure (POEM) in all participants entering the study [each LTS17367 visit] Time Frame: Baseline to Week 332	The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.	Baseline to Week 332
Change from feeder study baseline in body surface area affected by AD (BSA-AD) [each LTS17367 visit] Time Frame: Baseline to Week 332	BSA-AD measured as percentage of body affected by AD.	Baseline to Week 332
Time from enrollment in LTS17367 to first loss of vIGA-AD 0 in those participants who were vIGA-AD 0 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA) Time Frame: Baseline to Week 332	The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	Baseline to Week 332
Time from enrollment in LTS17367 to first loss EASI75 in those participants who had reached EASI75 at LTS17367 rollover coming from EFC17600 (ESTUARY) and EFC17599 (AQUA) Time Frame: Baseline to Week 332	EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher indicated greater severity of AD. EASI75: >= 75% reduction in score from baseline.	Baseline to Week 332
Time from enrollment in LTS17367 to first loss of vIGA-AD 0/1 in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA) Time Frame: Baseline to Week 332	The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	Baseline to Week 332
Number of participants with anti-drug antibodies (ADAs) of amlitelimab at specified timepoints Time Frame: Baseline to Week 332		Baseline to Week 332
Time from LTS17367 baseline to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA) Time Frame: Baseline to Week 332	The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	Baseline to Week 332
Time from last amlitelimab dose in feeder study to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA) Time Frame: Baseline to Week 332	The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.	Baseline to Week 332

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

LTS17367 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)

August 22, 2022

Primary Completion (Estimated)

January 22, 2029

Study Completion (Estimated)

January 22, 2029

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

LTS17367
U1111-1269-6490 (Registry Identifier: ICTRP)
2021-002344-73 (EudraCT Number)
2023-506548-18 (Registry Identifier: CTIS)
KY1005-CT06 (Other Identifier: Sanofi Identifier)

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.

Clinical Trials on Dermatitis Atopic

Caja Costarricense de Seguro Social

Not yet recruiting

Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

Atopic Dermatitis | Atopic Dermatitis (Eczema) | Atopic Dermatitis (AD) | Atopic Dermatitis / Eczema | Atopic Dermatitis, Unspecified | Atopic Dermatitis Patients

Costa Rica
Alphyn Biologics

Recruiting

Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD. (CLEAR-AD1)

Eczema | Atopic Dermatitis | Atopic Dermatitis (Eczema) | Atopic Dermatitis Eczema | Eczema, Atopic | Atopic Dermatitis (AD)

Australia
En Chu Kong Hospital

Recruiting

Herbal Ointment in Treating Atopic Dermatitis Topically

Skin Diseases | Skin Diseases, Genetic | Skin Diseases, Eczematous | Atopic Dermatitis | Atopic Dermatitis (Eczema) | Atopic Dermatitis Eczema | Atopic Dermatitis (AD) | TCM

Taiwan
Catalysis SL

Completed

Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children

Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)

Serbia
Taipei Medical University Shuang Ho Hospital

Recruiting

Prebiotic Effects of Mulberry Fruit in Children and Adolescents With Atopic Dermatitis

Atopic Dermatitis (Eczema) | Atopic Dermatitis, Probiotics

Taiwan
Jacob Pontoppidan Thyssen
The Novo Nordic Foundation

Recruiting

Staphylococcus Aureus and The Skin Microbiome During Flare And Resolution Of Atopic Dermatitis

Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis Flare

Denmark
Apollo Therapeutics Ltd

Recruiting

A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis

Dermatitis | Eczema | Dermatitis, Atopic | Atopic Dermatitis | Atopic | Eczema, Atopic | Dermatologic Disease | Eczema Atopic Dermatitis

United States, Spain, Germany, Canada, Bulgaria, Poland, Czechia, Hungary
Pfizer

Terminated

A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection

Eczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, Unspecified

United States, Canada, Czechia, Poland
Corvus Pharmaceuticals, Inc.

Recruiting

Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD (SIERRA1)

Eczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Eczema, Atopic

United States
Evommune, Inc.

Completed

Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis

Eczema | Atopic Dermatitis (AD) | Eczema Atopic Dermatitis

New Zealand, Australia

Clinical Trials on Amlitelimab

Sanofi

Completed

A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants

Healthy Volunteers

United States
Sanofi

Completed

A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants

Healthy Volunteers

United States
Sanofi

Active, not recruiting

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis (ATLANTIS)

Dermatitis Atopic

Netherlands, Taiwan, Denmark, China, Australia, Italy, France, Czechia, South Africa, Argentina, Canada, Germany, Japan, Spain, Brazil, Chile, Poland, South Korea, United Kingdom, Mexico, United States, India, Puerto Rico, Switzerland, Turkey...
Sanofi

Active, not recruiting

Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study (RIVER-ASTHMA)

Asthma

Hungary, Italy, Mexico, Poland, South Africa, United Kingdom, Argentina, Japan, United States, Brazil, Canada, South Korea, Chile, Turkey (Türkiye)
Scleroderma Research Foundation, Inc.
Sanofi; Boehringer Ingelheim

Recruiting

Platform Clinical Study for Conquering Scleroderma (CONQUEST)

Scleroderma | Interstitial Lung Disease Due to Systemic Disease

United States
Sanofi

Completed

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

Dermatitis Atopic

Denmark, China, Czechia, Japan, United States, Bulgaria, Italy, Argentina, Mexico, Portugal, South Africa, Spain, Sweden, United Kingdom, Chile, Turkey (Türkiye)
Sanofi

Completed

Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma (TIDE-asthma)

Asthma

United States, Argentina, Brazil, Canada, Hungary, Italy, Japan, Mexico, Poland, South Africa, United Kingdom, Chile, South Korea, Turkey (Türkiye)
Sanofi

Active, not recruiting

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata

Alopecia Areata

Italy, Spain, China, France, United States, Argentina, Australia, Bulgaria, Canada, Czechia, Germany, Japan, Netherlands, United Kingdom, Chile, Romania
Sanofi

Terminated

Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis

Australia, Hungary, Spain, Germany, Poland, United States, Canada, France, Italy, Portugal, Chile
Sanofi

Active, not recruiting

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)

Dermatitis Atopic

Taiwan, Denmark, Israel, China, South Africa, Australia, France, Czechia, Japan, United States, Argentina, Brazil, Bulgaria, Canada, Germany, Italy, Spain, Greece, India, Mexico, Portugal, Sweden, United Kingdom, Chile, Turkey (Türkiye), ... and more

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (RIVER-AD)

A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

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

Clinical Trials on Dermatitis Atopic

Clinical Trials on Amlitelimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations