A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids
NCT ID: NCT06224348
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
643 participants
INTERVENTIONAL
2024-01-18
2025-11-01
Brief Summary
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The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI.
Study details include:
At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY).
For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up.
For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period.
The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Amlitelimab dose 1
Subcutaneous injection as per protocol
Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Topical corticosteroids
Pharmaceutical form: Topical formulation Route of administration: Topical
Topical calcineurin inhibitors
Pharmaceutical form: Topical formulation Route of administration: Topical
Amlitelimab dose 2
Subcutaneous injection as per protocol
Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Topical corticosteroids
Pharmaceutical form: Topical formulation Route of administration: Topical
Topical calcineurin inhibitors
Pharmaceutical form: Topical formulation Route of administration: Topical
Placebo
Subcutaneous injection as per protocol
Placebo
Pharmaceutical form: injection solution Route of administration: SC injection
Topical corticosteroids
Pharmaceutical form: Topical formulation Route of administration: Topical
Topical calcineurin inhibitors
Pharmaceutical form: Topical formulation Route of administration: Topical
Interventions
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Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Placebo
Pharmaceutical form: injection solution Route of administration: SC injection
Topical corticosteroids
Pharmaceutical form: Topical formulation Route of administration: Topical
Topical calcineurin inhibitors
Pharmaceutical form: Topical formulation Route of administration: Topical
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
* Documented history (within 6 months before screening) of inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
* v-IGA-AD of 3 or 4 at baseline visit
* EASI score of 16 or higher at baseline
* AD involvement of 10% or more of BSA at baseline
* Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
* Able and willing to comply with requested study visits and procedures
* Body weight ≥25 kg
Exclusion Criteria
* Skin co-morbidity that would adversely affect the ability to undertake AD assessments
* Known history of or suspected significant current immunosuppression
* Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \>5 years prior to baseline)
* History of solid organ or stem cell transplant
* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
* Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
* In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
* History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
12 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Cahaba Dermatology & Skin Health Center- Site Number : 8401066
Birmingham, Alabama, United States
Johnson Dermatology- Site Number : 8401076
Fort Smith, Arkansas, United States
Encino Research Center- Site Number : 8401042
Encino, California, United States
Marvel Clinical Research- Site Number : 8401102
Huntington Beach, California, United States
LA Universal Research Center- Site Number : 8401064
Los Angeles, California, United States
Cura Clinical Research- Site Number : 8401141
Palmdale, California, United States
Integrative Skin Science and Research- Site Number : 8401275
Sacramento, California, United States
Southern California Dermatology- Site Number : 8401043
Santa Ana, California, United States
Skin Care Research - Hollywood- Site Number : 8401071
Hollywood, Florida, United States
Clever Medical Research- Site Number : 8401160
Miami, Florida, United States
Acevedo Clinical Research Associates- Site Number : 8401088
Miami, Florida, United States
Palm Springs Community Health Center- Site Number : 8401264
Miami Lakes, Florida, United States
Global Clinical Professionals (GCP)- Site Number : 8401045
St. Petersburg, Florida, United States
University of South Florida- Site Number : 8401070
Tampa, Florida, United States
Avita Clinical Research- Site Number : 8401073
Tampa, Florida, United States
Cleaver Medical Group- Site Number : 8401138
Dawsonville, Georgia, United States
NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038
Skokie, Illinois, United States
Dawes Fretzin Clinical Research- Site Number : 8401015
Indianapolis, Indiana, United States
BRCR Global Gretna- Site Number : 8401243
Gretna, Louisiana, United States
Velocity Clinical Research - New Orleans- Site Number : 8401155
New Orleans, Louisiana, United States
Oakland Medical Center- Site Number : 8401116
Troy, Michigan, United States
Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078
Ypsilanti, Michigan, United States
Dermatology and Skin Cancer Lee's Summit- Site Number : 8401157
Lee's Summit, Missouri, United States
Skin Specialists- Site Number : 8401068
Omaha, Nebraska, United States
Jubilee Clinical Research- Site Number : 8401054
Las Vegas, Nevada, United States
Allcutis Research - Portsmouth- Site Number : 8401082
Portsmouth, New Hampshire, United States
Equity Medical- Site Number : 8401239
New York, New York, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8401129
New York, New York, United States
OptiSkin- Site Number : 8401163
New York, New York, United States
Apex Clinical Research Center- Site Number : 8401237
Mayfield Heights, Ohio, United States
Essential Medical Research- Site Number : 8401183
Tulsa, Oklahoma, United States
Vial Health - DermDox Dermatology- Site Number : 8401031
Camp Hill, Pennsylvania, United States
Clinical Research Center of the Carolinas- Site Number : 8401067
Charleston, South Carolina, United States
SMS Clinical Research- Site Number : 8401182
Mesquite, Texas, United States
Sienna Dermatology- Site Number : 8401148
Missouri City, Texas, United States
Texas Dermatology and Laser Specialists- Site Number : 8401131
San Antonio, Texas, United States
Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026
San Antonio, Texas, United States
Complete Dermatology - Sugar Land- Site Number : 8401061
Sugar Land, Texas, United States
Cope Family Medicine - Ogden Clinic- Site Number : 8401114
Bountiful, Utah, United States
Tanner Clinic - Layton Antelope A- Site Number : 8401151
Layton, Utah, United States
Investigational Site Number : 0320005
CABA, Buenos Aires F.D., Argentina
Investigational Site Number : 0320011
Buenos Aires, , Argentina
Investigational Site Number : 0320019
Buenos Aires, , Argentina
Investigational Site Number : 0320008
Buenos Aires, , Argentina
Investigational Site Number : 0320018
Buenos Aires, , Argentina
Investigational Site Number : 0320010
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Buenos Aires, , Argentina
Investigational Site Number : 0320012
Corrientes, , Argentina
Investigational Site Number : 0320013
Mendoza, , Argentina
Investigational Site Number : 0320020
San Miguel de Tucumán, , Argentina
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017
Vitória, Espírito Santo, Brazil
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
Salvador, Estado de Bahia, Brazil
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023
Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC- Site Number : 0760001
Santo André, , Brazil
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
São Paulo, , Brazil
Hospital das Clinicas FMUSP- Site Number : 0760012
São Paulo, , Brazil
Investigational Site Number : 1002007
Dupnitsa, , Bulgaria
Investigational Site Number : 1002004
Pleven, , Bulgaria
Investigational Site Number : 1002009
Sofia, , Bulgaria
Investigational Site Number : 1002006
Sofia, , Bulgaria
Investigational Site Number : 1240039
Calgary, Alberta, Canada
Investigational Site Number : 1240045
Red Deer, Alberta, Canada
Investigational Site Number : 1240046
Kamloops, British Columbia, Canada
Investigational Site Number : 1240030
Surrey, British Columbia, Canada
Investigational Site Number : 1240041
Winnipeg, Manitoba, Canada
Investigational Site Number : 1240057
Brampton, Ontario, Canada
Investigational Site Number : 1241106
Markham, Ontario, Canada
Investigational Site Number : 1240008
Mississauga, Ontario, Canada
Investigational Site Number : 1240004
Peterborough, Ontario, Canada
Investigational Site Number : 1240038
Richmond Hill, Ontario, Canada
Investigational Site Number : 1240012
Toronto, Ontario, Canada
Investigational Site Number : 1241107
Waterloo, Ontario, Canada
Investigational Site Number : 1240006
Québec, Quebec, Canada
Investigational Site Number : 1520009
Osorno, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520008
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520011
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520006
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1520010
Santiago, , Chile
Investigational Site Number : 1520012
Talcahuano, , Chile
Investigational Site Number : 1560050
Changsha, , China
Investigational Site Number : 1560060
Chengdu, , China
Investigational Site Number : 1560043
Fuzhou, , China
Investigational Site Number : 1560021
Guangzhou, , China
Investigational Site Number : 1560044
Hangzhou, , China
Investigational Site Number : 1560006
Hangzhou, , China
Investigational Site Number : 1560051
Nanchang, , China
Investigational Site Number : 1560005
Shanghai, , China
Investigational Site Number : 1560041
Shenyang, , China
Investigational Site Number : 1560047
Tianjin, , China
Investigational Site Number : 1560049
Wuhan, , China
Investigational Site Number : 1560003
Wuxi, , China
Investigational Site Number : 2032105
Nový Jičín, , Czechia
Investigational Site Number : 2030010
Olomouc, , Czechia
Investigational Site Number : 2032104
Ostrava, , Czechia
Investigational Site Number : 2030009
Pilsen, , Czechia
Investigational Site Number : 2030008
Prague, , Czechia
Investigational Site Number : 2030008
Prague, , Czechia
Investigational Site Number : 2030011
Prague, , Czechia
Investigational Site Number : 2500011
Bordeaux, , France
Investigational Site Number : 2500009
Nantes, , France
Investigational Site Number : 2500013
Nice, , France
Investigational Site Number : 2500006
Pierre-Bénite, , France
Investigational Site Number : 2500010
Romans-sur-Isère, , France
Investigational Site Number : 2500012
Rouen, , France
Investigational Site Number : 2500016
Saint-Pierre, , France
Investigational Site Number : 2500002
Toulouse, , France
Investigational Site Number : 2760020
Augsburg, , Germany
Investigational Site Number : 2760009
Bad Bentheim, , Germany
Investigational Site Number : 2760014
Buxtehude, , Germany
Investigational Site Number : 2760017
Hamburg, , Germany
Investigational Site Number : 2760021
Hamburg, , Germany
Investigational Site Number : 2762208
Kiel, , Germany
Investigational Site Number : 2760018
Magdeburg, , Germany
Investigational Site Number : 2760016
Mainz, , Germany
Investigational Site Number : 2762201
Münster, , Germany
Investigational Site Number : 2760019
Witten, , Germany
Investigational Site Number : 3800003
Milan, Lombardy, Italy
Investigational Site Number : 3800012
Bologna, , Italy
Investigational Site Number : 3800011
L’Aquila, , Italy
Investigational Site Number : 3800008
Pisa, , Italy
Investigational Site Number : 3800019
Torette, , Italy
Investigational Site Number : 3920009
Chitose, Hokkaido, Japan
Investigational Site Number : 3923114
Obihiro, Hokkaido, Japan
Investigational Site Number : 3920008
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920006
Kobe, Hyōgo, Japan
Investigational Site Number : 3920005
Sagamihara, Kanagawa, Japan
Investigational Site Number : 3923113
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920010
Miyagi-gun, Miyagi, Japan
Investigational Site Number : 3920011
Sendai, Miyagi, Japan
Investigational Site Number : 3923110
Sakai, Osaka, Japan
Investigational Site Number : 3920002
Iruma, Saitama, Japan
Investigational Site Number : 3923106
Mibu, Tochigi, Japan
Investigational Site Number : 3920004
Chūō, Tokyo, Japan
Investigational Site Number : 3923107
Minato, Tokyo, Japan
Investigational Site Number : 3920001
Tachikawa, Tokyo, Japan
Investigational Site Number : 3923109
Habikino, , Japan
Investigational Site Number : 3923108
Kagoshima, , Japan
Investigational Site Number : 3923102
Kyoto, , Japan
Investigational Site Number : 3920003
Kyoto, , Japan
Investigational Site Number : 3923113
Yokohama, , Japan
Investigational Site Number : 7240019
Granada, Andalusia, Spain
Investigational Site Number : 7240020
Seville, Andalusia, Spain
Investigational Site Number : 7240008
Bilbao, Bizkaia, Spain
Investigational Site Number : 7240010
Esplugues de Llobregat, Catalunya [Cataluña], Spain
Investigational Site Number : 7240015
Pamplona, Navarre, Spain
Investigational Site Number : 7242502
Manises, Valencia, Spain
Investigational Site Number : 7240023
Burjassot, Valenciana, Comunidad, Spain
Investigational Site Number : 7242505
Alicante, , Spain
Investigational Site Number : 7240013
Madrid, , Spain
Investigational Site Number : 7240014
Vigo, , Spain
Investigational Site Number : 7920010
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920001
Antalya, , Turkey (Türkiye)
Investigational Site Number : 7920008
Gaziantep, , Turkey (Türkiye)
Investigational Site Number : 7920003
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920006
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920009
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920004
Kayseri, , Turkey (Türkiye)
Investigational Site Number : 7920007
Samsun, , Turkey (Türkiye)
Countries
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Related Links
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EFC17561 Plain Language Results Summary
Other Identifiers
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2023-506558-20
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1275-9760
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC17561
Identifier Type: -
Identifier Source: org_study_id
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