A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
NCT ID: NCT06241118
Last Updated: 2026-01-08
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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RECRUITING
PHASE3
390 participants
INTERVENTIONAL
2024-02-29
2026-09-14
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 have had an inadequate response to prior biologic or an oral JAKi therapy.
Study details include:
At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).
The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.
The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period.
The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).
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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: Subcutaneous
Topical corticosteroids
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Topical tacrolimus or pimecrolimus
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Amlitelimab dose 2
Subcutaneous injection as per protocol
Amlitelimab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Topical corticosteroids
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Topical tacrolimus or pimecrolimus
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Placebo
Subcutaneous injection as per protocol
Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Topical corticosteroids
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Topical tacrolimus or pimecrolimus
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Interventions
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Amlitelimab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Topical corticosteroids
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Topical tacrolimus or pimecrolimus
Pharmaceutical form: Various 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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
* 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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University of Alabama at Birmingham- Site Number : 8401267
Birmingham, Alabama, United States
Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, Arizona, United States
Arkansas Dermatology- Site Number : 8401244
Little Rock, Arkansas, United States
Encino Research Center- Site Number : 8401042
Encino, California, United States
Center for Dermatology Clinical Research- Site Number : 8401018
Fremont, California, United States
Long Beach Clinical Trials- Site Number : 8401188
Long Beach, California, United States
Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, California, United States
LA Universal Research Center- Site Number : 8401064
Los Angeles, California, United States
University Dermatology Trials- Site Number : 8401339
Newport Beach, California, United States
Rady Children's Hospital- Site Number : 8401291
San Diego, California, United States
Therapeutics Clinical Research- Site Number : 8401283
San Diego, California, United States
Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245
Wheat Ridge, Colorado, United States
Encore Medical Research of Boynton Beach- Site Number : 8401030
Boynton Beach, Florida, United States
St. Jude Clinical Research- Site Number : 8401287
Doral, Florida, United States
Apex Clinical Research - Jacksonville- Site Number : 8401332
Jacksonville, Florida, United States
Global Clinical Professionals (GCP)- Site Number : 8401045
St. Petersburg, Florida, United States
Avita Clinical Research- Site Number : 8401073
Tampa, Florida, United States
Northwestern University- Site Number : 8401285
Chicago, Illinois, United States
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038
Skokie, Illinois, United States
Dawes Fretzin Clinical Research- Site Number : 8401015
Indianapolis, Indiana, United States
Equity Medical - Bowling Green- Site Number : 8401296
Bowling Green, Kentucky, United States
Tandem Clinical Research - Metairie- Site Number : 8401187
Metairie, Louisiana, United States
University of Michigan Health System - Ann Arbor- Site Number : 8401290
Ann Arbor, Michigan, United States
MI Skin Center- Site Number : 8401307
Northville, Michigan, United States
Skin Specialists- Site Number : 8401068
Omaha, Nebraska, United States
Schweiger Dermatology Group - East Windsor- Site Number : 8401338
East Windsor, New Jersey, United States
The University of New Mexico- Site Number : 8401263
Albuquerque, New Mexico, United States
Equity Medical- Site Number : 8401239
New York, New York, United States
Sadick Research Group - New York - Park Avenue- Site Number : 8401050
New York, New York, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8401279
Cincinnati, Ohio, United States
Oregon Health & Science University (OHSU)- Site Number : 8401247
Portland, Oregon, United States
Paddington Testing Company- Site Number : 8401041
Philadelphia, Pennsylvania, United States
Clinical Research of Philadelphia- Site Number : 8401193
Philadelphia, Pennsylvania, United States
Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282
Charleston, South Carolina, United States
Arlington Research Center- Site Number : 8401248
Arlington, Texas, United States
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288
Bellaire, Texas, United States
Reveal Research Institute - Dallas- Site Number : 8401219
Dallas, Texas, United States
Advanced Research Institute - Odgen- Site Number : 8401057
Ogden, Utah, United States
Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
Norfolk, Virginia, United States
North Sound Dermatology- Site Number : 8401280
Mill Creek, Washington, United States
Children's Wisconsin- Site Number : 8401246
Milwaukee, Wisconsin, United States
Cheyenne Skin Clinic- Site Number : 8401234
Cheyenne, Wyoming, United States
Investigational Site Number : 0320007
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320011
Buenos Aires, , Argentina
Investigational Site Number : 0320019
Buenos Aires, , Argentina
Investigational Site Number : 0320014
Córdoba, , Argentina
Investigational Site Number : 0360008
Melbourne, Victoria, Australia
Investigational Site Number : 0360006
Melbourne, Victoria, Australia
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
Salvador, Estado de Bahia, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, Brazil
Faculdade de Medicina do ABC- Site Number : 0760001
Santo André, São Paulo, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760006
Sorocaba, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
São Paulo, , Brazil
Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
São Paulo, , Brazil
Investigational Site Number : 1240019
Calgary, Alberta, Canada
Investigational Site Number : 1240016
Edmonton, Alberta, Canada
Investigational Site Number : 1240058
Burlington, Ontario, Canada
Investigational Site Number : 1240020
Hamilton, Ontario, Canada
Investigational Site Number : 1240053
London, Ontario, Canada
Investigational Site Number : 1240054
Toronto, Ontario, Canada
Investigational Site Number : 1240028
Regina, Saskatchewan, Canada
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520010
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 : 1560031
Changchun, , China
Investigational Site Number : 1560021
Guangzhou, , China
Investigational Site Number : 1560036
Guangzhou, , China
Investigational Site Number : 1560044
Hangzhou, , China
Investigational Site Number : 1560002
Hangzhou, , China
Investigational Site Number : 1560009
Hangzhou, , China
Investigational Site Number : 1560034
Nanyang, , China
Investigational Site Number : 1560024
Ningbo, , China
Investigational Site Number : 1560035
Ningbo, , China
Investigational Site Number : 1560001
Shanghai, , China
Investigational Site Number : 1560041
Shenyang, , China
Investigational Site Number : 1560038
Wuhan, , China
Investigational Site Number : 1560032
Xi'an, , China
Investigational Site Number : 2500011
Bordeaux, , France
Investigational Site Number : 2500014
Clermont-Ferrand, , France
Investigational Site Number : 2500004
Créteil, , France
Investigational Site Number : 2500001
Lille, , France
Investigational Site Number : 2500017
Paris, , France
Investigational Site Number : 2500012
Rouen, , France
Investigational Site Number : 2762203
Berlin, , Germany
Investigational Site Number : 2762202
Blankenfelde-Mahlow, , Germany
Investigational Site Number : 2761001
Dresden, , Germany
Investigational Site Number : 2760022
Frankfurt, , Germany
Investigational Site Number : 2761002
Lübeck, , Germany
Investigational Site Number : 2760019
Witten, , Germany
Investigational Site Number : 3000004
Athens, , Greece
Investigational Site Number : 3000001
Athens, , Greece
Investigational Site Number : 3000005
Athens, , Greece
Investigational Site Number : 3000002
Thessaloniki, , Greece
Investigational Site Number : 3760005
Beersheba, , Israel
Investigational Site Number : 3760008
Ramat Gan, , Israel
Investigational Site Number : 3760007
Tel Aviv, , Israel
Investigational Site Number : 3800017
Naples, Napoli, Italy
Investigational Site Number : 3800020
Turin, Torino, Italy
Investigational Site Number : 3800016
Chieti, , Italy
Investigational Site Number : 3800021
Modena, , Italy
Investigational Site Number : 3800015
Perugia, , Italy
Investigational Site Number : 3923113
Yokohama, Kanagawa, Japan
Investigational Site Number : 3923109
Habikino, Osaka, Japan
Investigational Site Number : 3923110
Sakai, Osaka, Japan
Investigational Site Number : 3923106
Mibu, Tochigi, Japan
Investigational Site Number : 3920001
Tachikawa, Tokyo, Japan
Investigational Site Number : 3920007
Hiroshima, , Japan
Investigational Site Number : 4840011
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840003
Veracruz, , Mexico
Investigational Site Number : 5280001
Utrecht, , Netherlands
Investigational Site Number : 6162417
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160002
Lublin, Lublin Voivodeship, Poland
Investigational Site Number : 6162411
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160006
Gdansk, Pomeranian Voivodeship, Poland
Investigational Site Number : 2500016
Saint-Pierre, , Reunion
Investigational Site Number : 6820001
Riyadh, , Saudi Arabia
Investigational Site Number : 4100002
Ansan-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100014
Seongnam-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100015
Bupyeong-gu, Incheon-gwangyeoksi, South Korea
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240002
Badalona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240017
Majadahonda, Madrid, Spain
Investigational Site Number : 7240016
Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number : 7240020
Seville, Sevilla, Spain
Investigational Site Number : 7242505
Alicante, , Spain
Investigational Site Number : 7242503
Madrid, , Spain
Investigational Site Number : 1583201
Kaohsiung City, , Taiwan
Investigational Site Number : 1580001
Taipei, , Taiwan
Investigational Site Number : 1580003
Taipei, , Taiwan
Investigational Site Number : 1583203
Taoyuan, , Taiwan
Investigational Site Number : 7920008
Gaziantep, , Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7841002
Abu Dhabi, , United Arab Emirates
Investigational Site Number : 7840001
Abu Dhabi, , United Arab Emirates
Investigational Site Number : 7840002
Abu Dhabi, , United Arab Emirates
Investigational Site Number : 8260013
Bristol, Bristol, City of, United Kingdom
Investigational Site Number : 8260012
Plymouth, Devon, United Kingdom
Investigational Site Number : 8262603
London, England, United Kingdom
Investigational Site Number : 8260015
London, England, United Kingdom
Investigational Site Number : 8260003
Portsmouth, Hampshire, United Kingdom
Investigational Site Number : 8260009
Leeds, North Yorkshire, United Kingdom
Investigational Site Number : 8260010
Nottingham, Nottinghamshire, United Kingdom
Investigational Site Number : 8260008
Liverpool, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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EFC17599 Plain Language Results Summary
Other Identifiers
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2023-508099-12
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1295-3059
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC17599
Identifier Type: -
Identifier Source: org_study_id
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