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)
NCT ID: NCT06181435
Last Updated: 2025-12-10
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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ACTIVE_NOT_RECRUITING
PHASE3
589 participants
INTERVENTIONAL
2023-12-21
2026-03-18
Brief Summary
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The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older.
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
Amlitelimab dose 2
Subcutaneous injection as per protocol
Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
Placebo
Subcutaneous injection as per protocol
Placebo
Pharmaceutical form:
Injection solution Route of administration: SC injection
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
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 either inadequate response or inadvisability 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 patient's 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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Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, Arizona, United States
Eclipse Clinical Research- Site Number : 8401158
Tucson, Arizona, United States
Torrance Clinical Research- Site Number : 8401027
Lomita, California, United States
Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, California, United States
Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079
Mission Viejo, California, United States
Cura Clinical Research - Oxnard- Site Number : 8401142
Oxnard, California, United States
Clinical Science Institute- Site Number : 8401028
Santa Monica, California, United States
University of Connecticut Health Center- Site Number : 8401115
Farmington, Connecticut, United States
Pediatric Skin Research- Site Number : 8401198
Coral Gables, Florida, United States
Skin Care Research - Hollywood- Site Number : 8401071
Hollywood, Florida, United States
Savin Medical Group - Miami- Site Number : 8401085
Miami, Florida, United States
Anchor Medical Research- Site Number : 8401300
Miami, Florida, United States
Accel Research - Nona Pediatric Center- Site Number : 8401081
Orlando, Florida, United States
Nuline Clinical Trial Center- Site Number : 8401161
Pompano Beach, Florida, United States
Clinical Research Trials of Florida- Site Number : 8401023
Tampa, Florida, United States
AllerVie Clinical Research - Columbus- Site Number : 8401104
Columbus, Georgia, United States
First Georgia Physician Group- Site Number : 8401190
Fayetteville, Georgia, United States
Access Dermatology- Site Number : 8401296
Bowling Green, Kentucky, United States
MedPharmics - Covington- Site Number : 8401137
Covington, Louisiana, United States
Care Access Research - Marriottsville- Site Number : 8401126
Marriottsville, Maryland, United States
Tufts Medical Center Site Number : 8401201
Boston, Massachusetts, United States
University Of Mississippi Medical Center- Site Number : 8401184
Jackson, Mississippi, United States
Care Access - Hoboken- Site Number : 8401132
Hoboken, New Jersey, United States
University of New Mexico Comprehensive Cancer Center- Site Number : 8401263
Albuquerque, New Mexico, United States
OmeraNY- Site Number : 8401156
Brooklyn, New York, United States
Equity Medical- Site Number : 8401239
New York, New York, United States
Montefiore Medical Center - Moses Campus- Site Number : 8401150
The Bronx, New York, United States
Red River Research Partners- Site Number : 8401196
Fargo, North Dakota, United States
Bexley Dermatology Research- Site Number : 8401051
Bexley, Ohio, United States
Velocity Clinical Research - Springdale- Site Number : 8401153
Cincinnati, Ohio, United States
Dermatology Associates of Plymouth Meeting- Site Number : 8401147
Plymouth Meeting, Pennsylvania, United States
PEAK Research- Site Number : 8401083
Upper Saint Clair, Pennsylvania, United States
Columbia Dermatology & Aesthetics- Site Number : 8401166
Columbia, South Carolina, United States
Health Concepts- Site Number : 8401059
Rapid City, South Dakota, United States
Arlington Research Center- Site Number : 8401248
Arlington, Texas, United States
Derm Texas- Site Number : 8401217
Dallas, Texas, United States
Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063
Houston, Texas, United States
Prolato Clinical Research Center- Site Number : 8401209
Houston, Texas, United States
Sienna Dermatology- Site Number : 8401148
Missouri City, Texas, United States
Progressive Clinical Research - San Antonio- Site Number : 8401016
San Antonio, Texas, United States
Advanced Research Institute - Odgen- Site Number : 8401057
Ogden, Utah, United States
Care Access - Arlington- Site Number : 8401134
Arlington, Virginia, United States
Velocity Clinical Research - Hampton- Site Number : 8401154
Hampton, Virginia, United States
Investigational Site Number : 0320021
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320017
Pilar, Buenos Aires, Argentina
Investigational Site Number : 0320006
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320007
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320015
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320016
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320009
Buenos Aires, , Argentina
Investigational Site Number : 1002008
Gabrovo, , Bulgaria
Investigational Site Number : 1002004
Pleven, , Bulgaria
Investigational Site Number : 1002005
Sofia, , Bulgaria
Investigational Site Number : 1520004
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520013
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520014
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520015
Quillota, Región de Valparaíso, Chile
Investigational Site Number : 1560004
Beijing, , China
Investigational Site Number : 1560030
Beijing, , China
Investigational Site Number : 1560022
Chengdu, , China
Investigational Site Number : 1560021
Guangzhou, , China
Investigational Site Number : 1560025
Guangzhou, , China
Investigational Site Number : 1560002
Hangzhou, , China
Investigational Site Number : 1560006
Hangzhou, , China
Investigational Site Number : 1560029
Hangzhou, , China
Investigational Site Number : 1560007
Jinan, , China
Investigational Site Number : 1560024
Ningbo, , China
Investigational Site Number : 1560001
Shanghai, , China
Investigational Site Number : 1560005
Shanghai, , China
Investigational Site Number : 1560026
Shenyang, , China
Investigational Site Number : 1560023
Wenzhou, , China
Investigational Site Number : 1560003
Wuxi, , China
Investigational Site Number : 1560028
Zhenjiang, , China
Investigational Site Number : 2032106
Kutná Hora, , Czechia
Investigational Site Number : 2030010
Olomouc, , Czechia
Investigational Site Number : 2032104
Ostrava, , Czechia
Investigational Site Number : 2030011
Prague, , Czechia
Investigational Site Number : 2030006
Prague, , Czechia
Investigational Site Number : 2080002
Aalborg, , Denmark
Investigational Site Number : 2080001
Aarhus, , Denmark
Investigational Site Number : 2080003
Herlev, , Denmark
Investigational Site Number : 3800018
Rozzano, Milano, Italy
Investigational Site Number : 3800013
Rome, Roma, Italy
Investigational Site Number : 3800009
Catania, , Italy
Investigational Site Number : 3800008
Pisa, , Italy
Investigational Site Number : 3800022
Vicenza, , 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 : 3923109
Habikino, Osaka, 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 : 3923108
Kagoshima, , Japan
Investigational Site Number : 3923102
Kyoto, , Japan
Investigational Site Number : 3920003
Kyoto, , Japan
Investigational Site Number : 4840011
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840005
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840012
Aguascalientes, , Mexico
Investigational Site Number : 4840009
Durango, , Mexico
Investigational Site Number : 4840003
Veracruz, , Mexico
Investigational Site Number : 6200005
Lisbon, , Portugal
Investigational Site Number : 6200004
Lisbon, , Portugal
Investigational Site Number : 6200001
Lisbon, , Portugal
Investigational Site Number : 6200003
Porto, , Portugal
Investigational Site Number : 7100004
Boksburg, , South Africa
Investigational Site Number : 7100010
Cape Town, , South Africa
Investigational Site Number : 7100009
Cape Town, , South Africa
Investigational Site Number : 7100012
Durban, , South Africa
Investigational Site Number : 7100001
Durban, , South Africa
Investigational Site Number : 7100015
Johannesburg, , South Africa
Investigational Site Number : 7100007
Johannesburg, , South Africa
Investigational Site Number : 7100003
Pretoria, , South Africa
Investigational Site Number : 7240012
Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number : 7240018
Granada, , Spain
Investigational Site Number : 7240029
Madrid, , Spain
Investigational Site Number : 7242503
Madrid, , Spain
Investigational Site Number : 7520006
Älvsjö, , Sweden
Investigational Site Number : 7520001
Örebro, , Sweden
Investigational Site Number : 7920001
Antalya, , 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 : 7920004
Kayseri, , Turkey (Türkiye)
Investigational Site Number : 7920011
Mersin, , Turkey (Türkiye)
Investigational Site Number : 7920007
Samsun, , Turkey (Türkiye)
Investigational Site Number : 8260003
Portsmouth, Hampshire, United Kingdom
Investigational Site Number : 8262602
London, London, City of, United Kingdom
Investigational Site Number : 8262601
London, London, City of, United Kingdom
Investigational Site Number : 8260006
Glasgow, , United Kingdom
Investigational Site Number : 8260004
Leicester, , United Kingdom
Countries
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Related Links
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EFC17560 Plain Language Results Summary
Other Identifiers
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2023-506557-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1275-9665
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC17560
Identifier Type: -
Identifier Source: org_study_id
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