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
NCT ID: NCT05769777
Last Updated: 2025-11-12
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
PHASE2
901 participants
INTERVENTIONAL
2023-04-03
2031-06-11
Brief Summary
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The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD.
The study duration per participant will be up to 284 weeks, including:
* A screening period of up to 2 to 4 weeks
* An open label treatment period of up to 268 weeks (approximately 5 years)
* A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264)
The planned number of visits will be 35 visits.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Amlitelimab
Subcutaneous injection as per protocol
Amlitelimab
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)
Interventions
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Amlitelimab
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)
Eligibility Criteria
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Inclusion Criteria
* Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
* Participant must have documented history (within 6 months prior to screening visit), of inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit).
* Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.
* Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2.
* AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.
* Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2.
* Able and willing to comply with requested study visits and procedures.
* Body weight must be greater than or equal to 25 kg.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.
Exclusion Criteria
* Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* 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).
* History of solid organ or stem cell transplant.
* Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed.
* Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
* Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections); and any infection which as per Investigator's opinion precludes the participant's participation in the study.
* Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
* Participants with active tuberculosis (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.
* In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology, coagulation, or urinalysis tests at the screening visit.
* In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study.
* History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
12 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Allervie Clinical Research - Birmingham- Site Number : 8400050
Birmingham, Alabama, United States
Research Solutions of Arizona- Site Number : 8400020
Litchfield Park, Arizona, United States
Medical Dermatology Specialists- Site Number : 8400016
Phoenix, Arizona, United States
Dermatology Trial Associates- Site Number : 8400027
Bryant, Arkansas, United States
University Dermatology Trials- Site Number : 8400052
Newport Beach, California, United States
Children's Hospital Colorado - Aurora- Site Number : 8400041
Aurora, Colorado, United States
IMMUNOe International Research Centers - Centennial- Site Number : 8400024
Centennial, Colorado, United States
Renaissance Research and Medical Group- Site Number : 8400006
Cape Coral, Florida, United States
Life Clinical Trials - Coral Springs- Site Number : 8400040
Coral Springs, Florida, United States
Florida Pharmaceutical Research and Associates- Site Number : 8400018
Miami, Florida, United States
Miami Clinical Research Tower- Site Number : 8400036
Miami, Florida, United States
Florida Research Center- Site Number : 8400011
Miami, Florida, United States
Bio-Medical Research- Site Number : 8400037
Miami, Florida, United States
Clinical Research Trials of Florida- Site Number : 8400054
Tampa, Florida, United States
Advanced Medical Research - Atlanta- Site Number : 8400044
Atlanta, Georgia, United States
Georgia Skin & Cancer Clinic- Site Number : 8400048
Savannah, Georgia, United States
Sneeze Wheeze & Itch Associates- Site Number : 8400002
Normal, Illinois, United States
Kentucky Advanced Medical Research- Site Number : 8400014
Murray, Kentucky, United States
Oakland Hills Dermatology- Site Number : 8400021
Auburn Hills, Michigan, United States
The Derm Institute of West Michigan- Site Number : 8400043
Caledonia, Michigan, United States
Michigan Dermatology Institute - Livonia- Site Number : 8401010
Livonia, Michigan, United States
Michigan Dermatology Institute - Waterford- Site Number : 8400010
Waterford, Michigan, United States
Forest Hills Dermatology Group @ Union Turnpike- Site Number : 8400007
Kew Gardens, New York, United States
Dermatology Research Center of Oklahoma- Site Number : 8400035
Tulsa, Oklahoma, United States
The Children's Hospital of Philadelphia- Site Number : 8400009
Philadelphia, Pennsylvania, United States
Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053
San Antonio, Texas, United States
Pioneer Research Solutions - Sugar Land- Site Number : 8400026
Sugar Land, Texas, United States
Private Practice - Dr. Marthe N. Dika- Site Number : 8400022
Burlington, Wisconsin, United States
Investigational Site Number : 0320022
General Pico, La Pampa Province, Argentina
Investigational Site Number : 0320006
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320007
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320008
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320003
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Buenos Aires, , Argentina
Investigational Site Number : 0320009
Buenos Aires, , Argentina
Investigational Site Number : 0320005
Buenos Aires, , Argentina
Investigational Site Number : 0360002
Kogarah, New South Wales, Australia
Investigational Site Number : 0360001
Sydney, New South Wales, Australia
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
Salvador, Estado de Bahia, Brazil
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022
Curitiba, Paraná, Brazil
Pontifica Universidade Catolica do Parana- 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 das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC- Site Number : 0760001
Santo André, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760003
São José do Rio Preto, São Paulo, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760006
Sorocaba, São Paulo, Brazil
IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004
Rio de Janeiro, , Brazil
Investigational Site Number : 1240001
Calgary, Alberta, Canada
Investigational Site Number : 1240052
Edmonton, Alberta, Canada
Investigational Site Number : 1240051
Vancouver, British Columbia, Canada
Investigational Site Number : 1240009
Etobicoke, Ontario, Canada
Investigational Site Number : 1240008
Mississauga, Ontario, Canada
Investigational Site Number : 1240011
Oakville, Ontario, Canada
Investigational Site Number : 1240004
Peterborough, Ontario, Canada
Investigational Site Number : 1240003
Richmond Hill, Ontario, Canada
Investigational Site Number : 1240012
Toronto, Ontario, Canada
Investigational Site Number : 1240002
Montreal, Quebec, Canada
Investigational Site Number : 1240010
Québec, Quebec, Canada
Investigational Site Number : 1240006
Québec, Quebec, Canada
Investigational Site Number : 1240044
Saskatoon, Saskatchewan, Canada
Investigational Site Number : 1520004
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520013
Lo Barnechea, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520009
Osorno, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520011
Santiago, 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 : 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 : 1520014
Chillán, , Chile
Investigational Site Number : 1560015
Beijing, , China
Investigational Site Number : 1560008
Changchun, , China
Investigational Site Number : 1560016
Changsha, , China
Investigational Site Number : 1560014
Chengdu, , China
Investigational Site Number : 1560072
Fuzhou, , China
Investigational Site Number : 1560074
Guangzhou, , China
Investigational Site Number : 1560044
Hangzhou, , China
Investigational Site Number : 1560011
Hangzhou, , China
Investigational Site Number : 1560013
Jingzhou, , China
Investigational Site Number : 1560001
Shanghai, , China
Investigational Site Number : 1560018
Suzhou, , China
Investigational Site Number : 1560010
Taiyuan, , China
Investigational Site Number : 1560073
Taizhou, , China
Investigational Site Number : 1560019
Xinxiang, , China
Investigational Site Number : 1560012
Yinchuan, , China
Investigational Site Number : 1560028
Zhenjiang, , China
Investigational Site Number : 2032105
Nový Jičín, , Czechia
Investigational Site Number : 2032104
Ostrava, , Czechia
Investigational Site Number : 2032102
Prague, , Czechia
Investigational Site Number : 2030003
Prague, , Czechia
Investigational Site Number : 2030006
Prague, , Czechia
Investigational Site Number : 2030007
Prague, , Czechia
Investigational Site Number : 2080001
Aarhus, , Denmark
Investigational Site Number : 2500004
Créteil, , France
Investigational Site Number : 2500001
Lille, , France
Investigational Site Number : 2500005
Marseille, , France
Investigational Site Number : 2500009
Nantes, , France
Investigational Site Number : 2500003
Paris, , France
Investigational Site Number : 2500006
Pierre-Bénite, , France
Investigational Site Number : 2500002
Toulouse, , France
Investigational Site Number : 2760009
Bad Bentheim, , Germany
Investigational Site Number : 2762203
Berlin, , Germany
Investigational Site Number : 2762205
Dresden, , Germany
Investigational Site Number : 2762201
Münster, , Germany
Investigational Site Number : 2760010
Osnabrück, , Germany
Investigational Site Number : 3560006
Bengaluru, , India
Investigational Site Number : 3560007
Bikaner, , India
Investigational Site Number : 3560003
Gurugram, , India
Investigational Site Number : 3560011
Kochi, , India
Investigational Site Number : 3560005
Kolkata, , India
Investigational Site Number : 3560004
Mangaluru, , India
Investigational Site Number : 3560002
Nashik, , India
Investigational Site Number : 3560008
Surat, , India
Investigational Site Number : 3800003
Milan, Milano, Italy
Investigational Site Number : 3800002
Naples, Napoli, Italy
Investigational Site Number : 3800004
Naples, Napoli, Italy
Investigational Site Number : 3800007
Rome, Roma, Italy
Investigational Site Number : 3800006
Rome, Roma, Italy
Investigational Site Number : 3800005
Brescia, , Italy
Investigational Site Number : 3800008
Vicenza, , Italy
Investigational Site Number : 3923114
Obihiro, Hokkaido, Japan
Investigational Site Number : 3923113
Yokohama, Kanagawa, 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 : 4840001
Chihuahua City, , Mexico
Investigational Site Number : 4840008
Durango, , Mexico
Investigational Site Number : 5280002
Breda, , Netherlands
Investigational Site Number : 5280004
Rotterdam, , Netherlands
Investigational Site Number : 5280001
Utrecht, , Netherlands
Investigational Site Number : 6160014
Lodz, Lódzkie, Poland
Investigational Site Number : 6162411
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160009
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160007
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160006
Gdansk, Pomeranian Voivodeship, Poland
Investigational Site Number : 6160001
Chorzów, Silesian Voivodeship, Poland
Investigational Site Number : 6160003
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160012
Lublin, , Poland
Caribbean Medical Research Center- Site Number : 8400028
San Juan, , Puerto Rico
Investigational Site Number : 7100011
Cape Town, , South Africa
Investigational Site Number : 7100010
Cape Town, , South Africa
Investigational Site Number : 7100002
Cape Town, , South Africa
Investigational Site Number : 7100009
Cape Town, , South Africa
Investigational Site Number : 7100012
Durban, , South Africa
Investigational Site Number : 7100015
Durban, , South Africa
Investigational Site Number : 7100007
Johannesburg, , South Africa
Investigational Site Number : 7100006
Kempton Park, , South Africa
Investigational Site Number : 7100005
Middelburg, , South Africa
Investigational Site Number : 7100003
Pretoria, , South Africa
Investigational Site Number : 7100014
Pretoria, , South Africa
Investigational Site Number : 7100004
Reiger Park, , South Africa
Investigational Site Number : 4100002
Ansan-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100016
Bucheon-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100003
Yangsan, Gyeongsangnam-do, South Korea
Investigational Site Number : 4100018
Incheon, Incheon-gwangyeoksi, South Korea
Investigational Site Number : 4100006
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 : 7240022
Sabadell, Barcelona [Barcelona], Spain
Investigational Site Number : 7242505
Alicante, , Spain
Investigational Site Number : 7242501
Córdoba, , Spain
Investigational Site Number : 7240021
Madrid, , Spain
Investigational Site Number : 7242503
Madrid, , Spain
Investigational Site Number : 7240006
Valencia, , Spain
Investigational Site Number : 7560002
Buochs, , Switzerland
Investigational Site Number : 1580006
Hsinchu, , Taiwan
Investigational Site Number : 1583201
Kaohsiung City, , Taiwan
Investigational Site Number : 1580002
New Taipei City, , Taiwan
Investigational Site Number : 1583202
Taichung, , Taiwan
Investigational Site Number : 1580007
Taichung, , Taiwan
Investigational Site Number : 1580001
Taipei, , Taiwan
Investigational Site Number : 1583203
Taoyuan, , Taiwan
Investigational Site Number : 7920002
Aydin, , Turkey (Türkiye)
Investigational Site Number : 7920003
İzmit, , Turkey (Türkiye)
Investigational Site Number : 7920005
Manisa, , Turkey (Türkiye)
Investigational Site Number : 7920004
Trabzon, , Turkey (Türkiye)
Investigational Site Number : 8260001
London, England, United Kingdom
Investigational Site Number : 8262601
London, London, City of, United Kingdom
Investigational Site Number : 8260002
Edinburgh, , United Kingdom
Investigational Site Number : 8260004
Sheffield, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free number for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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LTS17789 Plain Language Results Summary
Other Identifiers
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U1111-1280-6080
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502188-39
Identifier Type: REGISTRY
Identifier Source: secondary_id
LTS17789
Identifier Type: -
Identifier Source: org_study_id