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
Launched by SANOFI · Mar 3, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment called amlitelimab for people aged 12 and older who have moderate to severe atopic dermatitis, also known as eczema. The goal is to see how safe and effective this treatment is over a long period. Participants will be involved in the study for up to 180 weeks, which includes a screening period, a treatment phase lasting about three years, and a follow-up period after treatment ends.
To join the study, participants need to have had eczema for at least a year and have not responded well to other topical treatments. They should also have a certain level of severity in their condition, which can be measured using specific scales. Throughout the study, participants will visit the research site 26 times to monitor their health and response to the treatment. It's important to know that there are some specific criteria that might exclude someone from participating, such as having certain infections or medical conditions. Overall, this trial aims to provide valuable information about a new option for managing atopic dermatitis.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participant must be at least 12 years of age inclusive, at the time of signing the informed consent.
- • 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.
- • 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:
- • Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator's judgement
- • 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.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Taipei, , Taiwan
Caba, Buenos Aires, Argentina
Santiago, Reg Metropolitana De Santiago, Chile
Ciudad Autonoma Buenos Aires, , Argentina
Calgary, Alberta, Canada
Tachikawa Shi, Tokyo, Japan
Seoul, , Korea, Republic Of
Obihiro Shi, Hokkaido, Japan
Sakai Shi, Osaka, Japan
Yokohama Shi, Kanagawa, Japan
Shimotsuga Gun, Tochigi, Japan
Oakville, Ontario, Canada
Peterborough, Ontario, Canada
Etobicoke, Ontario, Canada
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Quebec, , Canada
Quebec, , Canada
Richmond Hill, , Canada
Valdivia, Los Ríos, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Daejeon, , Korea, Republic Of
Salvador, Bahia, Brazil
Santo Andre, São Paulo, Brazil
Osorno, Los Lagos, Chile
Daejeon, Daejeon Gwangyeoksi, Korea, Republic Of
Ansan Si, Gyeonggi Do, Korea, Republic Of
Yangsan Si, Gyeongsangnam Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Cape Town, , South Africa
Claremont, , South Africa
Durban, , South Africa
Kempton Park, , South Africa
Reiger Park, , South Africa
Sandton, , South Africa
Napoli, , Italy
London, London, City Of, United Kingdom
Caba, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Brescia, , Italy
Cape Town, , South Africa
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Napoli, , Italy
Paris, , France
Chihuahua, , Mexico
Santiago, Reg Metropolitana De Santiago, Chile
Roma, , Italy
Buenos Aires, , Argentina
Sao Jose Do Rio Preto, São Paulo, Brazil
Ostrava, , Czechia
Praha 10, , Czechia
Berlin, , Germany
Münster, , Germany
Obihiro Shi, Hokkaido, Japan
Yokohama Shi, Kanagawa, Japan
Sakai Shi, Osaka, Japan
Shimotsuga Gun, Tochigi, Japan
Madrid, Madrid, Comunidad De, Spain
Alicante, , Spain
Córdoba, , Spain
Taichung, , Taiwan
London, London, City Of, United Kingdom
Shanghai, , China
Breda, , Netherlands
Ciudad Autonoma Buenos Aires, , Argentina
Aarhus, , Denmark
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Caba, Ciudad De Buenos Aires, Argentina
Caba, Ciudad De Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Salvador, Bahia, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Ribeirao Preto, São Paulo, Brazil
Santo Andre, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Rio De Janeiro, , Brazil
Calgary, Alberta, Canada
Etobicoke, Ontario, Canada
Mississauga, Ontario, Canada
Oakville, Ontario, Canada
Peterborough, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Quebec, , Canada
Quebec, , Canada
Richmond Hill, , Canada
Osorno, Los Lagos, Chile
Valdivia, Los Ríos, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Novy Jicin, , Czechia
Praha 10, , Czechia
Praha 6, , Czechia
Lille, , France
Toulouse, , France
Bad Bentheim, , Germany
Osnabrück, , Germany
Milano, Lombardia, Italy
Roma, , Italy
Tachikawa Shi, Tokyo, Japan
Daejeon, Daejeon Gwangyeoksi, Korea, Republic Of
Ansan Si, Gyeonggi Do, Korea, Republic Of
Yangsan Si, Gyeongsangnam Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Rotterdam, , Netherlands
Utrecht, , Netherlands
Cape Town, , South Africa
Cape Town, , South Africa
Claremont, , South Africa
Durban, , South Africa
Johannesburg, , South Africa
Kempton Park, , South Africa
Middelburg, , South Africa
Pretoria, , South Africa
Reiger Park, , South Africa
Sandton, , South Africa
Badalona, Catalunya [Cataluña], Spain
Valencia, , Spain
Kaohsiung 833, , Taiwan
New Taipei City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Caba, Buenos Aires, Argentina
Pierre Benite, , France
Ribeirao Preto, São Paulo, Brazil
Creteil, , France
Marseille, , France
Gdansk, Pomorskie, Poland
Katowice, Slaskie, Poland
Chorzow, , Poland
Warszawa, , Poland
Warszawa, , Poland
Pretoria, , South Africa
Taoyuan County, , Taiwan
Edinburgh, , United Kingdom
Kogarah, New South Wales, Australia
Praha 8, , Czechia
Jingzhou, , China
Nashik, , India
Chengdu, , China
Bikaner, , India
Surat, , India
Benito Juarez, Ciudad De Mexico, Mexico
Taiyuan, , China
Mangalore, , India
Zhenjiang, , China
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Caba, Ciudad De Buenos Aires, Argentina
Changchun, , China
Yinchuan, , China
Yiwu, , China
Hangzhou, , China
Nantes, , France
Bucheon Si, Gyeonggi Do, Korea, Republic Of
Changsha, , China
Suzhou, , China
Miami, Florida, United States
Curitiba, Paraná, Brazil
Saskatoon, Saskatchewan, Canada
Xinxiang, , China
Gurgaon, , India
Kolkata, , India
Sheffield, , United Kingdom
Yokohama Shi, , Japan
Rome, Roma, Italy
Incheon, , Korea, Republic Of
Porto Alegre, Rio Grande Do Sul, Brazil
Sorocaba, São Paulo, Brazil
Santo André, , Brazil
Yangsan Si, Gyeongsangnam Do, Korea, Republic Of
Warsaw, , Poland
Warsaw, , Poland
Kaohsiung City, , Taiwan
Taipei City, , Taiwan
Santo André, São Paulo, Brazil
Sakai, Osaka, Japan
Mibu, Tochigi, Japan
Tachikawa, Tokyo, Japan
Yokohama, , Japan
Rotterdam, , Netherlands
Warsaw, Mazowieckie, Poland
Naples, Napoli, Italy
Buenos Aires, , Argentina
Salvador, Bahia, Brazil
Mississauga, Ontario, Canada
Peterborough, Ontario, Canada
Québec City, Quebec, Canada
Nový Jičín, , Czechia
Pierre Bénite, , France
Milan, Lombardia, Italy
Obihiro, Hokkaido, Japan
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Bryant, Arkansas, United States
Miami, Florida, United States
Miami, Florida, United States
Auburn Hills, Michigan, United States
Caledonia, Michigan, United States
Livonia, Michigan, United States
Troy, Michigan, United States
Waterford, Michigan, United States
Kew Gardens, New York, United States
Woodbury, New York, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Buenos Aires, Ciudad De Buenos Aires, Argentina
Gral. Pico, La Pampa, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Sydney, New South Wales, Australia
Curitiba, Paraná, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Ribeirão Preto, São Paulo, Brazil
Sao Jose Do Rio Preto, São Paulo, Brazil
Rio De Janeiro, , Brazil
Québec City, Quebec, Canada
Richmond Hill, , Canada
Santiago, Reg Metropolitana De Santiago, Chile
Hangzhou, , China
Zhenjiang, , China
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Créteil, , France
Marseille, , France
Mangaluru, , India
Rome, Roma, Italy
Incheon, , Korea, Republic Of
Chorzow, , Poland
Boksburg, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Johannesburg, , South Africa
Johannesburg, , South Africa
Hsinchu, , Taiwan
New Taipei City, , Taiwan
Taoyuan City, , Taiwan
Edinburgh, , United Kingdom
Coral Springs, Florida, United States
Miami, Florida, United States
Guangzhou, , China
Gurugram, , India
Phoenix, Arizona, United States
Centennial, Colorado, United States
Cape Coral, Florida, United States
Miami, Florida, United States
Sioux City, Iowa, United States
Baton Rouge, Louisiana, United States
Oklahoma City, Oklahoma, United States
Sugar Land, Texas, United States
São José Do Rio Preto, São Paulo, Brazil
Montreal, Quebec, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Fuzhou, , China
Naples, , Italy
San Juan, , Puerto Rico
Pretoria, , South Africa
Taichung, , Taiwan
Baton Rouge, Louisiana, United States
Taichung, , Taiwan
Birmingham, Alabama, United States
Litchfield Park, Arizona, United States
Centennial, Colorado, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Murray, Kentucky, United States
Baton Rouge, Louisiana, United States
Warren, Michigan, United States
Oklahoma City, Oklahoma, United States
Burlington, Wisconsin, United States
Edmonton, Alberta, Canada
Osorno, Los Lagos, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Beijing, , China
Taizhou, , China
Lochner Road, , South Africa
Newport Beach, California, United States
Miami, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Normal, Illinois, United States
Murray, Kentucky, United States
Buenos Aires, , Argentina
Birmingham, Alabama, United States
Aurora, Colorado, United States
Coral Springs, Florida, United States
Miami, Florida, United States
Kew Gardens, New York, United States
Philadelphia, Pennsylvania, United States
Burlington, Wisconsin, United States
General Pico, La Pampa, Argentina
Buenos Aires, , Argentina
Richmond Hill, Ontario, Canada
Chillán, , Chile
Guangzhou, , China
Milan, Milano, Italy
Naples, Napoli, Italy
Yokohama, Kanagawa, Japan
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Durango, , Mexico
Warsaw, Mazowieckie, Poland
Warsaw, Mazowieckie, Poland
Chorzow, Slaskie, Poland
Caguas, , Puerto Rico
Durban, , South Africa
Badalona, Barcelona [Barcelona], Spain
Madrid, , Spain
Buochs, , Switzerland
London, England, United Kingdom
Tulsa, Oklahoma, United States
San Antonio, Texas, United States
São José Do Rio Preto, São Paulo, Brazil
Vancouver, British Columbia, Canada
Bangalore, , India
Caserta, , Italy
Lodz, Lódzkie, Poland
Lublin, , Poland
San Juan, , Puerto Rico
Sabadell, Castilla Y León, Spain
Manisa, , Turkey
Vicenza, , Italy
Madrid, , Spain
Aydin, , Turkey
Izmit, , Turkey
Trabzon, , Turkey
London, , United Kingdom
Curitiba, , Brazil
Curitiba, , Brazil
Ribeirão Preto, , Brazil
Sorocaba, , Brazil
São José Do Rio Preto, , Brazil
Valdivia, , Chile
Incheon, Incheon Gwangyeoksi, Korea, Republic Of
Lodz, , Poland
Badalona, , Spain
Sabadell, , Spain
Sandy Springs, Georgia, United States
Livonia, Michigan, United States
Waterford, Michigan, United States
Woodbury, New York, United States
Sugar Land, Texas, United States
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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