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
Launched by SANOFI · Jan 16, 2024
Trial Information
Current as of July 31, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying 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 effective and safe this treatment is compared to a placebo, which is a dummy treatment that looks the same but has no active ingredients. Participants must have had some trouble getting relief from their current topical treatments, like corticosteroids, and have been diagnosed with atopic dermatitis for at least a year. Key eligibility criteria include having a certain level of skin involvement and symptoms that still cause discomfort despite treatment.
If you join this study, you can expect to participate for up to 44 weeks, which includes time for screening, treatment, and follow-up visits. During the study, you will have up to 10 visits to the clinic. After the initial treatment period, there may be an option to continue in a separate study. This trial is currently recruiting participants, and it's important to note that some individuals with certain health conditions or recent treatments may not be eligible to join.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants must be 12 years of age (when signing informed consent form)
- • 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:
- Participants are excluded from the study if any of the following criteria apply:
- • 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
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
Istanbul, , Turkey
Chuo Ku, Tokyo, Japan
Santiago, Reg Metropolitana De Santiago, Chile
Esplugues De Llobregat, Catalunya [Cataluña], Spain
Pleven, , Bulgaria
Markham, Ontario, Canada
Waterloo, Ontario, Canada
Ostrava, , Czechia
Kiel, , Germany
Münster, , Germany
Obihiro Shi, Hokkaido, Japan
Kagoshima Shi, Kagoshima, Japan
Yokohama Shi, Kanagawa, Japan
Sakai Shi, Osaka, Japan
Shimotsuga Gun, Tochigi, Japan
Minato Ku, Tokyo, Japan
Habikino Shi, , Japan
Kyoto Shi, , Japan
Alicante, , Spain
Istanbul, , Turkey
Samsun, , Turkey
Caba, Ciudad De Buenos Aires, Argentina
Buenos Aires, , Argentina
Salvador, Bahia, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Peterborough, Ontario, Canada
Toronto, Ontario, Canada
Quebec, , Canada
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
Toulouse, , France
Bad Bentheim, , Germany
Milano, Lombardia, Italy
Tachikawa Shi, Tokyo, Japan
Tampa, Florida, United States
Pierre Benite, , France
San Antonio, Texas, United States
Sugarloaf, Pennsylvania, United States
San Antonio, Texas, United States
Hollywood, Florida, United States
Missouri City, Texas, United States
Kyoto Shi, Kyoto, Japan
Habikino Shi, , Japan
Birmingham, Alabama, United States
Fort Smith, Arkansas, United States
Encino, California, United States
Huntington Beach, California, United States
Los Angeles, California, United States
Saint Petersburg, Florida, United States
Dawsonville, Georgia, United States
Indianapolis, Indiana, United States
Ypsilanti, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Portsmouth, New Hampshire, United States
Tulsa, Oklahoma, United States
Sugar Land, Texas, United States
Ciudad Autonoma Buenos Aires, , Argentina
Winnipeg, Manitoba, Canada
Richmond Hill, Ontario, Canada
Palmdale, California, United States
Miami, Florida, United States
Skokie, Illinois, United States
Charleston, South Carolina, United States
Sugar Land, Texas, United States
Bountiful, Utah, United States
Osorno, Reg Metropolitana De Santiago, Chile
Vina Del Mar, Valparaíso, Chile
Iruma Gun, Saitama, Japan
South Jordan, Utah, United States
Markham, Ontario, Canada
Camp Hill, Pennsylvania, United States
Kyoto Shi, Kyoto, Japan
Akdeniz, , Turkey
Istanbul, , Turkey
Kayseri, , Turkey
Sahinbey, , Turkey
New Orleans, Louisiana, United States
Lee's Summit, Missouri, United States
Mesquite, Texas, United States
Layton, Utah, United States
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Capital Federal, Buenos Aires, Argentina
Santiago De Chile, , Chile
Chengdu, , China
Hangzhou, , China
Nanchang, , China
Ankara, , Turkey
Istanbul, , Turkey
Romans Sur Isère, , France
Hamburg, , Germany
Wuxi, , China
Olomouc, , Czechia
Camp Hill, Pennsylvania, United States
New Orleans, Louisiana, United States
Troy, Michigan, United States
New York, New York, United States
Caba, Buenos Aires, Argentina
San Miguel De Tucuman, , Argentina
Santo André, , Brazil
Surrey, British Columbia, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Talcahuano, , Chile
Fuzhou, , China
Hangzhou, , China
Shenyang, , China
Nantes, , France
Kobe Shi, Hyogo, Japan
Shenyang, , China
Bordeaux, , France
Rouen, , France
Buxtehude, , Germany
Praha, , Czechia
Pisa, , Italy
Magdeburg, , Germany
Mainz, , Germany
Guangzhou, , China
Sagamihara Shi, Kanagawa, Japan
Mendoza, , Argentina
Curitiba, Paraná, Brazil
Ribeirao Preto, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Tianjin, , China
Wuhan, , China
Praha 1, , Czechia
Ancona, , Italy
Sevilla, Andalucia, Spain
Bilbao, Bizkaia, Spain
Pamplona, Navarra, Spain
Burjassot Valencia, Valenciana, Comunidad, Spain
Vigo, , Spain
Shanghai, , China
Santa Ana, California, United States
Corrientes, , Argentina
Vitoria, Espírito Santo, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, , Brazil
Dupnitsa, , Bulgaria
Changsha, , China
Plzen, , Czechia
Nice, , France
Augsburg, , Germany
Granada, Andalucia, Spain
Madrid, , Spain
Istanbul, , Turkey
Chitose Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Miyagi Gun, Miyagi, Japan
Castle Rock, Colorado, United States
Miami Lakes, Florida, United States
Gretna, Louisiana, United States
Caba, Buenos Aires, Argentina
Sofia, , Bulgaria
Calgary, Alberta, Canada
Kelowna, British Columbia, Canada
Hamburg, , Germany
Witten, , Germany
L'aquila, , Italy
Manises, Valencia, Spain
Sendai Shi, Miyagi, Japan
New York, New York, United States
Mayfield Heights, Ohio, United States
Camp Hill, Pennsylvania, United States
San Miguel De Tucuman, , Argentina
Red Deer, Alberta, Canada
Camp Hill, Pennsylvania, United States
San Antonio, Texas, United States
Buenos Aires, , Argentina
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Santo André, , Brazil
Talcahuano, , Chile
Prague, , Czechia
Encino, California, United States
Los Angeles, California, United States
Saint Petersburg, Florida, United States
Tampa, Florida, United States
Skokie, Illinois, United States
Indianapolis, Indiana, United States
Omaha, Nebraska, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
São Paulo, , Brazil
Bordeaux, , France
Sakai, Osaka, Japan
Mibu, Tochigi, Japan
Tachikawa, Tokyo, Japan
Habikino, , Japan
Yokohama, , Japan
Gaziantep, , Turkey
Istanbul, , Turkey
Miami, Florida, United States
New York, New York, United States
Missouri City, Texas, United States
Birmingham, Alabama, United States
Fort Smith, Arkansas, United States
Huntington Beach, California, United States
Palmdale, California, United States
Santa Ana, California, United States
Castle Rock, Colorado, United States
Hollywood, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Dawsonville, Georgia, United States
Gretna, Louisiana, United States
New Orleans, Louisiana, United States
Troy, Michigan, United States
Ypsilanti, Michigan, United States
Lee's Summit, Missouri, United States
Las Vegas, Nevada, United States
Portsmouth, New Hampshire, United States
New York, New York, United States
New York, New York, United States
Mayfield Heights, Ohio, United States
Tulsa, Oklahoma, United States
Charleston, South Carolina, United States
Mesquite, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Bountiful, Utah, United States
Layton, Utah, United States
South Jordan, Utah, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Mendoza, , Argentina
San Miguel De Tucumán, , Argentina
Salvador, Bahia, Brazil
Vitoria, Espírito Santo, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Ribeirão Preto, São Paulo, Brazil
São Paulo, , Brazil
Pleven, , Bulgaria
Brampton, Ontario, Canada
Mississauga, Ontario, Canada
Peterborough, Ontario, Canada
Québec City, Quebec, Canada
Santiago, , Chile
Guangzhou, , China
Wuxi, , China
Nový Jičín, , Czechia
Prague, , Czechia
Nice, , France
Pierre Bénite, , France
Milan, Lombardia, Italy
Bologna, , Italy
Torette, , Italy
Chitose, Hokkaido, Japan
Obihiro, Hokkaido, Japan
Kobe, Hyogo, Japan
Sagamihara, Kanagawa, Japan
Iruma, Saitama, Japan
Chuo, Tokyo, Japan
Minato, Tokyo, Japan
Kyoto, , Japan
Kyoto, , Japan
Granada, Andalucia, Spain
Seville, Andalucia, Spain
Burjassot, Valenciana, Comunidad, Spain
Antalya, , Turkey
Istanbul, , Turkey
Samsun, , Turkey
Porto Alegre, Rio Grande Do Sul, Brazil
Pisa, , Italy
Sacramento, California, United States
New Orleans, Louisiana, United States
New York, New York, United States
Sã£O Paulo, , Brazil
Sofia, , Bulgaria
Kamloops, British Columbia, Canada
Santiago De Chile, , Chile
New York, New York, United States
Dawsonville, Georgia, United States
Kagoshima, , Japan
Camp Hill, Pennsylvania, United States
Sapporo, Hokkaido, Japan
Castle Rock, Colorado, United States
Mayfield Heights, Ohio, United States
Caba, Ciudad De Buenos Aires, Argentina
Sao Paulo, , Brazil
Pilsen, , Czechia
Miami Lakes, Florida, United States
Viña Del Mar, Valparaíso, Chile
Saint Pierre, , France
Esplugues De Llobregat, , Spain
Curitiba, , Brazil
Viña Del Mar, , Chile
Vitoria, , Brazil
Ribeirão Preto, , Brazil
Burjassot, , Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported