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
Launched by SANOFI · Jan 26, 2024
Trial Information
Current as of June 27, 2025
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 (AD), a condition that causes itchy and inflamed skin. The goal is to see if amlitelimab is effective and safe when used alongside other topical treatments that patients may already be using, especially for those who haven’t had success with previous treatments like biologic medications or oral JAK inhibitors. Participants will be randomly assigned to receive either the amlitelimab injection or a placebo (a substance with no therapeutic effect) over a period of up to 56 weeks.
To be eligible for the trial, participants must have been diagnosed with atopic dermatitis for at least a year and have had an inadequate response to earlier treatments. They should also have specific levels of skin severity and be willing to attend multiple study visits. Throughout the study, participants can expect to have a thorough screening and follow-up visits to monitor their health and any potential side effects. Additionally, those who complete the initial study may have the opportunity to join a longer-term safety study to continue monitoring the treatment's effects.
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 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:
- 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
Utrecht, , Netherlands
Hamilton, Ontario, Canada
Istanbul, , Turkey
Rosario, Santa Fe, Argentina
Melbourne, Victoria, Australia
Rosario, Santa Fe, Argentina
Santiago, Reg Metropolitana De Santiago, Chile
Hangzhou, , China
Veracruz, , Mexico
Athens, , Greece
Warszawa, Mazowieckie, Poland
Edmonton, Alberta, Canada
Berlin, , Germany
Blankenfelde Mahlow, , Germany
Yokohama Shi, Kanagawa, Japan
Sakai Shi, Osaka, Japan
Shimotsuga Gun, Tochigi, Japan
Habikino Shi, , Japan
Wroclaw, Dolnoslaskie, Poland
Warszawa, Mazowieckie, Poland
Madrid, Madrid, Comunidad De, Spain
Alicante, , Spain
London, London, City Of, United Kingdom
Shanghai, , China
Istanbul, , Turkey
Calgary, Alberta, Canada
Fremont, California, United States
New York, New York, United States
Norfolk, Virginia, United States
Salvador, Bahia, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Santo Andre, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Toronto, Ontario, 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
Lille, , France
Tachikawa Shi, Tokyo, Japan
Ansan Si, Gyeonggi Do, Korea, Republic Of
Rotterdam, , Netherlands
Badalona, Catalunya [Cataluña], Spain
Taipei, , Taiwan
Tampa, Florida, United States
Riyadh, , Saudi Arabia
Gdansk, Pomorskie, Poland
Regina, Saskatchewan, Canada
Boynton Beach, Florida, United States
Portsmouth, Hampshire, United Kingdom
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Ogden, Utah, United States
Encino, California, United States
Los Angeles, California, United States
Saint Petersburg, Florida, United States
Indianapolis, Indiana, United States
Omaha, Nebraska, United States
Thessaloniki, , Greece
Skokie, Illinois, United States
Scottsdale, Arizona, United States
Long Beach, California, United States
Ramat Gan, , Israel
Seongnam, Gyeonggi Do, Korea, Republic Of
Seoul, Gyeonggi Do, Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Sahinbey, , Turkey
Sutton In Ashfield, Nottinghamshire, United Kingdom
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Hangzhou, , China
Shenyang, , China
Bordeaux, , France
Rouen, , France
Tel Aviv, , Israel
Majadahonda, Madrid, Spain
Pozuelo De Alarcon, Madrid, Spain
Plymouth, Devon, United Kingdom
London, London, City Of, United Kingdom
Leeds, North Yorkshire, United Kingdom
Bristol, , United Kingdom
Ningbo, , China
Sao Paulo, São Paulo, Brazil
Arlington, Texas, United States
Sao Paulo, São Paulo, Brazil
Dallas, Texas, United States
Changchun, , China
Ningbo, , China
Clermont Ferrand, , France
Dresden, , Germany
Lübeck, , Germany
Abu Dhabi, , United Arab Emirates
Bradford, , United Kingdom
Liverpool, , United Kingdom
Little Rock, Arkansas, United States
Wheat Ridge, Colorado, United States
Cheyenne, Wyoming, United States
Guangzhou, , China
Nanyang, , China
Thessaloniki, , Greece
Beer Sheva, , Israel
Chieti, , Italy
Torino, , Italy
Hiroshima Shi, Hiroshima, Japan
Witten, , Germany
Metairie, Louisiana, United States
Mill Creek, Washington, United States
Cordoba, Córdoba, Argentina
London, Ontario, Canada
Toronto, Ontario, Canada
Wuhan, , China
Xi'an, , China
Athens, , Greece
Abu Dhabi, , United Arab Emirates
Fremont, California, United States
Warsaw, Mazowieckie, Poland
Fremont, California, United States
Doral, Florida, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Norfolk, Virginia, United States
Melbourne, Victoria, Australia
Salvador, Bahia, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sorocaba, São Paulo, Brazil
Santo André, , Brazil
São Paulo, , Brazil
Athens, , Greece
Be'er Sheva, , Israel
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Bupyeong Gu, , Korea, Republic Of
Kaohsiung City, , Taiwan
Taipei City, , Taiwan
Taipei, , Taiwan
Tel Aviv, , Israel
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Encino, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Wheat Ridge, Colorado, United States
Boynton Beach, Florida, United States
Saint Petersburg, Florida, United States
Tampa, Florida, United States
Skokie, Illinois, United States
Indianapolis, Indiana, United States
Metairie, Louisiana, United States
Omaha, Nebraska, United States
Arlington, Texas, United States
Dallas, Texas, United States
Ogden, Utah, United States
Mill Creek, Washington, United States
Cheyenne, Wyoming, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
Santo André, São Paulo, Brazil
São Paulo, , Brazil
Guangzhou, , China
Nanyang, , China
Ningbo, , China
Xi An, , China
Bordeaux, , France
Clermont Ferrand, , France
Blankenfelde Mahlow, , Germany
Lübeck, , Germany
Athens, , Greece
Ramat Gan, , Israel
Caserta, , Italy
Modena, , Italy
Perugia, , Italy
Turin, , Italy
Sakai, Osaka, Japan
Mibu, Tochigi, Japan
Tachikawa, Tokyo, Japan
Habikino, , Japan
Hiroshima, , Japan
Yokohama, , Japan
Rotterdam, , Netherlands
Warsaw, Mazowieckie, Poland
Pozuelo De Alarcón, Madrid, Spain
Seville, Sevilla, Spain
Gaziantep, , Turkey
Istanbul, , Turkey
Portsmouth, Hampshire, United Kingdom
Nottingham, Nottinghamshire, United Kingdom
Albuquerque, New Mexico, United States
Salvador, Bahia, Brazil
Guangzhou, , China
Porto Alegre, Rio Grande Do Sul, Brazil
Créteil, , France
Taoyuan City, , Taiwan
Boynton Beach, Florida, United States
Franklin, Kentucky, United States
North Little Rock, Arkansas, United States
New York, New York, United States
Dallas, Texas, United States
Modena, , Italy
Napoli, , Italy
Perugia, , Italy
Lublin, Lubuskie, Poland
Veracruz, , Mexico
Hangzhou, , China
Athens, , Greece
Northville, Michigan, United States
Charleston, South Carolina, United States
Milwaukee, Wisconsin, United States
Burlington, Ontario, Canada
Monterrey, Nuevo León, Mexico
Saint Pierre, , France
Ann Arbor, Michigan, United States
Portland, Oregon, United States
Charleston, South Carolina, United States
Wroclaw, , Poland
Albuquerque, New Mexico, United States
Yokohama, Kanagawa, Japan
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Badalona, Barcelona [Barcelona], Spain
Madrid, , Spain
Dallas, Texas, United States
Caba, Buenos Aires, Argentina
Saint Pierre, , France
Turin, Torino, Italy
Habikino, Osaka, Japan
Lublin, Lubelskie, Poland
Bristol, Bristol, City Of, United Kingdom
London, England, United Kingdom
London, England, United Kingdom
Albuquerque, New Mexico, United States
Skokie, Illinois, United States
Birmingham, Alabama, United States
San Diego, California, United States
Changchun, , China
Paris, , France
Naples, Napoli, Italy
Bupyeong Gu, Incheon Gwangyeoksi, Korea, Republic Of
Sorocaba, , Brazil
Badalona, , Spain
Monterrey, , Mexico
San Diego, California, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
East Windsor, New Jersey, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported