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
Launched by SANOFI · Nov 8, 2023
Trial Information
Current as of June 19, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is researching a new treatment called amlitelimab for people aged 12 and older who have moderate to severe atopic dermatitis, also known as eczema. The study aims to find out if amlitelimab is effective and safe compared to a placebo, which is like a sugar pill that has no active ingredients. Participants might be eligible if they have had atopic dermatitis for at least a year and have not had enough improvement from other treatments. Key requirements include being able to attend study visits and having certain levels of skin involvement and symptoms.
If you decide to participate, the study will last up to 44 weeks, including a 24-week treatment period where neither you nor your doctor will know if you are receiving amlitelimab or the placebo. You will have up to 10 visits during this time, and if you choose to continue in a separate follow-up study, that could last an additional 28 weeks. It's a great opportunity to help researchers learn more about treating atopic dermatitis while also receiving care for your condition.
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 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 (1 week in the event of superficial skin infections)
- • 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
Haifa, , Israel
Santiago, Reg Metropolitana De Santiago, Chile
Melbourne, Victoria, Australia
Lafayette, California, United States
Paris, , France
Santiago, Reg Metropolitana De Santiago, Chile
Hollywood, Florida, United States
Miami, Florida, United States
Athens, , Greece
Troy, Michigan, United States
Niagara Falls, Ontario, Canada
Kiel, , Germany
Münster, , Germany
Taichung, , Taiwan
Fremont, California, United States
Northridge, California, United States
Brighton, Massachusetts, United States
New York, New York, United States
Norfolk, Virginia, United States
Surrey, British Columbia, Canada
Saskatoon, Saskatchewan, Canada
Salvador, Bahia, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sorocaba, São Paulo, Brazil
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Bad Bentheim, , Germany
Ansan Si, Gyeonggi Do, Korea, Republic Of
Yangsan Si, Gyeongsangnam Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Taipei, , Taiwan
Jerusalem, , Israel
Scottsdale, Arizona, United States
Fountain Valley, California, United States
Louisville, Kentucky, United States
Charlotte, North Carolina, United States
Portland, Oregon, United States
Ajax, Ontario, Canada
Gdansk, Pomorskie, Poland
Katowice, Slaskie, Poland
Warszawa, , Poland
Warszawa, , Poland
Covington, Louisiana, United States
Lafayette, Louisiana, United States
San Antonio, Texas, United States
Woolloongabba, Queensland, Australia
East Melbourne, Victoria, Australia
Ottawa, Ontario, Canada
Regina, Saskatchewan, Canada
Daegu, Daegu Gwangyeoksi, Korea, Republic Of
Sugarloaf, Pennsylvania, United States
Hialeah, Florida, United States
Macon, Georgia, United States
Philadelphia, Pennsylvania, United States
Westmead, New South Wales, Australia
London, Ontario, Canada
Toronto, Ontario, Canada
Gwangju, Gwangju Gwangyeoksi, Korea, Republic Of
Cumming, Georgia, United States
Philadelphia, Pennsylvania, United States
Bronx, New York, United States
Southlake, Texas, United States
Traralgon West, Victoria, Australia
Edmonton, Alberta, Canada
Saint Jérôme, Quebec, Canada
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Thessaloniki, , Greece
Osorno, Reg Metropolitana De Santiago, Chile
Vina Del Mar, Valparaíso, Chile
Doral, Florida, United States
Dallas, Texas, United States
Springville, Utah, United States
Suwon, Gyeonggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Petach Tikva, , Israel
Camp Hill, Pennsylvania, United States
Thessaloniki, , Greece
Ridgeland, Mississippi, United States
Beijing, , China
Gwangju, , Korea, Republic Of
Seongnam, Gyeonggi Do, Korea, Republic Of
Incheon, Incheon Gwangyeoksi, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Chengdu, , China
Miami, Florida, United States
Orlando, Florida, United States
Addison, Texas, United States
Jinan, , China
Antony, , France
Romans Sur Isère, , France
Hamburg, , Germany
Camp Hill, Pennsylvania, United States
Santo André, , Brazil
Santiago, Reg Metropolitana De Santiago, Chile
Talcahuano, , Chile
Nantes, , France
Thomasville, Georgia, United States
Boston, Massachusetts, United States
Brighton, Massachusetts, United States
Saint Joseph, Missouri, United States
Greenville, South Carolina, United States
Buxtehude, , Germany
Tarnow, , Poland
Petah Tikva, , Israel
Detroit, Michigan, United States
Sao Paulo, São Paulo, Brazil
Rio De Janeiro, , Brazil
Chongqing, , China
Guangzhou, , China
Reims, , France
Magdeburg, , Germany
Mainz, , Germany
Ahmedabad, , India
Belagavi, , India
Nagpur, , India
Pune, , India
Afula, , Israel
Krakow, , Poland
Lodz, , Poland
Curitiba, Paraná, Brazil
Hollywood, Florida, United States
Sao Paulo, São Paulo, Brazil
Toronto, Ontario, Canada
Bengaluru, , India
Haryana, , India
Beer Sheva, , Israel
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Lublin, , Poland
Lafayette, California, United States
Lincoln, Nebraska, United States
Fairport, New York, United States
Prahran, Victoria, Australia
Chengdu, , China
Chongqing, , China
Shenzhen, , China
Kolkata, , India
Fremont, California, United States
North Hollywood, California, United States
Doral, Florida, United States
Fort Myers, Florida, United States
Caba, Buenos Aires, Argentina
Caba, Ciudad De Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Chandigarh, , India
Camp Hill, Pennsylvania, United States
Sao Luis, Maranhão, Brazil
Ottawa, Ontario, Canada
Olsztyn, , Poland
Scottsdale, Arizona, United States
Fountain Valley, California, United States
Fremont, California, United States
Lafayette, California, United States
North Hollywood, California, United States
Northridge, California, United States
Doral, Florida, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Cumming, Georgia, United States
Macon, Georgia, United States
Thomasville, Georgia, United States
Union City, Georgia, United States
Louisville, Kentucky, United States
Covington, Louisiana, United States
Lafayette, Louisiana, United States
Boston, Massachusetts, United States
Needham, Massachusetts, United States
Dearborn, Michigan, United States
Detroit, Michigan, United States
Ridgeland, Mississippi, United States
Saint Joseph, Missouri, United States
Lincoln, Nebraska, United States
Bronx, New York, United States
Fairport, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Portland, Oregon, United States
Camp Hill, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Greenville, South Carolina, United States
Addison, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Southlake, Texas, United States
Springville, Utah, United States
Norfolk, Virginia, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Buenos Aires, , Argentina
Melbourne, Victoria, Australia
Traralgon, Victoria, Australia
Salvador, Bahia, Brazil
Bequimão, Maranhão, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sorocaba, São Paulo, Brazil
Rio De Janeiro, , Brazil
Santo André, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
Saskatoon, Saskatchewan, Canada
Talcahuano, , Chile
Chongqing, , China
Jinan, , China
Athens, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Afula, , Israel
Be'er Sheva, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Petah Tikva, , Israel
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Suwon Si, Gyeonggi Do, Korea, Republic Of
Yangsan Si, Gyeongsangnam Do, Korea, Republic Of
Bupyeong Gu, Incheon Gwangyeoksi, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Krakow, , Poland
Lodz, , Poland
Warsaw, , Poland
Warsaw, , Poland
Kaohsiung City, , Taiwan
Taipei City, , Taiwan
Taipei, , Taiwan
Athens, , Greece
Salvador, Bahia, Brazil
Lafayette, California, United States
Northridge, California, United States
Dearborn, Michigan, United States
Ridgeland, Mississippi, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Taoyuan City, , Taiwan
Doral, Florida, United States
North Hollywood, California, United States
Union City, Georgia, United States
Lafayette, Louisiana, United States
Greenville, South Carolina, United States
Springville, Utah, United States
Buenos Aires, , Argentina
Sao Paulo, São Paulo, Brazil
Rio De Janeiro, , Brazil
Lublin, , Poland
Olsztyn, , Poland
Southlake, Texas, United States
Ottawa, Ontario, Canada
Fort Myers, Florida, United States
Thomasville, Georgia, United States
Lafayette, Louisiana, United States
Dallas, Texas, United States
San Miguel De Tucumán, Tucumán, Argentina
Curitiba, Paraná, Brazil
Hamilton, Ontario, Canada
Orlando, Florida, United States
Charlotte, North Carolina, United States
Camp Hill, Pennsylvania, United States
Sao Paulo, São Paulo, Brazil
Taoyuan County, , Taiwan
Viña Del Mar, Valparaíso, Chile
Macon, Georgia, United States
San Miguel De Tucumã¡N, Tucumán, Argentina
Toronto, Ontario, Canada
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported