Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
Launched by SANOFI · Aug 5, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called amlitelimab for people aged 12 and older who have moderate to severe atopic dermatitis (a type of skin condition that causes itching and inflammation). The study is for participants who have previously been part of other trials involving amlitelimab. It aims to understand how safe and effective this treatment is over a longer period. Participants will have regular check-ups every four weeks, and if someone starts to have symptoms again after stopping the treatment, they can resume taking it.
To be eligible for this trial, participants must have completed a previous study involving amlitelimab and meet certain health criteria, such as being at least 25 kg (about 55 pounds) in weight. They should not have serious health issues that could affect their participation, like certain infections or recent substance abuse. Participants can expect to either continue receiving the treatment or go without it for a while, depending on their previous responses. The trial also allows for remote visits, meaning some check-ups can happen at home. Overall, the study is designed to closely monitor participants' health and responses to the treatment while ensuring their safety.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participant must be at least 12 years of age inclusive at the time of signing the informed consent.
- • Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period.
- • Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600
- * Participants in DRI17366 must only be enrolled from 1 of the following 3 groups:
- • The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2.
- • The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52.
- • The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up.
- • Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit
- • Complied with the previous clinical trial protocol to the satisfaction of the investigator
- • Body weight must be ≥25 kg
- * Provided signed informed assent/or consent and able to comply with the requirements of the protocol Exclusion Criteria:
- Participants are excluded from the study if any of the following criteria apply:
- • Developed a medical condition that would preclude participation as described in the section for permanent discontinuation of the feeder study or LTS17367 protocol
- • Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
- • History of solid organ or stem cell transplant
- • 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)
- • Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA PCR test
- • History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- • Participants with active 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
- * Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met:
- • 1. Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection
- • 2. Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant
- • 3. For whom review and approval from Sponsor have been granted are eligible
- • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
- • Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment
- • Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments
- • In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis
- • The above information is not intended to contain all considerations relevant to a patient'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
East Melbourne, Victoria, Australia
Carlton, Victoria, Australia
Parkville, Victoria, Australia
Pleven, , Bulgaria
Pontevedra, Galicia [Galicia], Spain
Córdoba, , Spain
Miami, Florida, United States
Tampa, Florida, United States
Troy, Michigan, United States
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Gyula, , Hungary
Szolnok, , Hungary
Wroclaw, Dolnoslaskie, Poland
Lã³dz, Lódzkie, Poland
Warszawa, Mazowieckie, Poland
Gdansk, Pomorskie, Poland
Gdansk, Pomorskie, Poland
Gdynia, Pomorskie, Poland
Katowice, Slaskie, Poland
Szczecin, Zachodniopomorskie, Poland
Madrid, Madrid, Comunidad De, Spain
Savannah, Georgia, United States
Sofia, , Bulgaria
Windsor, Ontario, Canada
Brno, , Czechia
Ostrava, , Czechia
Praha 10, , Czechia
Praha 2, , Czechia
Obihiro Shi, Hokkaido, Japan
Kagoshima Shi, Kagoshima, Japan
Kyoto Shi, Kyoto, Japan
Sakai Shi, Osaka, Japan
Setagaya Ku, Tokyo, Japan
Wroclaw, Dolnoslaskie, Poland
Lódz, Lódzkie, Poland
Lódz, Lódzkie, Poland
Krakow, Malopolskie, Poland
Kraków, Malopolskie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Rzeszow, Podkarpackie, Poland
Gdynia, Pomorskie, Poland
Krakow, , Poland
Krakow, , Poland
Alicante, , Spain
Kaohsiung, , Taiwan
Taichung, , Taiwan
Taoyuan, , Taiwan
Markham, Ontario, Canada
Niagara Falls, Ontario, Canada
Waterloo, Ontario, Canada
Kutna Hora, , Czechia
Praha 3, , Czechia
Debrecen, , Hungary
Yokohama Shi, Kanagawa, Japan
Adachi Ku, Tokyo, Japan
Edogawa Ku, Tokyo, Japan
Minato Ku, Tokyo, Japan
Habikino Shi, , Japan
Wroclaw, Dolnoslaskie, Poland
Warszawa, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
London, London, City Of, United Kingdom
Baltimore, Maryland, United States
Tulsa, Oklahoma, United States
Murfreesboro, Tennessee, United States
Berlin, , Germany
Gera, , Germany
Sapporo, Hokkaido, Japan
Shimotsuga Gun, Tochigi, Japan
Chuo Ku, Tokyo, Japan
Tao Yuan County, , Taiwan
London, London, City Of, United Kingdom
Troy, Michigan, United States
Blankenfelde Mahlow, , Germany
Kiel, , Germany
Münster, , Germany
Habikino Shi, , Japan
Kyoto Shi, , Japan
Kraków, Malopolskie, Poland
Szczecin, Zachodniopomorskie, Poland
Kaohsiung Hsien,, , Taiwan
London, City Of London, United Kingdom
London, City Of London, United Kingdom
Kaohsiung Hsien, , Taiwan
Barrie, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Rosario, Santa Fe, Argentina
Lafayette, California, United States
Santiago, Reg Metropolitana De Santiago, Chile
Miami, Florida, United States
Miami, Florida, United States
Edmonton, Alberta, Canada
Miami, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Baltimore, Maryland, United States
Troy, Michigan, United States
Tulsa, Oklahoma, United States
Murfreesboro, Tennessee, United States
Carlton, Victoria, Australia
East Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Markham, Ontario, Canada
Niagara Falls, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Brno, , Czechia
Kutna Hora, , Czechia
Ostrava, , Czechia
Praha 10, , Czechia
Praha 2, , Czechia
Praha 3, , Czechia
Berlin, , Germany
Blankenfelde Mahlow, , Germany
Gera, , Germany
Kiel, , Germany
Münster, , Germany
Debrecen, , Hungary
Gyula, , Hungary
Szolnok, , Hungary
Obihiro Shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kagoshima Shi, Kagoshima, Japan
Yokohama Shi, Kanagawa, Japan
Sakai Shi, Osaka, Japan
Shimotsuga Gun, Tochigi, Japan
Adachi Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Edogawa Ku, Tokyo, Japan
Minato Ku, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Habikino Shi, , Japan
Kyoto Shi, , Japan
Wroclaw, Dolnoslaskie, Poland
Wroclaw, Dolnoslaskie, Poland
Wroclaw, Dolnoslaskie, Poland
Lódz, Lódzkie, Poland
Lódz, Lódzkie, Poland
Krakow, Malopolskie, Poland
Kraków, Malopolskie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Rzeszow, Podkarpackie, Poland
Bialystok, Podlaskie, Poland
Gdansk, Pomorskie, Poland
Gdansk, Pomorskie, Poland
Gdynia, Pomorskie, Poland
Katowice, Slaskie, Poland
Szczecin, Zachodniopomorskie, Poland
Krakow, , Poland
Krakow, , Poland
Pontevedra, Galicia [Galicia], Spain
Madrid, Madrid, Comunidad De, Spain
Alicante, , Spain
Córdoba, , Spain
Kaohsiung Hsien,, , Taiwan
Taichung, , Taiwan
Tao Yuan County, , Taiwan
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Istanbul, , Turkey
Doral, Florida, United States
Tampa, Florida, United States
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Lille, , France
Ansan Si, Gyeonggi Do, Korea, Republic Of
Fountain Valley, California, United States
Louisville, Kentucky, United States
Boynton Beach, Florida, United States
Dallas, Texas, United States
Richmond Hill, Ontario, Canada
Kyoto Shi, Kyoto, Japan
Habikino Shi, , Japan
Baton Rouge, Louisiana, United States
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Doral, Florida, United States
Lomita, California, United States
Markham, Ontario, Canada
Henderson, Nevada, United States
Camp Hill, Pennsylvania, United States
Bristol, , United Kingdom
Miami, Florida, United States
Rzeszów, Podkarpackie, Poland
Liverpool, , United Kingdom
Torino, , Italy
Lafayette, California, United States
Sofia, , Bulgaria
Wuhan, , China
Camp Hill, Pennsylvania, United States
Fountain Valley, California, United States
Lafayette, California, United States
Miami, Florida, United States
Louisville, Kentucky, United States
Camp Hill, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Norfolk, Virginia, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Santo André, , Brazil
São Paulo, , Brazil
Bupyeong Gu, , Korea, Republic Of
Kaohsiung City, , Taiwan
Taipei City, , Taiwan
Scottsdale, Arizona, United States
Encino, California, United States
Long Beach, California, United States
Boynton Beach, Florida, United States
Saint Petersburg, Florida, United States
Arlington, Texas, United States
Buenos Aires, , Argentina
Córdoba, , Argentina
Santo André, São Paulo, Brazil
São Paulo, , Brazil
Guangzhou, , China
Ningbo, , China
Blankenfelde Mahlow, , Germany
Lübeck, , Germany
Ramat Gan, , Israel
Sakai, Osaka, Japan
Mibu, Tochigi, Japan
Tachikawa, Tokyo, Japan
Habikino, , Japan
Hiroshima, , Japan
Yokohama, , Japan
Warsaw, Mazowieckie, Poland
Portsmouth, Hampshire, United Kingdom
Nottingham, Nottinghamshire, United Kingdom
Lomita, California, United States
Santa Monica, California, United States
Doral, Florida, United States
Doral, Florida, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Henderson, Nevada, United States
Rochester, New York, United States
Tulsa, Oklahoma, United States
Murfreesboro, Tennessee, United States
Dallas, Texas, United States
Tao Yuan County, , Taiwan
Gretna, Louisiana, United States
Salvador, Bahia, Brazil
Pleven, , Bulgaria
Obihiro, Hokkaido, Japan
Minato, Tokyo, Japan
Kyoto, , Japan
Lafayette, California, United States
Lomita, California, United States
Tampa, Florida, United States
Prague, , Czechia
Taoyuan City, , Taiwan
Birmingham, Alabama, United States
Anaheim, California, United States
Lancaster, California, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Rochester, New York, United States
Dallas, Texas, United States
Calgary, Alberta, Canada
Boynton Beach, Florida, United States
Doral, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Henderson, Nevada, United States
Tulsa, Oklahoma, United States
Murfreesboro, Tennessee, United States
Melbourne, Victoria, Australia
Brno, , Czechia
Kutná Hora, , Czechia
Prague, , Czechia
Prague, , Czechia
Edogawa, Tokyo, Japan
Setagaya, Tokyo, Japan
Tokyo, , Japan
Wroclaw, Dolnoslaskie, Poland
Lodz, Lódzkie, Poland
Lodz, Lódzkie, Poland
Krakow, Malopolskie, Poland
Warsaw, Mazowieckie, Poland
Warsaw, Mazowieckie, Poland
Gdansk, Pomorskie, Poland
Krakow, , Poland
Southlake, Texas, United States
Kagoshima, , Japan
Kendall, Florida, United States
Baltimore, Maryland, United States
Chuo, Tokyo, Japan
Krakow, Malopolskie, Poland
Camp Hill, Pennsylvania, United States
Szczecin, Zachodniopomorskie, Poland
Pontevedra, Galicia [Galicia], Spain
Anaheim, California, United States
Troy, Michigan, United States
Madrid, , Spain
Dallas, Texas, United States
Missoula, Montana, United States
Chicago, Illinois, United States
Abu Dhabi, , United Arab Emirates
Baton Rouge, Louisiana, United States
Rapid City, South Dakota, United States
Cheyenne, Wyoming, United States
Bupyeong Gu, Incheon Gwangyeoksi, Korea, Republic Of
Lodz, , Poland
Lodz, , Poland
Pontevedra, , Spain
London, , United Kingdom
London, , United Kingdom
London, , Canada
Saskatoon, , Canada
Surrey, , Canada
Miami Lakes, Florida, United States
Towson, Maryland, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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