A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Launched by SANOFI · May 6, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is designed to evaluate how well two different doses of a medication called amlitelimab work for people aged 12 years and older with moderate-to-severe atopic dermatitis, a condition that causes itchy and inflamed skin. The study aims to find out if participants who responded well to an initial dose of amlitelimab can continue to improve by either staying on that dose or switching to a higher dose, compared to those who stop the treatment altogether. The trial will last up to 64 weeks, including a 48-week period where neither the participants nor the researchers will know who is receiving the treatment or a placebo (a dummy treatment), followed by 16 weeks of safety monitoring.
To participate, individuals need to be at least 12 years old and have completed a previous study treatment without any major issues. They also need to weigh at least 25 kg (about 55 pounds). Participants will have up to 14 visits throughout the study, where they will receive the treatment and undergo assessments to monitor their condition. It's important to note that certain medical conditions or previous adverse reactions to the treatment may disqualify someone from joining the trial. If you or someone you know might be interested, it’s a great opportunity to contribute to research that could help others with atopic dermatitis.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
- • Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
- • Able and willing to comply with requested study visit and procedures.
- • Body weight must be ≥ 25 kg.
- 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 Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.
- • Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
- • Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
- • Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
- • Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
- • Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- • 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
Haifa, , Israel
Rosario, Santa Fe, Argentina
Santiago, Reg Metropolitana De Santiago, Chile
Melbourne, Victoria, Australia
Lafayette, California, United States
Rosario, Santa Fe, Argentina
Paris, , France
Santiago, Reg Metropolitana De Santiago, Chile
Hollywood, Florida, United States
Miami, Florida, United States
Hangzhou, , China
Sofia, , Bulgaria
Markham, Ontario, Canada
Niagara Falls, Ontario, Canada
Waterloo, Ontario, Canada
Ostrava, , Czechia
Kiel, , Germany
Münster, , Germany
Obihiro Shi, Hokkaido, Japan
Kagoshima Shi, Kagoshima, Japan
Yokohama Shi, Kanagawa, Japan
Minato Ku, Tokyo, Japan
Madrid, Madrid, Comunidad De, Spain
Alicante, , Spain
Taichung, , Taiwan
London, London, City Of, United Kingdom
Shanghai, , China
Istanbul, , Turkey
Rapid City, South Dakota, United States
Aarhus, , Denmark
Fremont, California, United States
Northridge, California, United States
New York, New York, United States
Norfolk, Virginia, United States
Surrey, British Columbia, Canada
Saskatoon, Saskatchewan, Canada
Toronto, Ontario, Canada
Quebec, , 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
Toulouse, , France
Bad Bentheim, , Germany
Tachikawa Shi, Tokyo, Japan
Ansan Si, Gyeonggi Do, Korea, Republic Of
Yangsan Si, Gyeongsangnam Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Durban, , South Africa
Scottsdale, Arizona, United States
Louisville, Kentucky, United States
Portland, Oregon, United States
Ajax, Ontario, Canada
Katowice, Slaskie, Poland
Woolloongabba, Queensland, Australia
Regina, Saskatchewan, Canada
Daegu, Daegu Gwangyeoksi, Korea, Republic Of
Plymouth Meeting, Pennsylvania, United States
Missouri City, Texas, United States
Arlington, Virginia, United States
Glasgow, , United Kingdom
Hialeah, Florida, United States
Philadelphia, Pennsylvania, United States
Westmead, New South Wales, Australia
London, Ontario, Canada
Toronto, Ontario, Canada
Gwangju, Gwangju Gwangyeoksi, Korea, Republic Of
Encino, California, United States
Huntington Beach, California, United States
Los Angeles, California, United States
Ypsilanti, Michigan, United States
Winnipeg, Manitoba, Canada
Richmond Hill, Ontario, Canada
Benoni, , South Africa
Southlake, Texas, United States
Edmonton, Alberta, Canada
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Osorno, Reg Metropolitana De Santiago, Chile
Vina Del Mar, Valparaíso, Chile
Suwon, Gyeonggi Do, Korea, Republic Of
Leicester, , United Kingdom
Herlev, , Denmark
Granada, , Spain
Kayseri, , Turkey
Ridgeland, Mississippi, United States
Beijing, , China
Gwangju, , Korea, Republic Of
Seongnam, Gyeonggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Mesquite, Texas, United States
Chengdu, , China
Hangzhou, , China
Nanchang, , China
Istanbul, , Turkey
Antony, , France
Romans Sur Isère, , France
Hamburg, , Germany
Beijing, , China
Beijing, , China
Chengdu, , China
Guangzhou, , China
Jinan, , China
Olomouc, , Czechia
Durban, , South Africa
Las Palmas De Gran Canaria, Las Palmas, Spain
Alvsjo, , Sweden
Surrey, British Columbia, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Fuzhou, , China
Hangzhou, , China
Shenyang, , China
Rouen, , France
Brighton, Massachusetts, United States
Tarnow, , Poland
Hangzhou, , China
Ningbo, , China
Aalborg, , Denmark
Pisa, , Italy
Porto, , Portugal
Chongqing, , China
Guangzhou, , China
Reims, , France
Mainz, , Germany
Ahmedabad, , India
Belagavi, , India
Pune, , India
Wuhan, , China
Bilbao, Bizkaia, Spain
Pamplona, Navarra, Spain
Vigo, , Spain
Hollywood, Florida, United States
Haryana, , India
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Shanghai, , China
Catania, , Italy
Corrientes, , Argentina
Dupnitsa, , Bulgaria
Changsha, , China
Augsburg, , Germany
Lafayette, California, United States
Dearborn, Michigan, United States
Chengdu, , China
Shenzhen, , China
Kolkata, , India
Miyagi Gun, Miyagi, Japan
Monterrey, Nuevo León, Mexico
Durango, , Mexico
Calgary, Alberta, Canada
Kelowna, British Columbia, Canada
Hamburg, , Germany
L'aquila, , Italy
Chandigarh, , India
Quillota, Valparaíso, Chile
Aguascalientes, , Mexico
Ottawa, Ontario, Canada
Scottsdale, Arizona, United States
Fountain Valley, California, United States
Fremont, California, United States
Doral, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Cumming, Georgia, United States
Louisville, Kentucky, United States
Covington, Louisiana, United States
Needham, Massachusetts, United States
Detroit, Michigan, United States
New York, New York, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Southlake, Texas, United States
Norfolk, Virginia, United States
Buenos Aires, , Argentina
Melbourne, Victoria, Australia
Traralgon, Victoria, Australia
Bequimão, Maranhão, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sorocaba, São Paulo, Brazil
Santo André, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
Saskatoon, Saskatchewan, Canada
Talcahuano, , Chile
Chongqing, , China
Athens, , Greece
Thessaloniki, , Greece
Afula, , Israel
Be'er Sheva, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Petah Tikva, , Israel
Suwon Si, Gyeonggi Do, Korea, Republic Of
Yangsan Si, Gyeongsangnam Do, Korea, Republic Of
Bupyeong Gu, , 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
Prague, , Czechia
Scottsdale, Arizona, United States
Encino, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Saint Petersburg, Florida, United States
Skokie, Illinois, United States
Indianapolis, Indiana, United States
Omaha, Nebraska, United States
Arlington, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Santo André, São Paulo, Brazil
São Paulo, , Brazil
Sakai, Osaka, Japan
Mibu, Tochigi, Japan
Tachikawa, Tokyo, Japan
Habikino, , Japan
Yokohama, , Japan
Seville, Sevilla, Spain
Gaziantep, , Turkey
Portsmouth, Hampshire, United Kingdom
Santa Monica, California, United States
Tucson, Arizona, United States
Oxnard, California, United States
Farmington, Connecticut, United States
Coral Gables, Florida, United States
Pompano Beach, Florida, United States
Fargo, North Dakota, United States
Bexley, Ohio, United States
Plymouth Meeting, Pennsylvania, United States
Rapid City, South Dakota, United States
Houston, Texas, United States
Missouri City, Texas, United States
Arlington, Virginia, United States
Birmingham, Alabama, United States
Fort Smith, Arkansas, United States
Huntington Beach, California, United States
Santa Ana, California, United States
Miami, Florida, United States
Gretna, Louisiana, United States
Troy, Michigan, United States
Ypsilanti, Michigan, United States
Las Vegas, Nevada, United States
New York, New York, United States
New York, New York, United States
Mayfield Heights, Ohio, United States
Tulsa, Oklahoma, United States
Mesquite, Texas, United States
Sugar Land, Texas, United States
Bountiful, Utah, United States
Layton, Utah, United States
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
Mississauga, Ontario, Canada
Québec City, Quebec, Canada
Guangzhou, , China
Wuxi, , China
Nový Jičín, , Czechia
Prague, , Czechia
Nice, , France
Pierre Bénite, , France
Milan, Lombardia, Italy
Bologna, , 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
Burjassot, Valenciana, Comunidad, Spain
Antalya, , Turkey
Samsun, , Turkey
Buenos Aires, , Argentina
Lafayette, California, United States
Lomita, California, United States
Northridge, California, United States
Tampa, Florida, United States
Dearborn, Michigan, United States
Ridgeland, Mississippi, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Shenyang, , China
Buenos Aires, Ciudad De Buenos Aires, Argentina
Porto Alegre, Rio Grande Do Sul, Brazil
Zhenjiang, , China
Prague, , Czechia
Cape Town, , South Africa
Cape Town, , South Africa
Johannesburg, , South Africa
Doral, Florida, United States
Kutná Hora, , Czechia
Krakow, Malopolskie, Poland
Union City, Georgia, United States
Lafayette, Louisiana, United States
Buenos Aires, , Argentina
Rio De Janeiro, , Brazil
Lublin, , Poland
Fayetteville, Georgia, United States
Hoboken, New Jersey, United States
Columbia, South Carolina, United States
Houston, Texas, United States
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Wenzhou, , China
Rome, Roma, Italy
Lisbon, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Johannesburg, , South Africa
Lomita, California, United States
New York, New York, United States
New York, New York, United States
Miami Lakes, Florida, United States
Dawsonville, Georgia, United States
Detroit, Michigan, United States
Southlake, Texas, United States
Arlington, Virginia, United States
Ottawa, Ontario, Canada
Kagoshima, , Japan
Pretoria, , South Africa
Thomasville, Georgia, United States
Lafayette, Louisiana, United States
Veracruz, , Mexico
Camp Hill, Pennsylvania, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Berazategui, Buenos Aires, Argentina
Santiago, Reg Metropolitana De Santiago, Chile
Sapporo, Hokkaido, Japan
Pilsen, , Czechia
Viña Del Mar, Valparaíso, Chile
Osorno, Los Lagos, Chile
Oxnard, California, United States
Miami Lakes, Florida, United States
Dearborn, Michigan, United States
Santiago, Reg Metropolitana De Santiago, Chile
Nagpur, , India
Rozzano, Milano, Italy
Spartanburg, South Carolina, United States
London, London, City Of, United Kingdom
Sendai, Miyagi, Japan
Miami, Florida, United States
Boston, Massachusetts, United States
Buenos Aires, , Argentina
Ottawa, Ontario, Canada
Markham, , Canada
Orebro, , Sweden
Taipei City, , Taiwan
Buenos Aires, , Argentina
Milan, Milano, Italy
Yokohama, Kanagawa, Japan
Warsaw, Mazowieckie, Poland
Warsaw, Mazowieckie, Poland
Madrid, , Spain
Caba, Buenos Aires, Argentina
Habikino, Osaka, Japan
Hollywood, Florida, United States
Macon, Georgia, United States
San Miguel De Tucumán, Tucumán, Argentina
Buenos Aires, , Argentina
Talcahuano, Biobío, Chile
Lublin, Lubelskie, Poland
Lodz, Lódzkie, Poland
Tarnow, Malopolskie, Poland
Bilbao, Pais Vasco, Spain
Vigo, Pontevedra [Pontevedra], Spain
Burjassot, Valencia, Spain
Granada, , Spain
Skokie, Illinois, United States
Red Deer, , Canada
Taipei, , Taiwan
Arlington, Virginia, United States
Bupyeong Gu, Incheon Gwangyeoksi, Korea, Republic Of
London, , United Kingdom
Sorocaba, , Brazil
Valdivia, , Chile
Bequimão, , Brazil
Curitiba, , Brazil
Viña Del Mar, , Chile
Quillota, , Chile
Monterrey, , Mexico
Vitoria, , Brazil
Ribeirão Preto, , Brazil
London, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported