Search / Trial NCT06224348

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 December 30, 2024

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.

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

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

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0