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 October 03, 2024

Recruiting

Keywords

Description

No description provided

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 Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Istanbul, , Turkey

Chuo Ku, Tokyo, Japan

Santiago, Reg Metropolitana De Santiago, Chile

Esplugues De Llobregat, Catalunya [Cataluña], Spain

Pleven, , Bulgaria

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

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

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0