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Search / Trial NCT05704738

A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

Launched by AMGEN · Jan 20, 2023

Trial Information

Current as of June 04, 2025

Active, not recruiting

Keywords

Atopic Dermatitis Amg 451 Khk4083 Rocatinlimab

ClinConnect Summary

This clinical trial is studying a new treatment called rocatinlimab for adolescents aged 12 to 17 who have moderate to severe atopic dermatitis, which is a skin condition that can cause intense itching and rashes. The goal is to see how well rocatinlimab works on its own and when combined with other treatments. To participate, young people need to have had atopic dermatitis for at least a year, weigh at least 40 kg, and not have responded well to standard treatments like medium to strong topical corticosteroids.

Participants in the trial can expect to receive either the new treatment or a combination of treatments while being closely monitored for safety and effectiveness. It’s important to note that there are specific criteria that must be met to join the study, such as not having used certain medications, like systemic corticosteroids or other treatments, for a set period before starting the trial. This helps ensure that the results are accurate and safe for the participants.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 12 to \< 18 years at Day 1.
  • Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield et al, 2014\]) that has been present for at least 12 months before signing of informed consent.
  • Body weight ≥ 40 kg at screening.
  • History of inadequate response to TCS of medium to higher potency (with or without TCI).
  • EASI score ≥ 12 at initial screening.
  • EASI score ≥ 16 at Day 1.
  • vIGA-AD score ≥ 3.
  • ≥10% body surface area of AD involvement.
  • Worst pruritus NRS ≥ 4.
  • Exclusion Criteria:
  • Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1.
  • * Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
  • 1. Systemic corticosteroids
  • 2. Non-biologic, non-targeted systemic immunosuppressants
  • 3. Phototherapy
  • 4. Oral or Topical Janus kinase inhibitors
  • * Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
  • 1. TCS of any potency
  • 2. TCI
  • 3. Topical phosphodiesterase 4 inhibitors
  • 4. Other topical immunosuppressive agents

About Amgen

Amgen is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong focus on areas such as oncology, cardiovascular disease, and inflammation, Amgen leverages advanced science and technology to address complex medical needs. The company is committed to improving patient outcomes through rigorous clinical trials and robust research initiatives, ensuring the highest standards of safety and efficacy in its products. With a rich pipeline of cutting-edge therapies, Amgen continues to be at the forefront of biopharmaceutical advancements, making a significant impact on healthcare worldwide.

Locations

Tampa, Florida, United States

Charleston, South Carolina, United States

Bangkok, , Thailand

Madrid, , Spain

Madrid, , Spain

Detroit, Michigan, United States

Houston, Texas, United States

Albuquerque, New Mexico, United States

Saint Louis, Missouri, United States

Portland, Oregon, United States

Rochester, New York, United States

Oklahoma City, Oklahoma, United States

Saint Louis, Missouri, United States

Washington, District Of Columbia, United States

Bruxelles, , Belgium

Gent, , Belgium

Taipei, , Taiwan

Detroit, Michigan, United States

Bad Bentheim, , Germany

Seoul, , Korea, Republic Of

Zagreb, , Croatia

San Diego, California, United States

Porto Alegre, Rio Grande Do Sul, Brazil

Bangkok, , Thailand

Tucson, Arizona, United States

Madrid, , Spain

Seoul, , Korea, Republic Of

North Charleston, South Carolina, United States

Indianapolis, Indiana, United States

Seoul, , Korea, Republic Of

Gdansk, , Poland

Dresden, , Germany

Santa Monica, California, United States

Erlangen, , Germany

Bellevue, Washington, United States

Taipei, , Taiwan

Pamplona, Navarra, Spain

Zagreb, , Croatia

Beijing, Beijing, China

Seoul, , Korea, Republic Of

Chiang Mai, , Thailand

Barcelona, Cataluña, Spain

Changchun, , China

Sugar Land, Texas, United States

Beijing, , China

Seoul, , Korea, Republic Of

Birmingham, Alabama, United States

Shinagawa Ku, Tokyo, Japan

Changchun, Jilin, China

Kaohsiung, , Taiwan

Debrecen, , Hungary

Wuhan, Hubei, China

Osijek, , Croatia

Saint Joseph, Missouri, United States

Changchun, Jilin, China

Milano, , Italy

Reno, Nevada, United States

Nantes, , France

Wuhan, Hubei, China

Hamamatsu Shi, Shizuoka, Japan

Brandon, Florida, United States

Bonn, , Germany

Seoul, , Korea, Republic Of

Porto Alegre, Rio Grande Do Sul, Brazil

Guangzhou, Guangdong, China

Tel Aviv, , Israel

Seoul, , Korea, Republic Of

Ramat Gan, , Israel

Setagaya Ku, Tokyo, Japan

San Antonio, Texas, United States

Kaposvar, , Hungary

Hialeah, Florida, United States

Taoyuan, , Taiwan

Thessaloniki, , Greece

Taizhou, Zhejiang, China

Seoul, , Korea, Republic Of

Santiago, , Chile

Bruxelles, , Belgium

Kerrville, Texas, United States

Seoul, , Korea, Republic Of

Katowice, , Poland

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Budapest, , Hungary

Meridian, Idaho, United States

Esplugues De Llobregat, Cataluña, Spain

Rennes Cedex 9, , France

Beijing, Beijing, China

Liege, , Belgium

Perugia, , Italy

Seoul, , Korea, Republic Of

Miami, Florida, United States

Shanghai, Shanghai, China

Miami Lakes, Florida, United States

Yokohama Shi, Kanagawa, Japan

Yokohama Shi, Kanagawa, Japan

Neyagawa Shi, Osaka, Japan

Mesquite, Texas, United States

Kew Gardens, New York, United States

Tulsa, Oklahoma, United States

Barcelona, Cataluña, Spain

Warszawa, , Poland

Wuhan, , China

São José Do Rio Preto, São Paulo, Brazil

Sandy Springs, Georgia, United States

Summerville, South Carolina, United States

East Syracuse, New York, United States

Pathum Thani, , Thailand

Flint, Michigan, United States

Laguna Niguel, California, United States

North Little Rock, Arkansas, United States

Philadelphia, Pennsylvania, United States

San Juan, , Puerto Rico

Markham, Ontario, Canada

Obihiro Shi, Hokkaido, Japan

Darmstadt, , Germany

Sacramento, California, United States

Rio De Janeiro, , Brazil

Athens, , Greece

Auburn Hills, Michigan, United States

Asahikawa Shi, Hokkaido, Japan

South Jordan, Utah, United States

Saskatoon, Saskatchewan, Canada

Guangzhou, Guangdong, China

Portsmouth, New Hampshire, United States

Kew Gardens, New York, United States

Lodz, , Poland

Inglewood, California, United States

Palmdale, California, United States

Birmingham, Alabama, United States

Warszawa, , Poland

Bellaire, Texas, United States

Cypress, Texas, United States

Boise, Idaho, United States

Niagara Falls, Ontario, Canada

Mainz, , Germany

Sakai Shi, Osaka, Japan

Lincoln, Nebraska, United States

Yinchuan, Ningxia, China

Seoul, , Korea, Republic Of

Rockville, Maryland, United States

Denver, Colorado, United States

Plainfield, Indiana, United States

Tulsa, Oklahoma, United States

Delray Beach, Florida, United States

Shanghai, , China

Boardman, Ohio, United States

Skokie, Illinois, United States

Murray, Kentucky, United States

Suining, Sichuan, China

Windsor, Ontario, Canada

Kumamoto Shi, Kumamoto, Japan

Miami Lakes, Florida, United States

Beijing, , China

Sacramento, California, United States

Savannah, Georgia, United States

Rockville, Maryland, United States

Murray, Utah, United States

Fukuoka Shi, Fukuoka, Japan

Kagoshima Shi, Kagoshima, Japan

Kumamoto Shi, Kumamoto, Japan

Fremont, California, United States

Margate, Florida, United States

Grants Pass, Oregon, United States

Cedar Park, Texas, United States

Matsudo Shi, Chiba, Japan

Ansansi, Gyeonggido, , Korea, Republic Of

Seoul, , Korea, Republic Of

Clearwater, Florida, United States

Orlando, Florida, United States

Nagoya Shi, Aichi, Japan

San Juan, , Puerto Rico

Mesquite, Texas, United States

Lublin, , Poland

Sherman Oaks, California, United States

Mayfield Heights, Ohio, United States

Debrecen, , Hungary

Tarnow, , Poland

Leipzig, , Germany

Kaposvar, , Hungary

Akashi Shi, Hyogo, Japan

Obihiro Shi, Hokkaido, Japan

Windsor, Ontario, Canada

Maldegem, , Belgium

Lodz, , Poland

Warszawa, , Poland

Bucharest, , Romania

Cluj Napoca, , Romania

Antony, , France

Brest, , France

Ivanic Grad, , Croatia

Athens, , Greece

Monroe, Louisiana, United States

Mayfield Heights, Ohio, United States

Oklahoma City, Oklahoma, United States

Marseille Cedex 08, , France

Rouen Cedex, , France

Toulouse, , France

Frankfurt Am Main, , Germany

Athens, , Greece

Torino, , Italy

Krakow, , Poland

Lodz, , Poland

Warszawa, , Poland

Cluj Napoca, , Romania

Orlando, Florida, United States

Marseille Cedex 8, , France

Gdansk, , Poland

New Albany, Indiana, United States

Nanyang, Henan, China

Coral Springs, Florida, United States

Doral, Florida, United States

Orange City, Florida, United States

Bronx, New York, United States

Houston, Texas, United States

Guangzhou, Guangdong, China

Durham, North Carolina, United States

Zagreb, , Croatia

Hangzhou, Zhejiang, China

Brooklyn, New York, United States

Changsha, , China

Chickasha, Oklahoma, United States

Salvador, Bahia, Brazil

Santiago, , Chile

Thessaloniki, , Greece

Dalian, , China

Missouri City, Texas, United States

Savannah, Georgia, United States

Mayfield Heights, Ohio, United States

Franklin, Virginia, United States

Vitória, Espírito Santo, Brazil

Chongqing, Chongqing, China

Kunming, Yunnan, China

Ivanic Grad, , Croatia

Krakow, , Poland

Houston, Texas, United States

Salvador, Bahia, Brazil

Santiago, , Chile

Napoli, , Italy

Tulsa, Oklahoma, United States

New York, New York, United States

Ribeirão Preto, São Paulo, Brazil

Sao Paulo, São Paulo, Brazil

Sosnowiec, , Poland

Thomasville, Georgia, United States

Osorno, , Chile

Chengdu, Sichuan, China

Wroclaw, , Poland

Cypress, Texas, United States

Shenzhen, , China

New York, New York, United States

Cypress, Texas, United States

Cluj Napoca, , Romania

Cullman, Alabama, United States

Bridgewater, New Jersey, United States

Morristown, Tennessee, United States

Bucharest, , Romania

Miami Lakes, Florida, United States

Newmarket, Ontario, Canada

Jiangyin, Jiangsu, China

Lubbock, Texas, United States

Providence, Utah, United States

Sao Paulo, São Paulo, Brazil

Santiago, , Chile

Beijing, Beijing, China

Ningbo, Zhejiang, China

Zagreb, , Croatia

Brest, , France

Nantes, , France

Jackson Heights, New York, United States

Fullerton, California, United States

San Diego, California, United States

Providence, Rhode Island, United States

Coral Springs, Florida, United States

Miami, Florida, United States

Coral Springs, Florida, United States

Southlake, Texas, United States

Lubbock, Texas, United States

Beijing, Beijing, China

Calgary, Alberta, Canada

Lublin, , Poland

Columbus, Georgia, United States

Bowling Green, Kentucky, United States

Lubbock, Texas, United States

Belo Horizonte, Minas Gerais, Brazil

Jau, São Paulo, Brazil

Hangzhou, Zhejiang, China

Bear Sheva, , Israel

Toluca, , Mexico

Katowice, , Poland

Guangzhou, Guangdong, China

Dalian, Liaoning, China

Hangzhou, Zhejiang, China

Patients applied

0 patients applied

Trial Officials

MD

Study Director

Amgen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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