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 27, 2025
Active, not recruiting
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Barcelona, , Spain
Gdansk, , Poland
Dresden, , Germany
Santa Monica, California, United States
Erlangen, , Germany
Bellevue, Washington, United States
Esplugues De Llobregat, , Spain
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
São José Do Rio Preto, , Brazil
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
Vitória, , Brazil
Jau, , Brazil
Ribeirão Preto, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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