A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Launched by AMGEN · Dec 7, 2022
Trial Information
Current as of June 04, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
- • History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency (with or without topical calcineurin inhibitors \[TCI\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
- • EASI score ≥16
- • vIGA-AD score ≥3
- • ≥10% body surface area (BSA) of AD involvement
- • Worst pruritus numerical rating scale ≥ 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:
- • Systemic corticosteroids
- • Systemic immunosuppressants
- • Phototherapy
- • Oral or topical Janus kinase inhibitors
- * Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- • TCS of any potency
- • TCI
- • Topical phosphodiesterase type 4 (PDE4) inhibitors
- • Other topical immunosuppressive agents
- • Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other 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
Bronx, New York, United States
Norfolk, Virginia, United States
Madrid, , Spain
Box Hill, Victoria, Australia
Houston, Texas, United States
Salt Lake City, Utah, United States
Cincinnati, Ohio, United States
Lebanon, New Hampshire, United States
Parkville, Victoria, Australia
New York, New York, United States
Melbourne, Victoria, Australia
London, , United Kingdom
Troy, Michigan, United States
San Antonio, Texas, United States
Hot Springs, Arkansas, United States
Southampton, , United Kingdom
Portland, Oregon, United States
Bruxelles, , Belgium
Madrid, , Spain
Odense, , Denmark
Bellaire, Texas, United States
Bad Bentheim, , Germany
Sevilla, , Spain
Shinagawa Ku, Tokyo, Japan
Seoul, , Korea, Republic Of
Hellerup, , Denmark
Almada, , Portugal
Stockholm, , Sweden
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Yokohama Shi, Kanagawa, Japan
Seoul, , Korea, Republic Of
Bucharest, , Romania
Seoul, , Korea, Republic Of
Muenster, , Germany
Peterborough, Ontario, Canada
Seoul, , Korea, Republic Of
Gdansk, , Poland
Gaziantep, , Turkey
Quebec, , Canada
Santa Monica, California, United States
Wuppertal, , Germany
Pamplona, Navarra, Spain
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Normal, Illinois, United States
Incheon, , Korea, Republic Of
Kiel, , Germany
Seoul, , Korea, Republic Of
Majadahonda, , Spain
Kogarah, New South Wales, Australia
Miami, Florida, United States
Richmond Hill, Ontario, Canada
Reno, Nevada, United States
Busan, , Korea, Republic Of
East Melbourne, Victoria, Australia
Hamamatsu Shi, Shizuoka, Japan
Seoul, , Korea, Republic Of
Markham, Ontario, Canada
Encinitas, California, United States
Manises, Comunidad Valenciana, Spain
Lisboa, , Portugal
San Antonio, Texas, United States
Kobe Shi, Hyogo, Japan
Kocaeli, , Turkey
Hamburg, , Germany
Kocaeli, , Turkey
Hialeah, Florida, United States
Gwangju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Etobicoke, Ontario, Canada
Tallinn, , Estonia
Plzen, , Czechia
Seoul, , Korea, Republic Of
Tartu, , Estonia
Tampere, , Finland
Nagasaki Shi, Nagasaki, Japan
Louisville, Kentucky, United States
Berlin, , Germany
Murray, Utah, United States
Corby, , United Kingdom
Kew Gardens, New York, United States
Gahanna, Ohio, United States
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Sevilla, Andalucía, Spain
Kawasaki Shi, Kanagawa, Japan
Seongnam Si, Gyeonggi Do, , Korea, Republic Of
Sandy Springs, Georgia, United States
Omaha, Nebraska, United States
Alicante, Comunidad Valenciana, Spain
Carlton, Victoria, Australia
Surrey, British Columbia, Canada
Markham, Ontario, Canada
Novy Jicin, , Czechia
Takaoka Shi, Toyama, Japan
South Bend, Indiana, United States
Remscheid, , Germany
Scottsdale, Arizona, United States
Dublin, California, United States
Praha 3, , Czechia
Suwon Si, Gyeonggi Do, , Korea, Republic Of
Chihuahua, , Mexico
Shinjuku Ku, Tokyo, Japan
Sagamihara Shi, Kanagawa, Japan
Kew Gardens, New York, United States
Lodz, , Poland
São José Dos Campos, São Paulo, Brazil
Habikino Shi, Osaka, Japan
Toshima Ku, Tokyo, Japan
Palmdale, California, United States
West Lafayette, Indiana, United States
Litchfield Park, Arizona, United States
Riverdale, New Jersey, United States
North Hollywood, California, United States
Cape Coral, Florida, United States
Horseheads, New York, United States
Minato Ku, Tokyo, Japan
Overland Park, Kansas, United States
Cincinnati, Ohio, United States
Sakai Shi, Osaka, Japan
Poznan, , Poland
Valencia, Comunidad Valenciana, Spain
La Mesa, California, United States
Pardubice, , Czechia
Seoul, , Korea, Republic Of
New York, New York, United States
Coral Gables, Florida, United States
Denver, Colorado, United States
Spokane, Washington, United States
Brighton, Massachusetts, United States
Washington, District Of Columbia, United States
Doral, Florida, United States
Murray, Kentucky, United States
Troy, Michigan, United States
Warwick, Rhode Island, United States
Castle Rock, Colorado, United States
Windsor, Ontario, Canada
Chula Vista, California, United States
Fremont, California, United States
Margate, Florida, United States
Palmetto Bay, Florida, United States
Normal, Illinois, United States
Farmington Hills, Michigan, United States
Las Vegas, Nevada, United States
New York, New York, United States
Grants Pass, Oregon, United States
Cedar Park, Texas, United States
Oakville, Ontario, Canada
Toronto, Ontario, Canada
Matsudo Shi, Chiba, Japan
Narita Shi, Chiba, Japan
Ansansi, Gyeonggido, , Korea, Republic Of
Bucheon Si, Gyeonggi Do, , Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Doral, Florida, United States
Las Vegas, Nevada, United States
Lewisville, Texas, United States
Darlinghurst, New South Wales, Australia
Monroe, New York, United States
Kunta Hora, , Czechia
Rogers, Arkansas, United States
Las Vegas, Nevada, United States
Lublin, , Poland
Dallas, Texas, United States
Praha 5, , Czechia
Praha 6, , Czechia
Praha, , Czechia
Svitavy, , Czechia
Leipzig, , Germany
Muenster, , Germany
Osnabrück, , Germany
Porto, , Portugal
Chorzow, , Poland
Fayetteville, Arkansas, United States
Berlin, , Germany
Windsor, Ontario, Canada
Doral, Florida, United States
San Francisco, California, United States
Herstal, , Belgium
Maldegem, , Belgium
Sherbrooke, Quebec, Canada
Halle (Saale), , Germany
Porto, , Portugal
Ankara, , Turkey
Istanbul, , Turkey
Kayseri, , Turkey
Coimbra, , Portugal
Chula Vista, California, United States
Sao Bernardo Do Campo, São Paulo, Brazil
Cuautitlán Izcalli, , Mexico
Istanbul, , Turkey
West Lafayette, Indiana, United States
Curitiba, Paraná, Brazil
Berlin, , Germany
Morelia, Michoacán, Mexico
Lodz, , Poland
Berlin, , Germany
Kutna Hora, , Czechia
Johannesburg, Gauteng, South Africa
Durban, , South Africa
Izmir, , Turkey
Sakarya, , Turkey
San Antonio, Texas, United States
Durham, North Carolina, United States
Lampasas, Texas, United States
Tampa, Florida, United States
New York, New York, United States
Dallas, Texas, United States
Praha, , Czechia
Centurion, Gauteng, South Africa
Helsinki, , Finland
Helsinki, , Finland
Oulu, , Finland
Bialystok, , Poland
Krakow, , Poland
Warszawa, , Poland
Missouri City, Texas, United States
Osnabrueck, , Germany
Houston, Texas, United States
Lodz, , Poland
Kayseri, , Turkey
Istanbul, , Turkey
Houston, Texas, United States
Gaziantep, , Turkey
Sakarya, , Turkey
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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