A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Launched by AMGEN · May 22, 2023
Trial Information
Current as of June 05, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called rocatinlimab to see how safe it is and how well it works for people aged 12 and older who have moderate to severe atopic dermatitis, which is a type of skin condition that causes itching and inflammation. The main goal is to find out if rocatinlimab remains safe and tolerable when used over a longer period. If you or someone you know has recently finished a related study involving rocatinlimab, you might be eligible to participate in this trial.
Participants will be monitored closely during the study to check for any side effects or issues and to see how their skin condition responds to the treatment. It's important to note that people who had to stop using rocatinlimab in previous studies for safety reasons cannot join this trial. If you qualify and decide to take part, you'll be contributing to valuable research that could help improve treatments for atopic dermatitis in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
- • Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
- Exclusion Criteria:
- • Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.
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
Ann Arbor, Michigan, United States
Tampa, Florida, United States
Charleston, South Carolina, United States
Norfolk, Virginia, United States
Liverpool, New South Wales, Australia
Bangkok, , Thailand
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Zaragoza, , Spain
Lausanne, , Switzerland
Pittsburgh, Pennsylvania, United States
Box Hill, Victoria, Australia
Los Angeles, California, United States
Detroit, Michigan, United States
Houston, Texas, United States
Singapore, , Singapore
Ann Arbor, Michigan, United States
Parkville, Victoria, Australia
New York, New York, United States
Barcelona, , Spain
Saint Louis, Missouri, United States
Melbourne, Victoria, Australia
London, , United Kingdom
Taipei, , Taiwan
Ioannina, , Greece
Madrid, , Spain
Ljubljana, , Slovenia
Tuebingen, , Germany
St Leonards, New South Wales, Australia
Troy, Michigan, United States
San Antonio, Texas, United States
Hot Springs, Arkansas, United States
Portland, Oregon, United States
Madrid, , Spain
Taipei, , Taiwan
Bellaire, Texas, United States
Bern, , Switzerland
Detroit, Michigan, United States
Bad Bentheim, , Germany
Heidelberg, , Germany
Seoul, , Korea, Republic Of
Itabashi Ku, Tokyo, Japan
Itabashi Ku, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Tainan, , Taiwan
Seoul, , Korea, Republic Of
Groningen, , Netherlands
Los Angeles, California, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Thessaloniki, , Greece
Bangkok, , Thailand
Benowa, Queensland, Australia
Hellerup, , Denmark
Almada, , Portugal
Santiago De Compostela, La Coruña, Spain
Rapid City, South Dakota, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Orange, California, United States
Nagoya Shi, Aichi, Japan
Fukushima Shi, Fukushima, Japan
Yokohama Shi, Kanagawa, Japan
Seoul, , Korea, Republic Of
North Bay, Ontario, Canada
Portland, Oregon, United States
Liverpool, , United Kingdom
Omaha, Nebraska, United States
London, , United Kingdom
Muenster, , Germany
Scottsdale, Arizona, United States
West Dundee, Illinois, United States
Indianapolis, Indiana, United States
Winnipeg, Manitoba, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Santiago, , Chile
Seoul, , Korea, Republic Of
Gdansk, , Poland
Dresden, , Germany
Quebec, , Canada
Santa Monica, California, United States
Graz, , Austria
Utrecht, , Netherlands
Salzburg, , Austria
Sevilla, , Spain
Skokie, Illinois, United States
Beijing, Beijing, China
Shenyang, Liaoning, China
London, , United Kingdom
Wuppertal, , Germany
Taipei, , Taiwan
Paris Cedex 10, , France
Pamplona, Navarra, Spain
Zagreb, , Croatia
Beijing, Beijing, China
Seoul, , Korea, Republic Of
New York, New York, United States
Normal, Illinois, United States
Changsha, Hunan, China
Winnipeg, Manitoba, Canada
Athens, , Greece
Barcelona, Cataluña, Spain
Incheon, , Korea, Republic Of
Kiel, , Germany
Seoul, , Korea, Republic Of
Torino, , Italy
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Chevy Chase, Maryland, United States
Shimotsuga Gun, Tochigi, Japan
Berlin, , Germany
Surrey, British Columbia, Canada
Singapore, , Singapore
Gent, Oost Vlaanderen, Belgium
Zuerich, , Switzerland
Seoul, , Korea, Republic Of
Wilmington, North Carolina, United States
Alpharetta, Georgia, United States
Ajax, Ontario, Canada
Kogarah, New South Wales, Australia
La Plata, Buenos Aires, Argentina
Madrid, , Spain
Shinagawa Ku, Tokyo, Japan
Changchun, Jilin, China
Kaohsiung, , Taiwan
Debrecen, , Hungary
Santiago De Compostela, La Coruna, Spain
Santiago De Compostela, Galicia, Spain
Wuhan, Hubei, China
Hong Kong, , Hong Kong
Milano, , Italy
Richmond Hill, Ontario, Canada
Reno, Nevada, United States
Shijiazhuang, Hebei, China
Larissa, , Greece
Wuhan, Hubei, China
Singapore, , Singapore
Porto Alegre, Rio Grande Do Sul, Brazil
Hamamatsu Shi, Shizuoka, Japan
Centennial, Colorado, United States
Seoul, , Korea, Republic Of
Sacramento, California, United States
Guangzhou, Guangdong, China
Saint John's, Newfoundland And Labrador, Canada
Gilly, , Belgium
Encinitas, California, United States
Manises, Comunidad Valenciana, Spain
Phoenix, Arizona, United States
Fukuoka Shi, Fukuoka, Japan
Inashiki Gun, Ibaraki, Japan
Setagaya Ku, Tokyo, Japan
Lisboa, , Portugal
San Antonio, Texas, United States
Kobe Shi, Hyogo, Japan
Kocaeli, , Turkey
Pleven, , Bulgaria
Porto Alegre, , Brazil
Wilmington, North Carolina, United States
Hialeah, Florida, United States
Gwangju, , Korea, Republic Of
Taipei, , Taiwan
Taoyuan, , Taiwan
Rozzano Mi, , Italy
Kogarah, New South Wales, Australia
Woolloongabba, Queensland, Australia
Taizhou, Zhejiang, China
Seoul, , Korea, Republic Of
Etobicoke, Ontario, Canada
Santiago, , Chile
Bruxelles, , Belgium
Kerrville, Texas, United States
Katowice, , Poland
Tallinn, , Estonia
Seoul, , Korea, Republic Of
Johor Bahru, Johor, Malaysia
Plzen, , Czechia
Seoul, , Korea, Republic Of
Pozuelo De Alarcon, Madrid, Spain
Tartu, , Estonia
Tampere, , Finland
Budapest, , Hungary
Budapest, , Hungary
Nagasaki Shi, Nagasaki, Japan
Gyongyos, , Hungary
Louisville, Kentucky, United States
Rennes Cedex 9, , France
Murray, Utah, United States
Hamilton, Ontario, Canada
Beijing, Beijing, China
Lancaster, California, United States
Las Vegas, Nevada, United States
Bronx, New York, United States
Bryant, Arkansas, United States
Liege, , Belgium
Gahanna, Ohio, United States
Perugia, , Italy
Roma, , Italy
Phoenix, Arizona, United States
Ioannina, , Greece
Lille, , France
Istanbul, , Turkey
Kyoto Shi, Kyoto, Japan
Seoul, , Korea, Republic Of
Oklahoma City, Oklahoma, United States
Towson, Maryland, United States
Fountain Valley, California, United States
Miami, Florida, United States
Charlotte, North Carolina, United States
Frankfurt Am Main, , Germany
Shanghai, Shanghai, China
Miami Lakes, Florida, United States
Yokohama Shi, Kanagawa, Japan
Hamamatsu Shi, Shizuoka, Japan
Veszprem, , Hungary
Yokohama Shi, Kanagawa, Japan
Neyagawa Shi, Osaka, Japan
Boise, Idaho, United States
Clarksville, Indiana, United States
Gahanna, Ohio, United States
Norfolk, Virginia, United States
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Nanchang, Jiangxi, China
Bergen Op Zoom, , Netherlands
Bexley, Ohio, United States
Tulsa, Oklahoma, United States
Porto Alegre, , Brazil
Kawasaki Shi, Kanagawa, Japan
Montreal, Quebec, Canada
Warszawa, , Poland
Wuppertal, , Germany
Sao Paulo, São Paulo, Brazil
São José Do Rio Preto, São Paulo, Brazil
Kawasaki Shi, Kanagawa, Japan
Seongnam Si, Gyeonggi Do, , Korea, Republic Of
Badalona, Cataluña, Spain
Sandy Springs, Georgia, United States
Flint, Michigan, United States
Chicago, Illinois, United States
Corpus Christi, Texas, United States
Martigues, , France
Alicante, Comunidad Valenciana, Spain
Centennial, Colorado, United States
Carlton, Victoria, Australia
Guelph, Ontario, Canada
North Little Rock, Arkansas, United States
Philadelphia, Pennsylvania, United States
Nagakute Shi, Aichi, Japan
Surrey, British Columbia, Canada
Markham, Ontario, Canada
Novy Jicin, , Czechia
Budapest, , Hungary
Obihiro Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Takaoka Shi, Toyama, Japan
Darmstadt, , Germany
Remscheid, , Germany
Dublin, California, United States
Caba, Buenos Aires, Argentina
Rio De Janeiro, , Brazil
Sofia, , Bulgaria
Ostrava, , Czechia
Praha 3, , Czechia
Chieti, , Italy
Suwon Si, Gyeonggi Do, , Korea, Republic Of
Cordoba, Andalucía, Spain
Shinjuku Ku, Tokyo, Japan
Newmarket, Ontario, Canada
Asahikawa Shi, Hokkaido, Japan
Morioka Shi, Iwate, Japan
Lille, , France
Hospitalet De Llobregat, Cataluña, Spain
Dupnitsa, , Bulgaria
Barrie, Ontario, Canada
Santa Ana, California, United States
Saskatoon, Saskatchewan, Canada
Guangzhou, Guangdong, China
Sagamihara Shi, Kanagawa, Japan
Kew Gardens, New York, United States
Praha 8, , Czechia
Fayetteville, Georgia, United States
Zalaegerszeg, , Hungary
Lodz, , Poland
Habikino Shi, Osaka, Japan
Adachi Ku, Tokyo, Japan
Toshima Ku, Tokyo, Japan
Ipoh, Perak, Malaysia
Kyoto Shi, Kyoto, Japan
Miami Gardens, Florida, United States
Burlington, Ontario, Canada
Birmingham, Alabama, United States
Oulu, , Finland
Lublin, , Poland
Warszawa, , Poland
Pittsburgh, Pennsylvania, United States
North Las Vegas, Nevada, United States
Rosario, Santa Fe, Argentina
Cape Coral, Florida, United States
Nonoichi Shi, Ishikawa, Japan
Izumiotsu Shi, Osaka, Japan
Minato Ku, Tokyo, Japan
Cincinnati, Ohio, United States
Calgary, Alberta, Canada
Niagara Falls, Ontario, Canada
Nice, , France
Kawasaki Shi, Kanagawa, Japan
Sakai Shi, Osaka, Japan
Valencia, Comunidad Valenciana, Spain
Fuzhou, Fujian, China
Canoga Park, California, United States
San Diego, California, United States
Pardubice, , Czechia
Memmingen, , Germany
Lincoln, Nebraska, United States
Usti Nad Labem, , Czechia
Malbork, , Poland
Seoul, , Korea, Republic Of
Camberwell, Victoria, Australia
New York, New York, United States
Coral Gables, Florida, United States
Las Vegas, Nevada, United States
Praha 10, , Czechia
Sacramento, California, United States
Dallas, Texas, United States
Spokane, Washington, United States
Plainfield, Indiana, United States
Tulsa, Oklahoma, United States
Brighton, Massachusetts, United States
South Brisbane, Queensland, Australia
Nagoya Shi, Aichi, Japan
Hamilton, Ontario, Canada
Marugame Shi, Kagawa, Japan
Mainz, , Germany
Washington, District Of Columbia, United States
Goettingen, , Germany
Shipley, , United Kingdom
Murray, Kentucky, United States
Troy, Michigan, United States
Salford, , United Kingdom
Sugarloaf, Pennsylvania, United States
Suining, Sichuan, China
Long Beach, California, United States
Mississauga, Ontario, Canada
Windsor, Ontario, Canada
Leawood, Kansas, United States
Medford, Oregon, United States
El Paso, Texas, United States
Austin, Texas, United States
Winston Salem, North Carolina, United States
Hermitage, Tennessee, United States
Lynchburg, Virginia, United States
Plano, Texas, United States
Kumamoto Shi, Kumamoto, Japan
Beijing, , China
Murray, Utah, United States
Fukuoka Shi, Fukuoka, Japan
Kagoshima Shi, Kagoshima, Japan
Kumamoto Shi, Kumamoto, Japan
Margate, Florida, United States
Palmetto Bay, Florida, United States
Cedar Park, Texas, United States
Oakville, 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
Bakersfield, California, United States
Waterloo, Ontario, Canada
Nagoya Shi, Aichi, Japan
Shinjuku Ku, Tokyo, Japan
Nagoya Shi, Aichi, Japan
Doral, Florida, United States
Miami, Florida, United States
Lee's Summit, Missouri, United States
Dallas, Texas, United States
The Woodlands, Texas, United States
Richmond Hill, Ontario, Canada
Mesquite, Texas, United States
Albuquerque, New Mexico, United States
Ankara, , Turkey
Sacramento, California, United States
North York, Ontario, Canada
Nachod, , Czechia
Coburg, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Fukuoka Shi, Fukuoka, Japan
Szolnok, , Hungary
Boca Raton, Florida, United States
Lublin, , Poland
Tarnow, , Poland
Ciudad Autonoma De Buenos Aires, Distrito Federal, Argentina
Athens, , Greece
Riga, , Latvia
Talsi, , Latvia
Bratislava, , Slovakia
Topolcany, , Slovakia
Dallas, Texas, United States
Praha 5, , Czechia
Praha 6, , Czechia
Svitavy, , Czechia
Leipzig, , Germany
Porto, , Portugal
London, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Bekescsaba, , Hungary
Chorzow, , Poland
Katowice, , Poland
Bilbao, País Vasco, Spain
Hangzhou, Zhejiang, China
Kaposvar, , Hungary
Sugarloaf, Pennsylvania, United States
Caba, Distrito Federal, Argentina
Svidnik, , Slovakia
Akashi Shi, Hyogo, Japan
Oroshaza, , Hungary
Obihiro Shi, Hokkaido, Japan
Windsor, Ontario, Canada
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aires, Distrito Federal, Argentina
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Riga, , Latvia
Ciudad Autonoma De Buenos Aires, Distrito Federal, Argentina
Nea Ionia, , Greece
Lodz, , Poland
Doral, Florida, United States
Rosario, Santa Fe, Argentina
Gyongyos, , Hungary
Herstal, , Belgium
Maldegem, , Belgium
Warszawa, , Poland
Ciudad Autonoma De Buenos Aires, Distrito Federal, Argentina
Merzing, , Germany
Bratislava, , Slovakia
Miami, Florida, United States
Ciudad Autonoma De Buenos Aires, Distrito Federal, Argentina
Coimbra, , Portugal
Montreal, Quebec, Canada
Piraeus, , Greece
Winston Salem, North Carolina, United States
Hannover, , Germany
Georgetown, Pinang, Malaysia
Sao Bernardo Do Campo, São Paulo, Brazil
Antony, , France
Maribor, , Slovenia
Derqui, Pilar, Buenos Aires, Argentina
Ivanic Grad, , Croatia
Blankenfelde Mahlow, , Germany
Bochum, , Germany
Stuttgart, , Germany
Nowa Sol, , Poland
Las Palmas De Gran Canaria, Canarias, Spain
West Lafayette, Indiana, United States
Morelia, Michoacán, Mexico
Rouen Cedex, , France
Krakow, , Poland
Lodz, , Poland
Warszawa, , Poland
Cluj Napoca, , Romania
Medford, Oregon, United States
Berlin, , Germany
Gdansk, , Poland
Ottawa, Ontario, Canada
Doral, Florida, United States
Miami, Florida, United States
Richmond Hill, Ontario, Canada
Toronto, Ontario, Canada
Kutna Hora, , Czechia
Izmir, , Turkey
Lorient Cedex, , France
Lancaster, California, United States
New Albany, Indiana, United States
Nanyang, Henan, China
Leawood, Kansas, United States
Poznan, , Poland
Dallas, Texas, United States
Praha, , Czechia
Hamburg, , Germany
Los Angeles, California, United States
San Francisco, California, United States
Leawood, Kansas, United States
Hangzhou, Zhejiang, China
Brooklyn, New York, United States
San Francisco, California, United States
Kortrijk, , Belgium
Wroclaw, , Poland
Scottsdale, Arizona, United States
Northridge, California, United States
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Toronto, Ontario, Canada
Bialystok, , Poland
Warszawa, , Poland
Szczecin, , Poland
Rosario, Santa Fe, Argentina
Osnabrueck, , Germany
Mayfield Heights, Ohio, United States
Vitória, Espírito Santo, Brazil
Chongqing, Chongqing, China
Kunming, Yunnan, China
Muenchen, , Germany
Springfield, Ohio, United States
Portland, Oregon, United States
Shinjuku Ku, Tokyo, Japan
Krakow, , Poland
Clayton, Victoria, Australia
Lodz, , Poland
Wuxi, Jiangsu, China
Las Vegas, Nevada, United States
Banska Bystrica, , Slovakia
Kayseri, , Turkey
Samsun, , Turkey
Long Beach, California, United States
Hangzhou, Zhejiang, China
Gaziantep, , Turkey
Salvador, Bahia, Brazil
Santiago, , Chile
Napoli, , Italy
Pasadena, California, United States
Homestead, Florida, United States
Loverval, , Belgium
Sofia, , Bulgaria
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Laquila, , Italy
Bardejov, , Slovakia
Istanbul, , Turkey
Istanbul, , Turkey
Tulsa, Oklahoma, United States
La Plata, , Argentina
Mitcham, Victoria, Australia
Curitiba, Paraná, Brazil
Edmonton, Alberta, Canada
Sao Paulo, São Paulo, Brazil
Sosnowiec, , Poland
Tampa, Florida, United States
Sanmenxia, Henan, China
Osorno, , Chile
Praha 3, , Czechia
Wroclaw, , Poland
Edmonton, Alberta, Canada
Newmarket, Ontario, Canada
Quebec City, Quebec, Canada
Wuxi, Jiangsu, China
São José Dos Campos, São Paulo, Brazil
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Santo Andre, São Paulo, Brazil
Ciudad Autonoma De Buenos Aires, Distrito Federal, Argentina
Winnipeg, Manitoba, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Shantou, Guangdong, China
Ningbo, Zhejiang, China
Wilmington, North Carolina, United States
Caba, Distrito Federal, Argentina
Sorocaba, São Paulo, Brazil
Quebec, , Canada
Pardubice, , Czechia
Westville, Durban, Kwazulu Natal, South Africa
Beijing, Beijing, China
Ningbo, Zhejiang, China
Zagreb, , Croatia
Brest, , France
Curitiba, Paraná, Brazil
Bezannes, , France
Toronto, Ontario, Canada
Porto, , Portugal
Porto, , Portugal
Tustin, California, United States
Homestead, Florida, United States
Helsinki, , Finland
Berlin, , Germany
Cuautitlán Izcalli, , Mexico
Almada, , Portugal
Coimbra, , Portugal
London, Ontario, Canada
Coral Springs, Florida, United States
Miami, Florida, United States
Coral Springs, Florida, United States
Lublin, , Poland
Richmond Hill, Ontario, Canada
Hangzhou, Zhejiang, China
Camp Hill, Pennsylvania, United States
Southlake, Texas, United States
Praha 6, , Czechia
Berlin, , Germany
Leipzig, , Germany
Bucheon Si, Gyeonggi Do, , Korea, Republic Of
Houston, Texas, United States
Caba, Buenos Aires, Argentina
Guangzhou, Guangdong, China
Hangzhou, Zhejiang, China
Lisboa, , Portugal
Charlotte, North Carolina, United States
Ajax, Ontario, Canada
Mahlow, , Germany
Hong Kong, , Hong Kong
Sao Bernardo Do Campo, São Paulo, Brazil
Coburg, Ontario, Canada
Ottawa, Ontario, Canada
Caba, Distrito Federal, Argentina
Sao Bernardo Do Campo, São Paulo, Brazil
Rouen, , France
Detroit, Michigan, United States
Gilly, , Belgium
Camp Hill, Pennsylvania, United States
Caba, Distrito Federal, Argentina
Charleroi, , Belgium
Barueri, São Paulo, Brazil
Forest, Virginia, United States
Poznan, , Poland
Chevy Chase, Maryland, United States
Camberwell, Victoria, Australia
Brest, , France
Vitoria, Espírito Santo, Brazil
Rouen, , France
Caba, Buenos Aires, Argentina
São José Dos Campos, São Paulo, Brazil
Changsha, Hunan, China
Skokie, Illinois, United States
Yokohama Shi, Kanagawa, Japan
Shinagawa Ku, Tokyo, Japan
Niagara Falls, Ontario, Canada
Shenzhen, Guangdong, China
Tarnow, , Poland
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported