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Search / Trial NCT05882877

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

Atopic Dermatitis Rocatinlimab Amg 451 Eczema

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.

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

0 patients applied

Trial Officials

MD

Study Director

Amgen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported