A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
Launched by AMGEN · Jul 25, 2024
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called rocatinlimab for people with prurigo nodularis, a skin condition that causes severe itching and bumps. The goal is to see if rocatinlimab is more effective than a placebo (a treatment that does not contain any active medication) in reducing itchiness and improving overall skin condition after 24 weeks. The trial is currently looking for participants who are at least 18 years old, have been diagnosed with prurigo nodularis for at least three months, and have a significant amount of nodules on their skin.
To be eligible, participants should have tried other topical treatments without success or cannot use them due to side effects. During the trial, participants will be closely monitored and will need to report their daily itch levels using an electronic diary. It’s important to note that individuals with certain skin conditions or those who have recently received specific treatments may not qualify. This study aims to provide valuable information about a potential new option for managing this challenging condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years)
- • Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months.
- • Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to and including day 1.
- • Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk.
- • History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
- Exclusion Criteria:
- • Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed).
- • Prurigo nodularis secondary to medications.
- • Prurigo nodularis secondary to neurologic or psychiatric medical conditions.
- • Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization.
- • Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.
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
Badalona, , Spain
Box Hill, Victoria, Australia
Atlanta, Georgia, United States
Birmingham, Alabama, United States
Parkville, Victoria, Australia
Melbourne, Victoria, Australia
London, , United Kingdom
Taipei, , Taiwan
Madrid, , Spain
Uppsala, , Sweden
Tuebingen, , Germany
Cordoba, , Spain
Bern, , Switzerland
Bad Bentheim, , Germany
Thessaloniki, , Greece
Beijing, Beijing, China
Seoul, , Korea, Republic Of
Ogaki Shi, Gifu, Japan
Leeds, , United Kingdom
Muenster, , Germany
Peterborough, Ontario, Canada
Toronto, Ontario, Canada
Santiago, , Chile
Barcelona, , Spain
Gdansk, , Poland
Zaragoza, , Spain
Dresden, , Germany
Quebec, , Canada
Cleveland, Ohio, United States
Graz, , Austria
Utrecht, , Netherlands
Skokie, Illinois, United States
Nanning, Guangxi, China
Wuppertal, , Germany
Taipei, , Taiwan
Beijing, Beijing, China
Changsha, Hunan, China
Athens, , Greece
Le Mans Cedex 9, , France
Kiel, , Germany
Seoul, , Korea, Republic Of
Zuerich, , Switzerland
Milano, , Italy
Changchun, Jilin, China
Kaohsiung, , Taiwan
Debrecen, , Hungary
Shanghai, Shanghai, China
Chiyoda Ku, Tokyo, Japan
Hong Kong, , Hong Kong
Linz, , Austria
Nankoku Shi, Kochi, Japan
Seoul, , Korea, Republic Of
Guangzhou, Guangdong, China
Lisboa, , Portugal
Pecs, , Hungary
Szeged, , Hungary
Zuerich Flughafen, , Switzerland
Hialeah, Florida, United States
Taipei, , Taiwan
Taoyuan, , Taiwan
Shinjyuku Ku, , Japan
Kogarah, New South Wales, Australia
Woolloongabba, Queensland, Australia
Seoul, , Korea, Republic Of
Miami, Florida, United States
Bruxelles, , Belgium
London, , United Kingdom
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Tampere, , Finland
Budapest, , Hungary
Miami, Florida, United States
Nagasaki Shi, Nagasaki, Japan
Roma, , Italy
New York, New York, United States
Liege, , Belgium
Perugia, , Italy
Fairborn, Ohio, United States
Fountain Valley, California, United States
Shanghai, Shanghai, China
Modena, , Italy
Ostrowiec Swietokrzyski, , Poland
Troy, Michigan, United States
Nanchang, Jiangxi, China
Kamimashiki Gun, Kumamoto, Japan
Oklahoma City, Oklahoma, United States
Xi An, Shaanxi, China
Miami Lakes, Florida, United States
Barcelona, Cataluña, Spain
Warszawa, , Poland
Badalona, Cataluña, Spain
Martigues, , France
Alicante, Comunidad Valenciana, Spain
Valdivia, , Chile
Surrey, British Columbia, Canada
Markham, Ontario, Canada
Sapporo Shi, Hokkaido, Japan
Takaoka Shi, Toyama, Japan
Riga, , Latvia
Darmstadt, , Germany
Remscheid, , Germany
Cordoba, Andalucía, Spain
Oklahoma City, Oklahoma, United States
Guangzhou, Guangdong, China
Koshigaya Shi, Saitama, Japan
Tokorozawa Shi, Saitama, Japan
Toyoake Shi, Aichi, Japan
Tianjin, Tianjin, China
Oulu, , Finland
Providencia, Santiago, Chile
Miami, Florida, United States
Nice, , France
Fuzhou, Fujian, China
Springville, Utah, United States
Mito Shi, Ibaraki, Japan
Plainfield, Indiana, United States
Augsburg, , Germany
Cordoba, Córdoba, Argentina
Mainz, , Germany
Boardman, Ohio, United States
Ansansi, Gyeonggido, , Korea, Republic Of
Waterloo, Ontario, Canada
Ankara, , Turkey
Toronto, Ontario, Canada
Ciudad Autonoma De Buenos Aires, Distrito Federal, Argentina
Athens, , Greece
Riga, , Latvia
Katowice, , Poland
Oroshaza, , Hungary
Riga, , Latvia
Nea Ionia, , Greece
Targu Mures, , Romania
Derqui, Pilar, Buenos Aires, Argentina
Las Palmas De Gran Canaria, Canarias, Spain
Lodz, , Poland
Gdansk, , Poland
Thessaloniki, , Greece
Wroclaw, , Poland
Leuven, , Belgium
Samsun, , Turkey
Gaziantep, , Turkey
Salvador, Bahia, Brazil
Santiago, , Chile
Laquila, , Italy
Sosnowiec, , Poland
Tampa, Florida, United States
Sanmenxia, Henan, China
Chengdu, Sichuan, China
San Diego, California, United States
Brest, , France
London, Ontario, Canada
Lisboa, , Portugal
Porto, , Portugal
Tustin, California, United States
Helsinki, , Finland
London, Ontario, Canada
Tampa, Florida, United States
Richmond Hill, Ontario, Canada
Rouen Cedex, , France
Madrid, Fuencarral El Pardo, Spain
Los Angeles, California, United States
Houston, Texas, United States
Lancaster, Texas, United States
Guangzhou, Guangdong, China
Hangzhou, Zhejiang, China
Aydin, , Turkey
Bunkyo Ku, Tokyo, Japan
Ajax, Ontario, Canada
Denizli, , Turkey
Hong Kong, , Hong Kong
London, Ontario, Canada
Izmir, , Turkey
Kaposvar, , Hungary
Bialystok, , Poland
Osaka Shi, Osaka, Japan
Nacka, , Sweden
Cluj Napoca, , Romania
Waltham Abbey, , United Kingdom
Brest, , France
Santiago, , Chile
Berlin, , Germany
Rzeszow, , Poland
Wroclaw, , Poland
London, , United Kingdom
Skokie, Illinois, United States
Kunming, Yunnan, China
Wuxi, Jiangsu, China
San Miguel D Tucuman, Tucuman, Argentina
Ciudad Autonoma De Buenos Aires, Distrito Federal, Argentina
Mendoza, , Argentina
Cordoba, , Argentina
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported