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A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
Sponsor: Amgen
Summary
The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).
Official title: A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
469
Start Date
2024-07-18
Completion Date
2026-06-25
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
Rocatinlimab
SC Injection
Placebo
SC Injection
Locations (192)
University of Alabama at Birmingham
Birmingham, Alabama, United States
First OC Dermatology
Fountain Valley, California, United States
Los Angeles Universal Research Center
Los Angeles, California, United States
Paradigm Clinical Research Center Inc
San Diego, California, United States
Wolverine Clinical Trials
Santa Ana, California, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Southern Clinical Research
Miami, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Miami Dermatology and Laser Institute
Miami, Florida, United States
Wellness Clinical Research
Miami Lakes, Florida, United States
Clinical Research Trials of Florida Inc
Tampa, Florida, United States
Olympian Clinical Research - Tampa
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Endeavor Health Clinical Trials Center
Skokie, Illinois, United States
The Indiana Clinical Trials Center PC
Plainfield, Indiana, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Optima Research
Boardman, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Wright State Physicians
Fairborn, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Center For Clinical Studies PLLC
Houston, Texas, United States
Clarity Dermatology
Lancaster, Texas, United States
Springville Dermatology
Springville, Utah, United States
Hospital Universitario Austral
Derqui, Pilar, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas de Cordoba
Córdoba, Córdoba Province, Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, Distrito Federal, Argentina
Derma Internacional
Buenos Aires, Distrito Federal, Argentina
Centro de investigacion clinica y epidemiologica
San Miguel D Tucuman, Tucumán Province, Argentina
Parra Dermatologia
Mendoza, Argentina
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Medizinische Universitaet Graz
Graz, Austria
Ordensklinikum Linz Elisabethinen
Linz, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, Belgium
Universitaire Ziekenhuizen Leuven Gasthuisberg
Leuven, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, Belgium
Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
Salvador, Estado de Bahia, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Estadual Paulista Julio de Mesquita Filho
Botucatu, São Paulo, Brazil
Fundacao Abc - Centro Univ Fmabc
Santo André, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
IBPClin Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, Brazil
Doctor Chih-Ho Hong Medical Incorporated
Surrey, British Columbia, Canada
Skincare Studio
St. John's, Newfoundland and Labrador, Canada
CCA Medical Research Corp
Ajax, Ontario, Canada
Centricity Research London Victoria
London, Ontario, Canada
Lovegrove Dermatology
London, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada
Toronto Research Centre Inc
Toronto, Ontario, Canada
AvantDerm
Toronto, Ontario, Canada
Alliance Clinical Trials
Waterloo, Ontario, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, Canada
Enroll SpA
Providencia, Santiago Metropolitan, Chile
Centro Medico Skinmed Spa
Santiago, Chile
Fundacion Innovacion Cardiovascular Clinica Ensenada
Santiago, Chile
Centro Internacional de Estudios Clinicos
Santiago, Chile
Clinical Research Chile SpA
Valdivia, Chile
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital Sun-Yat Sen University
Guangzhou, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
The Second Affiliated Hospital Of Xi An Jiaotong University
Xi'an, Shaanxi, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Chengdu Second Peoples Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
Hangzhou, Zhejiang, China
Clinical Research Services Helsinki
Helsinki, Finland
Oulun Yliopistollinen sairaala
Oulu, Finland
Terveystalo Tampere
Tampere, Finland
Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
Brest, France
Centre Hospitalier Le Mans
Le Mans, France
Cabinet du Docteur Ruer-Mulard Mireille
Martigues, France
Centre Hospitalier Universitaire Archet 2
Nice, France
Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
Rouen, France
Universitaetsklinikum Augsburg
Augsburg, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Germany
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, Germany
Rosenpark Research GmbH
Darmstadt, Germany
Universitaetsklinikum Dresden
Dresden, Germany
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, Germany
Universitaetsmedizin Mainz
Mainz, Germany
Universitaetsklinikum Muenster
Münster, Germany
Hautarztpraxis Mortazawi
Remscheid, Germany