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TERMINATED
NCT06527404
PHASE3

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

Sponsor: Amgen

View on ClinicalTrials.gov

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

Interventions

DRUG

Rocatinlimab

SC Injection

DRUG

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

And 92 more locations on ClinicalTrials.gov