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ACTIVE NOT RECRUITING
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

2027-01-17

Last Updated

2026-01-20

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

Universitaetsklinikum Tuebingen

Tübingen, Germany

Helios Klinikum Wuppertal

Wuppertal, Germany

University General Hospital Attikon

Athens, Greece

Andreas Syngros Hospital Of Venereal And Dermatological Diseases

Athens, Greece

General Hospital Of Nea Ionia Konstantopouleio Patision

Nea Ionia, Greece

Ippokratio General Hospital of Thessaloniki

Thessaloniki, Greece

Papageorgiou General Hospital

Thessaloniki, Greece

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Obudai Egeszsegugyi Centrum Kft

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Derm-Surg Kft

Kaposvár, Hungary

DermaMed Research Kft

Orosháza, Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

Szeged, Hungary

Ospedale San Salvatore

LAquila, Italy

Azienda Ospedaliera Luigi Sacco

Milan, Italy

Azienda Ospedaliero Universitaria di Modena

Modena, Italy

Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

Perugia, Italy

Fondazione Policlinico Tor Vergata

Roma, Italy

Fujita Health University Hospital

Toyoake-shi, Aichi-ken, Japan

Ogaki Municipal Hospital

Ogaki-shi, Gifu, Japan

Medical Corporation Kojinkai Sapporo Skin Clinic

Sapporo, Hokkaido, Japan

Mito Kyodo General Hospital

Mito, Ibaraki, Japan

Kochi Medical School Hospital

Nankoku-shi, Kochi, Japan

Noguchi Dermatology Clinic

Kamimashiki-gun, Kumamoto, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

Kawasaki Medical School Hospital

Kurashiki-shi, Okayama-ken, Japan

Hayami Dermatology Clinic

Osaka, Osaka, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya-shi, Saitama, Japan

National Defense Medical College hospital

Tokorozawa-shi, Saitama, Japan

Institute of Science Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Tokyo Teishin Hospital

Chiyoda-ku, Tokyo, Japan

Shirasaki Dermatology Clinic

Takaoka-shi, Toyama, Japan

Tokyo Medical University Hospital

Shinjyuku-ku, Japan

J Kisis

Riga, Latvia

Outpatient clinic Veselibas Centrs 4

Riga, Latvia

Outpatient clinic Veselibascentrs 4

Riga, Latvia

Clínica de Enfermedades Crónicas y de Procedimientos Especiales

Morelia, Michoacán, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A C

Durango, Mexico

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Niepubliczny Zaklad Opieki Zdrowotnej

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy

Gdansk, Poland

GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero

Katowice, Poland

Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne

Lodz, Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Poland

Uniwersytecki Szpital Kliniczny imienia Fryderyka Chopina w Rzeszowie

Rzeszów, Poland

Velocity Skierniewice Spolka z Ograniczona Odpowiedzialnoscia

Skierniewice, Poland

Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych

Sosnowiec, Poland

Royalderm Agnieszka Nawrocka

Warsaw, Poland

Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spolka Partnerska

Wroclaw, Poland

DermMedica Spzoo Centrum Columbus

Wroclaw, Poland

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, Portugal

Hospital Cuf Descobertas

Lisbon, Portugal

Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio

Porto, Portugal

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, Romania

Spitalul Clinic Judetean Mures

Târgu Mureş, Romania

Korea University Ansan Hospital

Ansansi, Gyeonggido, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Canary Islands, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Hospital General Universitario de Alicante

Alicante, Valencia, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Diagnostiskt Centrum Hud i Sickla

Nacka, Sweden

Akademiska sjukhuset

Uppsala, Sweden

Inselspital Bern

Bern, Switzerland

Universitaetsspital Zuerich

Zuerich Flughafen, Switzerland

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Mackay Memorial Hospital Taipei Branch

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

Adnan Menderes Universitesi Medical Faculty

Aydin, Turkey (Türkiye)

Pamukkale Universitesi Tip Fakultesi Hastanesi

Denizli, Turkey (Türkiye)

Gaziantep Universitesi Tip Fakultesi Hastanesi

Gaziantep, Turkey (Türkiye)

Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi

Izmir, Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, Turkey (Türkiye)

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Chapel Allerton Hospital

Leeds, United Kingdom

Royal London Hospital

London, United Kingdom

Guys Hospital

London, United Kingdom

Ameli-Biogroup Limited

Waltham Abbey, United Kingdom