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
Status: Recruiting
Location: See all (192) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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).
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
First OC Dermatology
RECRUITING
Fountain Valley
Los Angeles Universal Research Center
RECRUITING
Los Angeles
Paradigm Clinical Research Center Inc
RECRUITING
San Diego
Wolverine Clinical Trials
RECRUITING
Santa Ana
Florida
Direct Helpers Research Center
RECRUITING
Hialeah
Miami Dermatology and Laser Institute
RECRUITING
Miami
Southern Clinical Research
RECRUITING
Miami
University of Miami Hospital
RECRUITING
Miami
Wellness Clinical Research
RECRUITING
Miami Lakes
Clinical Research Trials of Florida Inc
RECRUITING
Tampa
Olympian Clinical Research - Tampa
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Endeavor Health Clinical Trials Center
RECRUITING
Skokie
Indiana
The Indiana Clinical Trials Center PC
RECRUITING
Plainfield
Michigan
Revival Research Institute, LLC
RECRUITING
Troy
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
Optima Research
RECRUITING
Boardman
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Wright State Physicians
RECRUITING
Fairborn
Oklahoma
Hightower Clinical
RECRUITING
Oklahoma City
Texas
Center For Clinical Studies PLLC
RECRUITING
Houston
Clarity Dermatology
RECRUITING
Lancaster
Utah
Springville Dermatology
RECRUITING
Springville
Other Locations
Argentina
Derma Internacional
RECRUITING
Buenos Aires
Instituto de Neumonologia y Dermatologia
RECRUITING
Buenos Aires
Instituto de Investigaciones Clinicas de Cordoba
RECRUITING
Córdoba
Hospital Universitario Austral
RECRUITING
Derqui, Pilar
Parra Dermatologia
RECRUITING
Mendoza
Centro de investigacion clinica y epidemiologica
RECRUITING
San Miguel D Tucuman
Australia
Box Hill Hospital
RECRUITING
Box Hill
St George Dermatology and Skin Cancer Centre
RECRUITING
Kogarah
The Alfred Hospital
RECRUITING
Melbourne
The Royal Melbourne Hospital
RECRUITING
Parkville
Veracity Clinical Research
RECRUITING
Woolloongabba
Austria
Medizinische Universitaet Graz
RECRUITING
Graz
Ordensklinikum Linz Elisabethinen
RECRUITING
Linz
Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
RECRUITING
Brussels
Universitaire Ziekenhuizen Leuven Gasthuisberg
RECRUITING
Leuven
Centre Hospitalier Universitaire de Liege - Sart Tilman
RECRUITING
Liège
Brazil
Universidade Estadual Paulista Julio de Mesquita Filho
RECRUITING
Botucatu
Irmandade da Santa Casa de Misericordia de Porto Alegre
RECRUITING
Porto Alegre
IBPClin Instituto Brasil de Pesquisa Clinica
RECRUITING
Rio De Janeiro
Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
RECRUITING
Salvador
Fundacao Abc - Centro Univ Fmabc
RECRUITING
Santo André
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
RECRUITING
São Paulo
Canada
CCA Medical Research Corp
RECRUITING
Ajax
Centricity Research London Victoria
RECRUITING
London
Lovegrove Dermatology
RECRUITING
London
Lynderm Research Inc
RECRUITING
Markham
SKiN Centre for Dermatology
RECRUITING
Peterborough
Centre de Recherche Dermatologique du Quebec Metropolitain
RECRUITING
Québec
York Dermatology Clinic and Research Centre
RECRUITING
Richmond Hill
Skincare Studio
RECRUITING
St. John's
Doctor Chih-Ho Hong Medical Incorporated
RECRUITING
Surrey
AvantDerm
RECRUITING
Toronto
Toronto Research Centre Inc
RECRUITING
Toronto
Alliance Clinical Trials
RECRUITING
Waterloo
Chile
Enroll SpA
RECRUITING
Providencia
Centro Internacional de Estudios Clinicos
RECRUITING
Santiago
Centro Medico Skinmed Spa
RECRUITING
Santiago
Fundacion Innovacion Cardiovascular Clinica Ensenada
RECRUITING
Santiago
Clinical Research Chile SpA
RECRUITING
Valdivia
China
Peking University First Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Chengdu Second Peoples Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Dermatology Hospital of Southern Medical University
RECRUITING
Guangzhou
Nanfang Hospital Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital Sun-Yat Sen University
RECRUITING
Guangzhou
Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
RECRUITING
Hangzhou
The Second Affliated Hospital of Kunming Medical University
RECRUITING
Kunming
Dermatology Hospital of Jiangxi Province
RECRUITING
Nanchang
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Sanmenxia Central Hospital
RECRUITING
Sanmenxia
Huashan Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Shanghai Skin Disease Hospital
RECRUITING
Shanghai
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Wuxi Peoples Hospital
RECRUITING
Wuxi
The Second Affiliated Hospital Of Xi An Jiaotong University
RECRUITING
Xi'an
Finland
Clinical Research Services Helsinki
RECRUITING
Helsinki
Oulun Yliopistollinen sairaala
RECRUITING
Oulu
Terveystalo Tampere
RECRUITING
Tampere
France
Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
RECRUITING
Brest
Centre Hospitalier Le Mans
RECRUITING
Le Mans
Cabinet du Docteur Ruer-Mulard Mireille
RECRUITING
Martigues
Centre Hospitalier Universitaire Archet 2
RECRUITING
Nice
Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
RECRUITING
Rouen
Germany
Universitaetsklinikum Augsburg
RECRUITING
Augsburg
Fachklinik Bad Bentheim
RECRUITING
Bad Bentheim
Charite - Universitaetsmedizin Berlin, Campus Virchow
RECRUITING
Berlin
Rosenpark Research GmbH
RECRUITING
Darmstadt
Universitaetsklinikum Dresden
RECRUITING
Dresden
Universitaetsklinikum Schleswig-Holstein - Kiel
RECRUITING
Kiel
Universitaetsmedizin Mainz
RECRUITING
Mainz
Universitaetsklinikum Muenster
RECRUITING
Münster
Hautarztpraxis Mortazawi
RECRUITING
Remscheid
Universitaetsklinikum Tuebingen
RECRUITING
Tübingen
Helios Klinikum Wuppertal
RECRUITING
Wuppertal
Greece
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
RECRUITING
Athens
University General Hospital Attikon
RECRUITING
Athens
General Hospital Of Nea Ionia Konstantopouleio Patision
RECRUITING
Nea Ionia
Ippokratio General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Papageorgiou General Hospital
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital, The University of Hong Kong
RECRUITING
Hong Kong
Hungary
Obudai Egeszsegugyi Centrum Kft
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Derm-Surg Kft
RECRUITING
Kaposvár
DermaMed Research Kft
RECRUITING
Orosháza
Pecsi Tudomanyegyetem Klinikai Kozpont
RECRUITING
Pécs
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
RECRUITING
Szeged
Italy
Ospedale San Salvatore
RECRUITING
Laquila
Azienda Ospedaliera Luigi Sacco
RECRUITING
Milan
Azienda Ospedaliero Universitaria di Modena
RECRUITING
Modena
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
RECRUITING
Perugia
Fondazione Policlinico Tor Vergata
RECRUITING
Roma
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyo-ku
Tokyo Teishin Hospital
RECRUITING
Chiyoda-ku
Noguchi Dermatology Clinic
RECRUITING
Kamimashiki-gun
Dokkyo Medical University Saitama Medical Center
RECRUITING
Koshigaya-shi
Kawasaki Medical School Hospital
RECRUITING
Kurashiki-shi
Mito Kyodo General Hospital
RECRUITING
Mito
Nagasaki University Hospital
RECRUITING
Nagasaki
Kochi Medical School Hospital
RECRUITING
Nankoku-shi
Ogaki Municipal Hospital
RECRUITING
Ogaki-shi
Hayami Dermatology Clinic
RECRUITING
Osaka
Medical Corporation Kojinkai Sapporo Skin Clinic
RECRUITING
Sapporo
Tokyo Medical University Hospital
RECRUITING
Shinjyuku-ku
Shirasaki Dermatology Clinic
RECRUITING
Takaoka-shi
National Defense Medical College hospital
RECRUITING
Tokorozawa-shi
Fujita Health University Hospital
RECRUITING
Toyoake-shi
Latvia
J Kisis
RECRUITING
Riga
Outpatient clinic Veselibas Centrs 4
RECRUITING
Riga
Outpatient clinic Veselibascentrs 4
RECRUITING
Riga
Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A C
RECRUITING
Durango
Clínica de Enfermedades Crónicas y de Procedimientos Especiales
RECRUITING
Morelia
Netherlands
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Poland
Niepubliczny Zaklad Opieki Zdrowotnej
RECRUITING
Bialystok
AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
RECRUITING
Gdansk
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
RECRUITING
Katowice
Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
RECRUITING
Lodz
Dermedic Jacek Zdybski
RECRUITING
Ostrowiec Świętokrzyski
Uniwersytecki Szpital Kliniczny imienia Fryderyka Chopina w Rzeszowie
TERMINATED
Rzeszów
Velocity Skierniewice Spolka z Ograniczona Odpowiedzialnoscia
RECRUITING
Skierniewice
Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
RECRUITING
Sosnowiec
Royalderm Agnieszka Nawrocka
RECRUITING
Warsaw
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spolka Partnerska
RECRUITING
Wroclaw
DermMedica Spzoo Centrum Columbus
RECRUITING
Wroclaw
Portugal
Hospital Cuf Descobertas
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
RECRUITING
Lisbon
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
RECRUITING
Porto
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansansi, Gyeonggido
Asan Medical Center
RECRUITING
Seoul
Hallym University Kangnam Sacred Heart Hospital
RECRUITING
Seoul
Hanyang University Seoul Hospital
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
RECRUITING
Cluj-napoca
Spitalul Clinic Judetean Mures
RECRUITING
Târgu Mureş
Spain
Hospital General Universitario de Alicante
RECRUITING
Alicante
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitario de Gran Canaria Doctor Negrin
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Sweden
Diagnostiskt Centrum Hud i Sickla
RECRUITING
Nacka
Akademiska sjukhuset
RECRUITING
Uppsala
Switzerland
Inselspital Bern
RECRUITING
Bern
Universitaetsspital Zuerich
RECRUITING
Zuerich Flughafen
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Mackay Memorial Hospital Taipei Branch
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Turkey
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Adnan Menderes Universitesi Medical Faculty
RECRUITING
Aydin
Pamukkale Universitesi Tip Fakultesi Hastanesi
RECRUITING
Denizli
Gaziantep Universitesi Tip Fakultesi Hastanesi
RECRUITING
Gaziantep
Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi
RECRUITING
Izmir
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
RECRUITING
Samsun
United Kingdom
Queen Elizabeth University Hospital
RECRUITING
Glasgow
Chapel Allerton Hospital
RECRUITING
Leeds
Guys Hospital
RECRUITING
London
Royal London Hospital
RECRUITING
London
Ameli-Biogroup Limited
RECRUITING
Waltham Abbey
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2027-05-14
Participants
Target number of participants: 460
Treatments
Experimental: Arm A: Blinded Treatment
Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.
Experimental: Arm B: Blinded Treatment
Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.
Experimental: Arm C: Blinded Treatment
Participants will receive matching placebo SC during Treatment Period A and B.
Experimental: Arm D: Open-label
Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.
Related Therapeutic Areas
Sponsors
Leads: Amgen