A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
NCT ID: NCT06527404
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
469 participants
INTERVENTIONAL
2024-07-18
2027-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: Blinded Treatment
Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.
Rocatinlimab
SC Injection
Arm B: Blinded Treatment
Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.
Rocatinlimab
SC Injection
Arm C: Blinded Treatment
Participants will receive matching placebo SC during Treatment Period A and B.
Placebo
SC Injection
Arm D: Open-label
Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.
Rocatinlimab
SC Injection
Interventions
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Rocatinlimab
SC Injection
Placebo
SC Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20230053
Identifier Type: -
Identifier Source: org_study_id
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