A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
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
1 other identifier
interventional
469
29 countries
190
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2024
190 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2024
CompletedFirst Submitted
Initial submission to the registry
July 23, 2024
CompletedFirst Posted
Study publicly available on registry
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2027
ExpectedMay 5, 2026
May 1, 2026
1.7 years
July 23, 2024
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
Up to 24 weeks
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24
Up to 24 weeks
Secondary Outcomes (27)
Global: Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Week 24
Week 24
Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24
Baseline and Week 24
Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24
Baseline and Week 24
Global: Number of Participants Achieving Reduction in Weekly Average Daily Prurigo Nodularis Skin Pain Assessment at Week 24 in Those with Baseline NRS Above Cutoff
Baseline and Week 24
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
Baseline and Week 24
- +22 more secondary outcomes
Study Arms (4)
Arm A: Blinded Treatment
EXPERIMENTALParticipants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.
Arm B: Blinded Treatment
EXPERIMENTALParticipants will receive rocatinlimab dose 2 SC during Treatment Period A and B.
Arm C: Blinded Treatment
EXPERIMENTALParticipants will receive matching placebo SC during Treatment Period A and B.
Arm D: Open-label
EXPERIMENTALParticipants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.
Interventions
SC Injection
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (192)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Los Angeles Universal Research Center
Los Angeles, California, 90057, United States
Paradigm Clinical Research Center Inc
San Diego, California, 92108, United States
Wolverine Clinical Trials
Santa Ana, California, 92706, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
Southern Clinical Research
Miami, Florida, 33125, United States
University of Miami Hospital
Miami, Florida, 33125, United States
Miami Dermatology and Laser Institute
Miami, Florida, 33173, United States
Wellness Clinical Research
Miami Lakes, Florida, 33016, United States
Clinical Research Trials of Florida Inc
Tampa, Florida, 33607, United States
Olympian Clinical Research - Tampa
Tampa, Florida, 33615, United States
Emory University
Atlanta, Georgia, 30322, United States
Endeavor Health Clinical Trials Center
Skokie, Illinois, 60077, United States
The Indiana Clinical Trials Center PC
Plainfield, Indiana, 46168, United States
Revival Research Institute, LLC
Troy, Michigan, 48084, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10028, United States
Optima Research
Boardman, Ohio, 44512, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Wright State Physicians
Fairborn, Ohio, 45324, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
Center For Clinical Studies PLLC
Houston, Texas, 77004, United States
Clarity Dermatology
Lancaster, Texas, 75146, United States
Springville Dermatology
Springville, Utah, 84663, United States
Hospital Universitario Austral
Derqui, Pilar, Buenos Aires, B1629ODT, Argentina
Instituto de Investigaciones Clinicas de Cordoba
Córdoba, Córdoba Province, X5000AAW, Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, Distrito Federal, 1425, Argentina
Derma Internacional
Buenos Aires, Distrito Federal, C1426EGR, Argentina
Centro de investigacion clinica y epidemiologica
San Miguel D Tucuman, Tucumán Province, T4000DPL, Argentina
Parra Dermatologia
Mendoza, M5500AWD, Argentina
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217, Australia
Veracity Clinical Research
Woolloongabba, Queensland, 4102, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Ordensklinikum Linz Elisabethinen
Linz, 4020, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Universitaire Ziekenhuizen Leuven Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000, Belgium
Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
Salvador, Estado de Bahia, 41820-020, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Universidade Estadual Paulista Julio de Mesquita Filho
Botucatu, São Paulo, 18618-686, Brazil
Fundacao Abc - Centro Univ Fmabc
Santo André, São Paulo, 09060-870, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-002, Brazil
IBPClin Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180, Brazil
Doctor Chih-Ho Hong Medical Incorporated
Surrey, British Columbia, V3R 6A7, Canada
Skincare Studio
St. John's, Newfoundland and Labrador, A1E 1V4, Canada
CCA Medical Research Corp
Ajax, Ontario, L1S 7K8, Canada
Centricity Research London Victoria
London, Ontario, N6A 2C2, Canada
Lovegrove Dermatology
London, Ontario, N6A 5R9, Canada
Lynderm Research Inc
Markham, Ontario, L3P 1X3, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4B 1L1, Canada
Toronto Research Centre Inc
Toronto, Ontario, M3H 5Y8, Canada
AvantDerm
Toronto, Ontario, M5A 3R6, Canada
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, G1V 4X7, Canada
Enroll SpA
Providencia, Santiago Metropolitan, 7500587, Chile
Centro Medico Skinmed Spa
Santiago, 7580206, Chile
Fundacion Innovacion Cardiovascular Clinica Ensenada
Santiago, 8380465, Chile
Centro Internacional de Estudios Clinicos
Santiago, Chile
Clinical Research Chile SpA
Valdivia, 5110683, Chile
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
The First Affiliated Hospital Sun-Yat Sen University
Guangzhou, Guangdong, 510080, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, 510515, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Sanmenxia Central Hospital
Sanmenxia, Henan, 472099, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, 214043, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Affiliated Hospital Of Xi An Jiaotong University
Xi'an, Shaanxi, 71004, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443, China
Chengdu Second Peoples Hospital
Chengdu, Sichuan, 610017, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The Second Affliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101, China
Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
Hangzhou, Zhejiang, 310020, China
Clinical Research Services Helsinki
Helsinki, 00180, Finland
Oulun Yliopistollinen sairaala
Oulu, 90029, Finland
Terveystalo Tampere
Tampere, 33100, Finland
Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
Brest, 29200, France
Centre Hospitalier Le Mans
Le Mans, 72037, France
Cabinet du Docteur Ruer-Mulard Mireille
Martigues, 13500, France
Centre Hospitalier Universitaire Archet 2
Nice, 06202, France
Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
Rouen, 76031, France
Universitaetsklinikum Augsburg
Augsburg, 86156, Germany
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, 12203, Germany
Rosenpark Research GmbH
Darmstadt, 64283, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, 24105, Germany
Universitaetsmedizin Mainz
Mainz, 55101, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Hautarztpraxis Mortazawi
Remscheid, 42897, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Helios Klinikum Wuppertal
Wuppertal, 42283, Germany
University General Hospital Attikon
Athens, 12462, Greece
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Athens, 16121, Greece
General Hospital Of Nea Ionia Konstantopouleio Patision
Nea Ionia, 14233, Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, 54643, Greece
Papageorgiou General Hospital
Thessaloniki, 56429, Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Derm-Surg Kft
Kaposvár, 7400, Hungary
DermaMed Research Kft
Orosháza, 5900, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7632, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, 6720, Hungary
Ospedale San Salvatore
LAquila, 67100, Italy
Azienda Ospedaliera Luigi Sacco
Milan, 20157, Italy
Azienda Ospedaliero Universitaria di Modena
Modena, 41124, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06156, Italy
Fondazione Policlinico Tor Vergata
Roma, 00133, Italy
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192, Japan
Ogaki Municipal Hospital
Ogaki-shi, Gifu, 503-8502, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic
Sapporo, Hokkaido, 060-0063, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015, Japan
Kochi Medical School Hospital
Nankoku-shi, Kochi, 783-8505, Japan
Noguchi Dermatology Clinic
Kamimashiki-gun, Kumamoto, 861-3106, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Kawasaki Medical School Hospital
Kurashiki-shi, Okayama-ken, 701-0192, Japan
Hayami Dermatology Clinic
Osaka, Osaka, 537-0013, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, 343-8555, Japan
National Defense Medical College hospital
Tokorozawa-shi, Saitama, 359-8513, Japan
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8519, Japan
Tokyo Teishin Hospital
Chiyoda-ku, Tokyo, 102-8798, Japan
Shirasaki Dermatology Clinic
Takaoka-shi, Toyama, 933-0871, Japan
Tokyo Medical University Hospital
Shinjyuku-ku, 160-0023, Japan
J Kisis
Riga, 1003, Latvia
Outpatient clinic Veselibas Centrs 4
Riga, 1003, Latvia
Outpatient clinic Veselibascentrs 4
Riga, LV-1013, Latvia
Clínica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia, Michoacán, 58249, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A C
Durango, 34000, Mexico
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej
Bialystok, 15-453, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
Gdansk, 80-280, Poland
GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
Katowice, 40-600, Poland
Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
Lodz, 91-495, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400, Poland
Uniwersytecki Szpital Kliniczny imienia Fryderyka Chopina w Rzeszowie
Rzeszów, 35-055, Poland
Velocity Skierniewice Spolka z Ograniczona Odpowiedzialnoscia
Skierniewice, 96-100, Poland
Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
Sosnowiec, 41-200, Poland
Royalderm Agnieszka Nawrocka
Warsaw, 02-962, Poland
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spolka Partnerska
Wroclaw, 50-566, Poland
DermMedica Spzoo Centrum Columbus
Wroclaw, 51-503, Poland
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Hospital Cuf Descobertas
Lisbon, 1998-018, Portugal
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
Porto, 4099-001, Portugal
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, 400347, Romania
Spitalul Clinic Judetean Mures
Târgu Mureş, 540613, Romania
Korea University Ansan Hospital
Ansansi, Gyeonggido, 15355, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Hospital General Universitario de Alicante
Alicante, Valencia, 03010, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Diagnostiskt Centrum Hud i Sickla
Nacka, 131 54, Sweden
Akademiska sjukhuset
Uppsala, 751 85, Sweden
Inselspital Bern
Bern, 3010, Switzerland
Universitaetsspital Zuerich
Zuerich Flughafen, 8058, Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Mackay Memorial Hospital Taipei Branch
Taipei, 10449, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305, Taiwan
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Adnan Menderes Universitesi Medical Faculty
Aydin, 09100, Turkey (Türkiye)
Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli, 20160, Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi
Izmir, 35390, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55200, Turkey (Türkiye)
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Chapel Allerton Hospital
Leeds, LS7 4SA, United Kingdom
Royal London Hospital
London, E11 1NR, United Kingdom
Guys Hospital
London, SE1 9RT, United Kingdom
Ameli-Biogroup Limited
Waltham Abbey, EN9 1JH, United Kingdom
Related Links
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2024
First Posted
July 30, 2024
Study Start
July 18, 2024
Primary Completion
April 17, 2026
Study Completion (Estimated)
January 17, 2027
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.