A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
- Registration Number
- NCT06527404
- Lead Sponsor
- Amgen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 460
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Blinded Treatment Rocatinlimab Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B. Arm C: Blinded Treatment Placebo Participants will receive matching placebo SC during Treatment Period A and B. Arm B: Blinded Treatment Rocatinlimab Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B. Arm D: Open-label Rocatinlimab Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.
- Primary Outcome Measures
Name Time Method 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 Assessment at Week 24 Up to 24 weeks
- Secondary Outcome Measures
Name Time Method Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24 in Participants with Baseline Weekly Average Score Greater Than a Cutoff Score Baseline and week 24 Change from Baseline in Quality of Life Assessment Score at Week 16 Baseline and week 16 Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 24 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 US Only: Number of Participants with Improvement in Prurigo Nodularis Assessment at Week 24 Week 24 Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 16 Baseline and Week 16 Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 16 Week 16 Change from Baseline in Weekly Average of Daily Itch Score at Week 24 Baseline and Week 24 Change from Baseline in Prurigo Nodularis Assessment Score at Week 24 Baseline and Week 24 Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Week 24 in Participants with Baseline Score Greater Than a Cutoff Score Baseline and Week 24 Change from Baseline in Quality of Life Assessment Score at Week 24 Baseline and Week 24 Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 24 Baseline and Week 24 Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24 Baseline and Week 24 Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Up to approximately Week 68 An adverse event (AE) is any untoward medical occurrence in a clinical study subject irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs. A serious TEAE is any untoward medical occurrence that meets one of the following criteria: Is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or another medically important serious event.
Number of Participants Experiencing AEs of Special Interest (EOIs) Up to approximately Week 68 Number of Participants with Anti-rocatinlimab Antibodies Baseline to Week 68 Serum Concentrations of Rocatinlimab Baseline to Week 52 Trough Concentration (Ctrough) of Rocatinlimab Baseline to Week 52
Trial Locations
- Locations (180)
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
🇺🇸Tustin, California, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Wellness Clinical Research
🇺🇸Miami Lakes, 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
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
🇦🇷Cordoba, Córdoba, Argentina
Instituto de Neumonologia y Dermatologia
🇦🇷Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina
Derma Internacional
🇦🇷Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina
Centro de investigacion clinica y epidemiologica
🇦🇷San Miguel D Tucuman, Tucuman, 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
🇧🇪Bruxelles, Belgium
Universitaire Ziekenhuizen Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
🇧🇪Liege, Belgium
Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
🇧🇷Salvador, Bahia, Brazil
Doctor Chih-Ho Hong Medical Incorporated
🇨🇦Surrey, British Columbia, 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
🇨🇦Quebec, Canada
Enroll SpA
🇨🇱Providencia, Santiago, 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, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, 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, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, Shanghai, China
Chengdu Second Peoples Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, 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 Cedex 9, 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 Cedex, 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, Germany
Universitaetsmedizin Mainz
🇩🇪Mainz, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Hautarztpraxis Mortazawi
🇩🇪Remscheid, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, 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
🇭🇺Kaposvar, Hungary
DermaMed Research Kft
🇭🇺Oroshaza, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pecs, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
🇭🇺Szeged, Hungary
Ospedale San Salvatore
🇮🇹LAquila, Italy
Azienda Ospedaliera Luigi Sacco
🇮🇹Milano, 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, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki-shi, Gifu, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Mito Kyodo General Hospital
🇯🇵Mito-shi, Ibaraki, Japan
Kochi Medical School Hospital
🇯🇵Nankoku-shi, Kochi, Japan
Noguchi Dermatology Clinic
🇯🇵Kamimashiki-gun, Kumamoto, Japan
Nagasaki University Hospital
🇯🇵Nagasaki-shi, Nagasaki, Japan
Hayami Dermatology Clinic
🇯🇵Osaka-shi, 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
Korea University Ansan Hospital
🇰🇷Ansansi, Gyeonggido, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
J Kisis
🇱🇻Riga, Latvia
Outpatient clinic Veselibas Centrs 4
🇱🇻Riga, Latvia
Outpatient clinic Veselibascentrs 4
🇱🇻Riga, Latvia
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 Swietokrzyski, Poland
Uniwersytecki Szpital Kliniczny imienia Fryderyka Chopina w Rzeszowie
🇵🇱Rzeszow, Poland
Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
🇵🇱Sosnowiec, Poland
Royalderm Agnieszka Nawrocka
🇵🇱Warszawa, 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
🇵🇹Lisboa, Portugal
Hospital Cuf Descobertas
🇵🇹Lisboa, 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
🇷🇴Targu Mures, Romania
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Andalucía, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Aragón, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
🇪🇸Las Palmas de Gran Canaria, Canarias, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Comunidad Valenciana, 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, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital Taipei Branch
🇨🇳Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Ankara Bilkent Sehir Hastanesi
🇹🇷Ankara, Turkey
Adnan Menderes Universitesi Medical Faculty
🇹🇷Aydin, Turkey
Pamukkale Universitesi Tip Fakultesi Hastanesi
🇹🇷Denizli, Turkey
Gaziantep Universitesi Tip Fakultesi Hastanesi
🇹🇷Gaziantep, Turkey
Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi
🇹🇷Izmir, Turkey
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
🇹🇷Samsun, Turkey
Chapel Allerton Hospital
🇬🇧Leeds, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
Guys Hospital
🇬🇧London, United Kingdom
Ameli-Biogroup Limited
🇬🇧Waltham Abbey, United Kingdom