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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Drug: Rocatinlimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 469
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Mendoza, Argentina, M5500AWD
    • Parra Dermatologia
  • Buenos Aires
    • Derqui, Pilar, Buenos Aires, Argentina, B1629ODT
      • Hospital Universitario Austral
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, X5000AAW
      • Instituto de Investigaciones Clinicas de Cordoba
  • Distrito Federal
    • Buenos Aires, Distrito Federal, Argentina, 1425
      • Instituto de Neumonología Y Dermatología
    • Buenos Aires, Distrito Federal, Argentina, C1426EGR
      • Derma Internacional
  • Tucumán Province
    • San Miguel D Tucuman, Tucumán Province, Argentina, T4000DPL
      • Centro de investigacion clinica y epidemiologica
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Dermatology and Skin Cancer Centre
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitaet Graz
  • Linz, Austria, 4020
    • Ordensklinikum Linz Elisabethinen
• Belgium
  • Brussels, Belgium, 1200
    • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven Gasthuisberg
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege - Sart Tilman
• Brazil
  • Rio de Janeiro, Brazil, 20241-180
    • IBPCLIN Instituto Brasil de Pesquisa Clinica
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41820-020
      • Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • São Paulo
    • Botucatu, São Paulo, Brazil, 18618-686
      • Universidade Estadual Paulista Julio de Mesquita Filho
    • Santo André, São Paulo, Brazil, 09060-870
      • Fundacao Abc - Centro Univ Fmabc
    • São Paulo, São Paulo, Brazil, 05403-002
      • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Doctor Chih-Ho Hong Medical Incorporated
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1E 1V4
      • Skincare Studio
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research Corp
    • London, Ontario, Canada, N6A 5R9
      • Lovegrove Dermatology
    • London, Ontario, Canada, N6A 2C2
      • Centricity Research London Victoria
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKiN Centre for Dermatology
    • Richmond Hill, Ontario, Canada, L4B 1L1
      • York Dermatology Clinic and Research Centre
    • Toronto, Ontario, Canada, M5A 3R6
      • AvantDerm
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre Inc
    • Waterloo, Ontario, Canada, N2J 1C4
      • Alliance Clinical Trials
  • Quebec
    • Québec, Quebec, Canada, G1V 4X7
      • Centre de Recherche Dermatologique du Quebec metropolitain
• Chile
  • Santiago, Chile
    • Centro Internacional de Estudios Clínicos
  • Santiago, Chile, 7580206
    • Centro Medico Skinmed Spa
  • Santiago, Chile, 8380465
    • Fundacion Innovacion Cardiovascular Clinica Ensenada
  • Valdivia, Chile, 5110683
    • Clinical Research Chile SpA
  • Santiago Metropolitan
    • Providencia, Santiago Metropolitan, Chile, 7500587
      • Enroll Spa
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital Southern Medical University
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital Sun-Yat Sen University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Henan
    • Sanmenxia, Henan, China, 472099
      • Sanmenxia Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Wuxi, Jiangsu, China, 214043
      • Wuxi Peoples Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Dermatology Hospital of Jiangxi Province
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University
  • Shaanxi
    • Xi'an, Shaanxi, China, 71004
      • The Second Affiliated Hospital of Xi an Jiaotong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200443
      • Shanghai Skin Disease Hospital
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital affiliated to Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China, 610017
      • Chengdu Second Peoples Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650101
      • The Second Affliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310020
      • Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
• Finland
  • Helsinki, Finland, 00180
    • Clinical Research Services Helsinki
  • Oulu, Finland, 90029
    • Oulun yliopistollinen sairaala
  • Tampere, Finland, 33100
    • Terveystalo Tampere
• France
  • Brest, France, 29200
    • Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
  • Le Mans, France, 72037
    • Centre Hospitalier Le Mans
  • Martigues, France, 13500
    • Cabinet du Docteur Ruer-Mulard Mireille
  • Nice, France, 06202
    • Centre Hospitalier Universitaire Archet 2
  • Rouen, France, 76031
    • Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
• Germany
  • Augsburg, Germany, 86156
    • Universitaetsklinikum Augsburg
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 12203
    • Charite - Universitaetsmedizin Berlin, Campus Virchow
  • Darmstadt, Germany, 64283
    • Rosenpark Research GmbH
  • Dresden, Germany, 01307
    • Universitaetsklinikum Dresden
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein - Kiel
  • Mainz, Germany, 55101
    • Universitaetsmedizin Mainz
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Remscheid, Germany, 42897
    • Hautarztpraxis Mortazawi
  • Tübingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
  • Wuppertal, Germany, 42283
    • Helios Klinikum Wuppertal
• Greece
  • Athens, Greece, 12462
    • University General Hospital Attikon
  • Athens, Greece, 16121
    • Andreas Syngros Hospital Of Venereal And Dermatological Diseases
  • Nea Ionia, Greece, 14233
    • General Hospital Of Nea Ionia Konstantopouleio Patision
  • Thessaloniki, Greece, 56429
    • Papageorgiou General Hospital
  • Thessaloniki, Greece, 54643
    • Ippokratio General Hospital of Thessaloniki
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital, The University of Hong Kong
• Hungary
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Kaposvár, Hungary, 7400
    • Derm-Surg Kft
  • Orosháza, Hungary, 5900
    • DermaMed Research Kft
  • Pécs, Hungary, 7632
    • Pécsi Tudományegyetem Klinikai Központ
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
• Italy
  • LAquila, Italy, 67100
    • Ospedale San Salvatore
  • Milan, Italy, 20157
    • Azienda Ospedaliera Luigi Sacco
  • Modena, Italy, 41124
    • Azienda Ospedaliero Universitaria di Modena
  • Perugia, Italy, 06156
    • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
  • Roma, Italy, 00133
    • Fondazione Policlinico Tor Vergata
• Japan
  • Shinjyuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Aichi-ken
    • Toyoake-shi, Aichi-ken, Japan, 470-1192
      • Fujita Health University Hospital
  • Gifu
    • Ogaki-shi, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0063
      • Medical Corporation Kojinkai Sapporo Skin Clinic
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0015
      • Mito Kyodo General Hospital
  • Kochi
    • Nankoku-shi, Kochi, Japan, 783-8505
      • Kochi Medical School Hospital
  • Kumamoto
    • Kamimashiki-gun, Kumamoto, Japan, 861-3106
      • Noguchi Dermatology Clinic
  • Nagasaki
    • Nagasaki, Nagasaki, Japan, 852-8501
      • Nagasaki University Hospital
  • Okayama-ken
    • Kurashiki-shi, Okayama-ken, Japan, 701-0192
      • Kawasaki Medical School Hospital
  • Osaka
    • Osaka, Osaka, Japan, 537-0013
      • Hayami Dermatology Clinic
  • Saitama
    • Koshigaya-shi, Saitama, Japan, 343-8555
      • Dokkyo Medical University Saitama Medical Center
    • Tokorozawa-shi, Saitama, Japan, 359-8513
      • National Defense Medical College hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Institute of Science Tokyo Hospital
    • Chiyoda-ku, Tokyo, Japan, 102-8798
      • Tokyo Teishin Hospital
  • Toyama
    • Takaoka-shi, Toyama, Japan, 933-0871
      • Shirasaki Dermatology Clinic
• Latvia
  • Riga, Latvia, 1003
    • J Kisis
  • Riga, Latvia, 1003
    • Outpatient clinic Veselibas Centrs 4
  • Riga, Latvia, LV-1013
    • Outpatient clinic Veselibascentrs 4
• Mexico
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Aplicadas a la Neurociencia A C
  • Michoacán
    • Morelia, Michoacán, Mexico, 58249
      • Clinica de Enfermedades Crónicas y de Procedimientos Especiales
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
• Poland
  • Bialystok, Poland, 15-453
    • Niepubliczny Zaklad Opieki Zdrowotnej
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Gdansk, Poland, 80-280
    • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
  • Katowice, Poland, 40-600
    • GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
  • Lodz, Poland, 91-495
    • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • DERMEDIC Jacek Zdybski
  • Rzeszów, Poland, 35-055
    • Uniwersytecki Szpital Kliniczny imienia Fryderyka Chopina w Rzeszowie
  • Skierniewice, Poland, 96-100
    • Velocity Skierniewice Spolka z Ograniczona Odpowiedzialnoscia
  • Sosnowiec, Poland, 41-200
    • Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
  • Warsaw, Poland, 02-962
    • Royalderm Agnieszka Nawrocka
  • Wroclaw, Poland, 51-503
    • DermMedica Spzoo Centrum Columbus
  • Wroclaw, Poland, 50-566
    • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spolka Partnerska
• Portugal
  • Lisbon, Portugal, 1998-018
    • Hospital CUF Descobertas
  • Lisbon, Portugal, 1649-035
    • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
  • Porto, Portugal, 4099-001
    • Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
• Romania
  • Cluj-Napoca, Romania, 400347
    • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • Târgu Mureş, Romania, 540613
    • Spitalul Clinic Judetean Mures
• South Korea
  • Ansansi, Gyeonggido, South Korea, 15355
    • Korea University Ansan Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 07441
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, South Korea, 04763
    • Hanyang University Seoul Hospital
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Andalusia
    • Córdoba, Andalusia, Spain, 14004
      • Hospital Universitario Reina Sofia
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Universitario Miguel Servet
  • Canary Islands
    • Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
      • Hospital Universitario de Gran Canaria Doctor Negrín
  • Catalonia
    • Badalona, Catalonia, Spain, 08916
      • Hospital Universitari Germans Trias I Pujol
    • Barcelona, Catalonia, Spain, 08041
      • Hospital de la Santa Creu i Sant Pau
  • Valencia
    • Alicante, Valencia, Spain, 03010
      • Hospital General Universitario de Alicante
• Sweden
  • Nacka, Sweden, 131 54
    • Diagnostiskt Centrum Hud i Sickla
  • Uppsala, Sweden, 751 85
    • Akademiska sjukhuset
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Zuerich Flughafen, Switzerland, 8058
    • UniversitaetsSpital Zuerich
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital Taipei Branch
  • Taoyuan, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Sehir Hastanesi
  • Aydin, Turkey (Türkiye), 09100
    • Adnan Menderes Universitesi Medical Faculty
  • Denizli, Turkey (Türkiye), 20160
    • Pamukkale Universitesi Tip Fakultesi Hastanesi
  • Gaziantep, Turkey (Türkiye), 27310
    • Gaziantep Universitesi Tip Fakultesi Hastanesi
  • Izmir, Turkey (Türkiye), 35390
    • Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi
  • Samsun, Turkey (Türkiye), 55200
    • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital
  • Leeds, United Kingdom, LS7 4SA
    • Chapel Allerton Hospital
  • London, United Kingdom, SE1 9RT
    • Guys Hospital
  • London, United Kingdom, E11 1NR
    • Royal London Hospital
  • Waltham Abbey, United Kingdom, EN9 1JH
    • Ameli-Biogroup Limited
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Los Angeles, California, United States, 90057
      • Los Angeles Universal Research Center
    • San Diego, California, United States, 92108
      • Paradigm Clinical Research Center Inc
    • Santa Ana, California, United States, 92706
      • Wolverine Clinical Trials
  • Florida
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Miami, Florida, United States, 33125
      • University of Miami Hospital
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Institute
    • Miami, Florida, United States, 33125
      • Southern Clinical Research
    • Miami Lakes, Florida, United States, 33016
      • Wellness Clinical Research
    • Tampa, Florida, United States, 33615
      • Olympian Clinical Research - Tampa
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida Inc
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Endeavor Health Clinical Trials Center
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center PC
  • Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
  • New York
    • New York, New York, United States, 10028
      • Icahn School of Medicine at Mount Sinai
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Optima Research
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical
  • Texas
    • Houston, Texas, United States, 77004
      • Center For Clinical Studies PLLC
    • Lancaster, Texas, United States, 75146
      • Clarity Dermatology
  • Utah
    • Springville, Utah, United States, 84663
      • Springville Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Blinded Treatment; Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.	Drug: Rocatinlimab; SC Injection; Other Names: AMG 451
Experimental: Arm B: Blinded Treatment; Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.	Drug: Rocatinlimab; SC Injection; Other Names: AMG 451
Experimental: Arm C: Blinded Treatment; Participants will receive matching placebo SC during Treatment Period A and B.	Drug: Placebo; SC Injection
Experimental: Arm D: Open-label; Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.	Drug: Rocatinlimab; SC Injection; Other Names: AMG 451

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24		Baseline and Week 24
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	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.	Up to approximately Week 68
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
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
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
US Only: Number of Participants with Improvement in Prurigo Nodularis Stage Assessment at Week 24		Week 24
US Only: Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24		Week 24
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment at Week 24 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score		Week 24
Change from Baseline in Weekly Average of Daily Itch Score at Weeks 24, 36 and 52		Baseline, Week 24, Week 36 and Week 52
Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 36 and 52		Baseline, Week 36 and Week 52
Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Weeks 16, 36 and 52		Baseline, Week 16, Week 36 and Week 52
Number of Participants Achieving Weekly Average of Daily Itch Score Less than a Cutoff Score at Week 36 and 52		Week 36 and Week 52
Change from Baseline in Prurigo Nodularis Stage Assessment Score at Week 24, 36, and 52		Baseline, Week 24, Week 36 and Week 52
Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Weeks 36 and 52		Week 36 and Week 52
Number of Participants Achieving Improvement in Prurigo Nodularis Activity Assessment Score at Weeks 24, 36 and 52		Week 24, Week 36 and Week 52
Change from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52		Baseline, Week 24, Week 36 and Week 52
Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Score Greater Than or Equal to a Cutoff Score		Baseline, Week 24, Week 36 and Week 52
Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Weeks 24, 36 and 52		Baseline, Week 24, Week 36 and Week 52
Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52		Baseline, Week 24, Week 36 and Week 52
Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Weekly Average Score Greater Than or Equal to a Cutoff Score		Baseline, Week 24, Week 36 and Week 52
Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 36 and 52		Baseline, Week 36 and Week 52
Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 36 and 52 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score		Baseline, Week 36 and Week 52

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Actual): April 17, 2026
• Study Completion (Estimated): January 17, 2027

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rocatinlimab
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Prurigo; Neurodermatitis
• Other Study ID Numbers: 20230053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No