A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

July 24, 2026 updated by: Amgen

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
469

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Mendoza, Argentina, M5500AWD
        • Parra Dermatología
    • 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 Neumonologia Y Dermatologia
      • 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 Misericordia 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 Clinicos
      • 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 Régional Universitaire de Brest - Hôpital 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 - Hôpital 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 Sofía
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
Time Frame: Up to 24 weeks
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
Time Frame: Up to 24 weeks
Up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24
Time Frame: Baseline and 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
Time Frame: Baseline and Week 24
Baseline and Week 24
Global: Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Week 24
Time Frame: 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
Time Frame: Baseline and Week 24
Baseline and Week 24
US Only: Number of Participants with Improvement in Prurigo Nodularis Stage Assessment at Week 24
Time Frame: Week 24
Week 24
US Only: Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24
Time Frame: 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
Time Frame: Week 24
Week 24
Change from Baseline in Weekly Average of Daily Itch Score at Weeks 24, 36 and 52
Time Frame: Baseline, Week 24, Week 36 and Week 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
Time Frame: Baseline, Week 36 and Week 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
Time Frame: Baseline, Week 16, Week 36 and Week 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
Time Frame: Week 36 and Week 52
Week 36 and Week 52
Change from Baseline in Prurigo Nodularis Stage Assessment Score at Week 24, 36, and 52
Time Frame: Baseline, Week 24, Week 36 and Week 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
Time Frame: Week 36 and Week 52
Week 36 and Week 52
Number of Participants Achieving Improvement in Prurigo Nodularis Activity Assessment Score at Weeks 24, 36 and 52
Time Frame: Week 24, Week 36 and Week 52
Week 24, Week 36 and Week 52
Change from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52
Time Frame: Baseline, Week 24, Week 36 and Week 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
Time Frame: Baseline, Week 24, Week 36 and Week 52
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
Time Frame: Baseline, Week 24, Week 36 and Week 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
Time Frame: Baseline, Week 24, Week 36 and Week 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
Time Frame: Baseline, Week 24, Week 36 and Week 52
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
Time Frame: Baseline, Week 36 and Week 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
Time Frame: Baseline, Week 36 and Week 52
Baseline, Week 36 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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