AzTrials
AzTrials

Prurigo NodularisPhase 3NCT06527404

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

A Phase 3 study testing Rocatinlimab in people with Prurigo Nodularis, run by Amgen at 192 sites in 30 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Prurigo Nodularis
What is being tested?
Rocatinlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
469 participants
Where
192 sitesin 30 countries
Study dates
18 Jul 2024to 25 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

192 sites in 30 countries.

192 sites in 30 countries

United States24 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Optima Research

    Boardman, Ohio, 44512

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Wright State Physicians

    Fairborn, Ohio, 45324

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Center For Clinical Studies PLLC

    Houston, Texas, 77004

  • Clarity Dermatology

    Lancaster, Texas, 75146

  • Los Angeles Universal Research Center

    Los Angeles, California, 90057

  • Southern Clinical Research

    Miami, Florida, 33125

  • University of Miami Hospital

    Miami, Florida, 33125

  • Miami Dermatology and Laser Institute

    Miami, Florida, 33173

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10028

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • The Indiana Clinical Trials Center PC

    Plainfield, Indiana, 46168

  • Paradigm Clinical Research Center Inc

    San Diego, California, 92108

  • Wolverine Clinical Trials

    Santa Ana, California, 92706

  • Endeavor Health Clinical Trials Center

    Skokie, Illinois, 60077

  • Springville Dermatology

    Springville, Utah, 84663

  • Clinical Research Trials of Florida Inc

    Tampa, Florida, 33607

  • Olympian Clinical Research - Tampa

    Tampa, Florida, 33615

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

Other trials in United States

China20 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Chengdu Second Peoples Hospital

    Chengdu, Sichuan, 610017

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • The First Affiliated Hospital Sun-Yat Sen University

    Guangzhou, Guangdong, 510080

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510091

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510515

  • Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University

    Hangzhou, Zhejiang, 310020

  • The Second Affliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101

  • Dermatology Hospital of Jiangxi Province

    Nanchang, Jiangxi, 330000

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Sanmenxia Central Hospital

    Sanmenxia, Henan, 472099

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality, 200443

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu, 214043

  • The Second Affiliated Hospital Of Xi An Jiaotong University

    Xi'an, Shaanxi, 71004

Other trials in China

Japan15 sites

  • Institute of Science Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8519

  • Tokyo Teishin Hospital

    Chiyoda-ku, Tokyo, 102-8798

  • Noguchi Dermatology Clinic

    Kamimashiki-gun, Kumamoto, 861-3106

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya-shi, Saitama, 343-8555

  • Kawasaki Medical School Hospital

    Kurashiki-shi, Okayama-ken, 701-0192

  • Mito Kyodo General Hospital

    Mito, Ibaraki, 310-0015

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Kochi Medical School Hospital

    Nankoku-shi, Kochi, 783-8505

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502

  • Hayami Dermatology Clinic

    Osaka, Osaka, 537-0013

  • Medical Corporation Kojinkai Sapporo Skin Clinic

    Sapporo, Hokkaido, 060-0063

  • Tokyo Medical University Hospital

    Shinjyuku-ku, 160-0023

  • Shirasaki Dermatology Clinic

    Takaoka-shi, Toyama, 933-0871

  • National Defense Medical College hospital

    Tokorozawa-shi, Saitama, 359-8513

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken, 470-1192

Other trials in Japan

Canada12 sites

  • CCA Medical Research Corp

    Ajax, Ontario, L1S 7K8

  • Centricity Research London Victoria

    London, Ontario, N6A 2C2

  • Lovegrove Dermatology

    London, Ontario, N6A 5R9

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche Dermatologique du Quebec Metropolitain

    Québec, Quebec, G1V 4X7

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario, L4B 1L1

  • Skincare Studio

    St. John's, Newfoundland and Labrador, A1E 1V4

  • Doctor Chih-Ho Hong Medical Incorporated

    Surrey, British Columbia, V3R 6A7

  • Toronto Research Centre Inc

    Toronto, Ontario, M3H 5Y8

  • AvantDerm

    Toronto, Ontario, M5A 3R6

  • Alliance Clinical Trials

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Poland12 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej

    Bialystok, 15-453

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy

    Gdansk, 80-280

  • GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero

    Katowice, 40-600

  • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne

    Lodz, 91-495

  • Dermedic Jacek Zdybski

    Ostrowiec Świętokrzyski, 27-400

  • Uniwersytecki Szpital Kliniczny imienia Fryderyka Chopina w Rzeszowie

    Rzeszów, 35-055

  • Velocity Skierniewice Spolka z Ograniczona Odpowiedzialnoscia

    Skierniewice, 96-100

  • Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych

    Sosnowiec, 41-200

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02-962

  • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spolka Partnerska

    Wroclaw, 50-566

  • DermMedica Spzoo Centrum Columbus

    Wroclaw, 51-503

Other trials in Poland

Germany11 sites

  • Universitaetsklinikum Augsburg

    Augsburg, 86156

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • Charite - Universitaetsmedizin Berlin, Campus Virchow

    Berlin, 12203

  • Rosenpark Research GmbH

    Darmstadt, 64283

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Universitaetsklinikum Schleswig-Holstein - Kiel

    Kiel, 24105

  • Universitaetsmedizin Mainz

    Mainz, 55101

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Hautarztpraxis Mortazawi

    Remscheid, 42897

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Helios Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

Spain8 sites

  • Hospital General Universitario de Alicante

    Alicante, Valencia, 03010

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Catalonia, 08916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, Canary Islands, 35010

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009

Other trials in Spain

South Korea7 sites

  • Korea University Ansan Hospital

    Ansansi, Gyeonggido, 15355

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Asan Medical Center

    Seoul, 05505

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

Other trials in South Korea

Argentina6 sites

  • Instituto de Neumonologia y Dermatologia

    Buenos Aires, Distrito Federal, 1425

  • Derma Internacional

    Buenos Aires, Distrito Federal, C1426EGR

  • Instituto de Investigaciones Clinicas de Cordoba

    Córdoba, Córdoba Province, X5000AAW

  • Hospital Universitario Austral

    Derqui, Pilar, Buenos Aires, B1629ODT

  • Parra Dermatologia

    Mendoza, M5500AWD

  • Centro de investigacion clinica y epidemiologica

    San Miguel D Tucuman, Tucumán Province, T4000DPL

Other trials in Argentina

Brazil6 sites

  • Universidade Estadual Paulista Julio de Mesquita Filho

    Botucatu, São Paulo, 18618-686

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • IBPClin Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro, 20241-180

  • Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda

    Salvador, Estado de Bahia, 41820-020

  • Fundacao Abc - Centro Univ Fmabc

    Santo André, São Paulo, 09060-870

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo, 05403-002

Other trials in Brazil

Hungary6 sites

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Derm-Surg Kft

    Kaposvár, 7400

  • DermaMed Research Kft

    Orosháza, 5900

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7632

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

    Szeged, 6720

Other trials in Hungary

Turkey (Türkiye)6 sites

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Adnan Menderes Universitesi Medical Faculty

    Aydin, 09100

  • Pamukkale Universitesi Tip Fakultesi Hastanesi

    Denizli, 20160

  • Gaziantep Universitesi Tip Fakultesi Hastanesi

    Gaziantep, 27310

  • Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi

    Izmir, 35390

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55200

Other trials in Turkey (Türkiye)

Australia5 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • St George Dermatology and Skin Cancer Centre

    Kogarah, New South Wales, 2217

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Veracity Clinical Research

    Woolloongabba, Queensland, 4102

Other trials in Australia

Chile5 sites

  • Enroll SpA

    Providencia, Santiago Metropolitan, 7500587

  • Centro Medico Skinmed Spa

    Santiago, 7580206

  • Fundacion Innovacion Cardiovascular Clinica Ensenada

    Santiago, 8380465

  • Centro Internacional de Estudios Clinicos

    Santiago

  • Clinical Research Chile SpA

    Valdivia, 5110683

Other trials in Chile

France5 sites

  • Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan

    Brest, 29200

  • Centre Hospitalier Le Mans

    Le Mans, 72037

  • Cabinet du Docteur Ruer-Mulard Mireille

    Martigues, 13500

  • Centre Hospitalier Universitaire Archet 2

    Nice, 06202

  • Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle

    Rouen, 76031

Other trials in France

Greece5 sites

  • University General Hospital Attikon

    Athens, 12462

  • Andreas Syngros Hospital Of Venereal And Dermatological Diseases

    Athens, 16121

  • General Hospital Of Nea Ionia Konstantopouleio Patision

    Nea Ionia, 14233

  • Ippokratio General Hospital of Thessaloniki

    Thessaloniki, 54643

  • Papageorgiou General Hospital

    Thessaloniki, 56429

Other trials in Greece

Italy5 sites

  • Ospedale San Salvatore

    LAquila, 67100

  • Azienda Ospedaliera Luigi Sacco

    Milan, 20157

  • Azienda Ospedaliero Universitaria di Modena

    Modena, 41124

  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

    Perugia, 06156

  • Fondazione Policlinico Tor Vergata

    Roma, 00133

Other trials in Italy

Taiwan5 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • National Taiwan University Hospital

    Taipei, 10002

  • Mackay Memorial Hospital Taipei Branch

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

United Kingdom5 sites

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Chapel Allerton Hospital

    Leeds, LS7 4SA

  • Royal London Hospital

    London, E11 1NR

  • Guys Hospital

    London, SE1 9RT

  • Ameli-Biogroup Limited

    Waltham Abbey, EN9 1JH

Other trials in United Kingdom

Belgium3 sites

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Universitaire Ziekenhuizen Leuven Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

Other trials in Belgium

Finland3 sites

  • Clinical Research Services Helsinki

    Helsinki, 00180

  • Oulun Yliopistollinen sairaala

    Oulu, 90029

  • Terveystalo Tampere

    Tampere, 33100

Other trials in Finland

Latvia3 sites

  • J Kisis

    Riga, 1003

  • Outpatient clinic Veselibas Centrs 4

    Riga, 1003

  • Outpatient clinic Veselibascentrs 4

    Riga, LV-1013

Other trials in Latvia

Portugal3 sites

  • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

    Lisbon, 1649-035

  • Hospital Cuf Descobertas

    Lisbon, 1998-018

  • Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio

    Porto, 4099-001

Other trials in Portugal

Austria2 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020

Other trials in Austria

Mexico2 sites

  • Instituto de Investigaciones Aplicadas a la Neurociencia A C

    Durango, 34000

  • Clínica de Enfermedades Crónicas y de Procedimientos Especiales

    Morelia, Michoacán, 58249

Other trials in Mexico

Romania2 sites

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    Cluj-Napoca, 400347

  • Spitalul Clinic Judetean Mures

    Târgu Mureş, 540613

Other trials in Romania

Sweden2 sites

  • Diagnostiskt Centrum Hud i Sickla

    Nacka, 131 54

  • Akademiska sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Switzerland2 sites

  • Inselspital Bern

    Bern, 3010

  • Universitaetsspital Zuerich

    Zuerich Flughafen, 8058

Other trials in Switzerland

Hong Kong1 site

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

Netherlands1 site

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: 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).

Being tested
Rocatinlimab, Placebo
Keywords
Rocatinlimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RocatinlimabDrug

    Also called AMG 451

    SC Injection

  • PlaceboDrug

    SC Injection

Study groups in NCT06527404
Study groupRoleWhat they receive
Arm A: Blinded TreatmentExperimentalParticipants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.
Receives: Drug: Rocatinlimab
Arm B: Blinded TreatmentExperimentalParticipants will receive rocatinlimab dose 2 SC during Treatment Period A and B.
Receives: Drug: Rocatinlimab
Arm C: Blinded TreatmentExperimentalParticipants will receive matching placebo SC during Treatment Period A and B.
Receives: Drug: Placebo
Arm D: Open-labelExperimentalParticipants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.
Receives: Drug: Rocatinlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24

    Measured: Up to 24 weeks

  2. US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24

    Measured: Up to 24 weeks

Secondary outcomes (22)

  1. Global: Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Week 24

    Measured: Week 24

  2. Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24

    Measured: Baseline and Week 24

  3. Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24

    Measured: Baseline and Week 24

  4. 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

    Measured: Baseline and Week 24

  5. US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24

    Measured: Baseline and Week 24

  6. US Only: Number of Participants with Improvement in Prurigo Nodularis Stage Assessment at Week 24

    Measured: Week 24

  7. US Only: Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24

    Measured: Week 24

  8. 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

    Measured: Week 24

  9. Change from Baseline in Weekly Average of Daily Itch Score at Weeks 24, 36 and 52

    Measured: Baseline, Week 24, Week 36 and Week 52

  10. Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 36 and 52

    Measured: Baseline, Week 36 and Week 52

  11. Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Weeks 16, 36 and 52

    Measured: Baseline, Week 16, Week 36 and Week 52

  12. Number of Participants Achieving Weekly Average of Daily Itch Score Less than a Cutoff Score at Week 36 and 52

    Measured: Week 36 and Week 52

  13. Change from Baseline in Prurigo Nodularis Stage Assessment Score at Week 24, 36, and 52

    Measured: Baseline, Week 24, Week 36 and Week 52

  14. Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Weeks 36 and 52

    Measured: Week 36 and Week 52

  15. Number of Participants Achieving Improvement in Prurigo Nodularis Activity Assessment Score at Weeks 24, 36 and 52

    Measured: Week 24, Week 36 and Week 52

  16. Change from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52

    Measured: Baseline, Week 24, Week 36 and Week 52

  17. 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

    Measured: Baseline, Week 24, Week 36 and Week 52

  18. Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Weeks 24, 36 and 52

    Measured: Baseline, Week 24, Week 36 and Week 52

  19. Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52

    Measured: Baseline, Week 24, Week 36 and Week 52

  20. 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

    Measured: Baseline, Week 24, Week 36 and Week 52

  21. Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 36 and 52

    Measured: Baseline, Week 36 and Week 52

  22. 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

    Measured: Baseline, Week 36 and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2024
  2. Study start18 Jul 2024
  3. Primary completion17 Apr 2026
  4. Study completion25 Jun 2026

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06527404
Sponsor's protocol ID
20230053
Status last verified
Jul 2026
First submitted
23 Jul 2024
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rocatinlimab in people with Prurigo Nodularis, run by Amgen at 192 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United States, China, Japan, Canada, Poland and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24 (time frame: Up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06527404.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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