Clinical trial NCT06527404: A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prurigo Nodularis
Keywords: Rocatinlimab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-07-30
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
timeFrame: Up to 24 weeks
measure: US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Assessment at Week 24
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 24
timeFrame: Week 24
measure: Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24
timeFrame: Baseline and Week 24
measure: 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
timeFrame: Baseline and Week 24
measure: US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
timeFrame: Baseline and Week 24
measure: US Only: Number of Participants with Improvement in Prurigo Nodularis Assessment at Week 24
timeFrame: Week 24
measure: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 16
timeFrame: Week 16
measure: Change from Baseline in Weekly Average of Daily Itch Score at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Prurigo Nodularis Assessment Score at Week 24
timeFrame: Baseline and Week 24
measure: Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Week 24 in Participants with Baseline Score Greater Than a Cutoff Score
timeFrame: Baseline and Week 24
measure: Change from Baseline in Quality of Life Assessment Score at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Quality of Life Assessment Score at Week 16
timeFrame: Baseline and week 16
measure: Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24
timeFrame: Baseline and Week 24
measure: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24 in Participants with Baseline Weekly Average Score Greater Than a Cutoff Score
timeFrame: Baseline and week 24
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately Week 68
measure: Number of Participants Experiencing AEs of Special Interest (EOIs)
timeFrame: Up to approximately Week 68
measure: Number of Participants with Anti-rocatinlimab Antibodies
timeFrame: Baseline to Week 68
measure: Serum Concentrations of Rocatinlimab
timeFrame: Baseline to Week 52
measure: Trough Concentration (Ctrough) of Rocatinlimab
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Los Angeles
country: United States
facility: Los Angeles Universal Research Center
state: California
city: San Diego
country: United States
facility: Paradigm Clinical Research Center Inc
state: California
city: Tustin
country: United States
facility: Wolverine Clinical Trials
state: California
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research
state: Florida
city: Miami
country: United States
facility: Southern Clinical Research
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Institute
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida Inc
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research - Tampa
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Skokie
country: United States
facility: Endeavor Health Clinical Trials Center
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center PC
state: Indiana
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Boardman
country: United States
facility: Optima Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Houston
country: United States
facility: Center For Clinical Studies PLLC
state: Texas
city: Lancaster
country: United States
facility: Clarity Dermatology
state: Texas
city: Springville
country: United States
facility: Springville Dermatology
state: Utah
city: Derqui, Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Instituto de Investigaciones Clinicas de Cordoba
state: Córdoba
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto de Neumonologia y Dermatologia
state: Distrito Federal
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Derma Internacional
state: Distrito Federal
city: San Miguel D Tucuman
country: Argentina
facility: Centro de investigacion clinica y epidemiologica
state: Tucuman
city: Mendoza
country: Argentina
facility: Parra Dermatologia
city: Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Salvador
country: Brazil
facility: Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
state: Bahia
city: Surrey
country: Canada
facility: Doctor Chih-Ho Hong Medical Incorporated
state: British Columbia
city: Ajax
country: Canada
facility: CCA Medical Research Corp
state: Ontario
city: London
country: Canada
facility: Centricity Research London Victoria
state: Ontario
city: London
country: Canada
facility: Lovegrove Dermatology
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre Inc
state: Ontario
city: Toronto
country: Canada
facility: AvantDerm
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain
city: Providencia
country: Chile
facility: Enroll SpA
state: Santiago
city: Santiago
country: Chile
facility: Centro Medico Skinmed Spa
city: Santiago
country: Chile
facility: Fundacion Innovacion Cardiovascular Clinica Ensenada
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun-Yat Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Wuxi
country: China
facility: Wuxi Peoples Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
state: Jiangxi
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: XI An
country: China
facility: The Second Affiliated Hospital Of Xi An Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Second Peoples Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: The Second Affliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
state: Zhejiang
city: Helsinki
country: Finland
facility: Clinical Research Services Helsinki
city: Oulu
country: Finland
facility: Oulun Yliopistollinen sairaala
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
city: Le Mans Cedex 9
country: France
facility: Centre Hospitalier Le Mans
city: Martigues
country: France
facility: Cabinet du Docteur Ruer-Mulard Mireille
city: Nice
country: France
facility: Centre Hospitalier Universitaire Archet 2
city: Rouen Cedex
country: France
facility: Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
city: Augsburg
country: Germany
facility: Universitaetsklinikum Augsburg
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin, Campus Virchow
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Remscheid
country: Germany
facility: Hautarztpraxis Mortazawi
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Athens
country: Greece
facility: Andreas Syngros Hospital Of Venereal And Dermatological Diseases
city: Nea Ionia
country: Greece
facility: General Hospital Of Nea Ionia Konstantopouleio Patision
city: Thessaloniki
country: Greece
facility: Ippokratio General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Kaposvar
country: Hungary
facility: Derm-Surg Kft
city: Oroshaza
country: Hungary
facility: DermaMed Research Kft
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
city: LAquila
country: Italy
facility: Ospedale San Salvatore
city: Milano
country: Italy
facility: Azienda Ospedaliera Luigi Sacco
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
city: Roma
country: Italy
facility: Fondazione Policlinico Tor Vergata
city: Toyoake-shi
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Sapporo-shi
country: Japan
facility: Medical Corporation Kojinkai Sapporo Skin Clinic
state: Hokkaido
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Kamimashiki-gun
country: Japan
facility: Noguchi Dermatology Clinic
state: Kumamoto
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Osaka-shi
country: Japan
facility: Hayami Dermatology Clinic
state: Osaka
city: Koshigaya-shi
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
state: Saitama
city: Tokorozawa-shi
country: Japan
facility: National Defense Medical College hospital
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Tokyo Teishin Hospital
state: Tokyo
city: Takaoka-shi
country: Japan
facility: Shirasaki Dermatology Clinic
state: Toyama
city: Shinjyuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Ansansi, Gyeonggido
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Riga
country: Latvia
facility: J Kisis
city: Riga
country: Latvia
facility: Outpatient clinic Veselibas Centrs 4
city: Riga
country: Latvia
facility: Outpatient clinic Veselibascentrs 4
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Bialystok
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gdansk
country: Poland
facility: AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
city: Katowice
country: Poland
facility: GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
city: Lodz
country: Poland
facility: Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Rzeszow
country: Poland
facility: Uniwersytecki Szpital Kliniczny imienia Fryderyka Chopina w Rzeszowie
city: Sosnowiec
country: Poland
facility: Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spolka Partnerska
city: Wroclaw
country: Poland
facility: DermMedica Spzoo Centrum Columbus
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
city: Lisboa
country: Portugal
facility: Hospital Cuf Descobertas
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean Mures
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
state: Canarias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Nacka
country: Sweden
facility: Diagnostiskt Centrum Hud i Sickla
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zuerich Flughafen
country: Switzerland
facility: Universitaetsspital Zuerich
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital Taipei Branch
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Aydin
country: Turkey
facility: Adnan Menderes Universitesi Medical Faculty
city: Denizli
country: Turkey
facility: Pamukkale Universitesi Tip Fakultesi Hastanesi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: Guys Hospital
city: Waltham Abbey
country: United Kingdom
facility: Ameli-Biogroup Limited
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: