A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naïve Participants With Active Psoriatic Arthritis

Status: Recruiting
Location: See all (142) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening

• Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory

• Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis

• Have active plaque psoriasis with at least one psoriatic plaque of \>= 2 cm diameter or nail changes consistent with psoriasis

• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Locations
United States
Arkansas
Arthritis and Rheumatism Associates ARA Jonesboro
RECRUITING
Jonesboro
Florida
Omega Research Consultants
RECRUITING
Debary
Integral Rheumatology And Immunology Specialists
RECRUITING
Plantation
Clinical Research of West Florida
RECRUITING
Tampa
Illinois
Willow Rheumatology and Wellness PLLC
RECRUITING
Willowbrook
North Carolina
Joint and Muscle Research Institute
RECRUITING
Charlotte
Pennsylvania
Altoona Center For Clinical Research
COMPLETED
Duncansville
Texas
Arthritis and Rheumatology Research Institute
RECRUITING
Allen
Naiara Alvarez MD Integrative Rheumatology of South TX
RECRUITING
Harlingen
Other Locations
Argentina
Cosultorios Reumatologógicos Pampa
RECRUITING
Buenos Aires
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
RECRUITING
Buenos Aires
Mindout Research
RECRUITING
Buenos Aires
Arsema
RECRUITING
Ciudad De Buenos Aires
Centro Medico Privado de Reumatologia Tucuman
RECRUITING
Ciudad De San Miguel De Tucuman
Consultora Integral de Salud SRL
RECRUITING
Córdoba
MR Medicina Reumatologica
RECRUITING
San Fernando
Instituto Medico De Alta Complejidad (IMAC)
RECRUITING
San Isidro
Australia
Ipswich Hospital
RECRUITING
Ipswich
Rheumatology Research Unit
RECRUITING
Maroochydore
BJC Health
RECRUITING
Parramatta
Queen Elizabeth Hospital
RECRUITING
South Woodville
Royal Darwin Hospital
RECRUITING
Tiwi
Bulgaria
MC Medtech Services Ltd
RECRUITING
Haskovo
Exacta Medica
RECRUITING
Pleven
Medical Center Artmed
RECRUITING
Plovdiv
Medical Center Teodora
RECRUITING
Rousse
China
Beijing Tong Ren Hospital Capital Medical University
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Xiangya Hospital Central South University
RECRUITING
Changsha
Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
West China Hospital Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Nanfang Hospital of Southern Medical Hospital
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
Linyi City People Hospital
RECRUITING
Linyi
Jiangxi Provincial Peoples Hospital
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Pingxiang People's Hospital
RECRUITING
Pingxiang
Huashan Hospital Fudan University
RECRUITING
Shanghai
Shanghai skin disease hospital
RECRUITING
Shanghai
Shenzhen People s Hospital
RECRUITING
Shenzhen
The Third Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Shanxi Bethune Hospital
RECRUITING
Taiyuan
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Denmark
Aarhus University Hospital
RECRUITING
Aarhus N
Sydvestjysk Sygehus
RECRUITING
Esbjerg
Frederiksberg Hospital
RECRUITING
Frederiksberg
Regionshospitalet Godstrup
COMPLETED
Herning
Svendborg Hospital Odense University Hospital
RECRUITING
Svendborg
Vejle Sygehus
RECRUITING
Vejle
Germany
Fachklinik Bad Bentheim
RECRUITING
Bad Bentheim
Charite Universitaetsmedizin Berlin
RECRUITING
Berlin
ISA - Interdisciplinary Study Association GmbH
RECRUITING
Berlin
Universitatsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Medizinische Fakultat der Albert Ludwigs Universitat Freiburg
RECRUITING
Freiburg Im Breisgau
Hamburger Rheuma Forschungszentrum II
RECRUITING
Hamburg
Rheumazentrum Ruhrgebiet
RECRUITING
Herne
Studienzentrum Dr Schwarz Germany
RECRUITING
Langenau
Johannes Wesling Klinikum Minden
RECRUITING
Minden
Universitatsklinikum Tubingen
RECRUITING
Tübingen
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
RECRUITING
Budapest
Obudai Egeszsegugyi Centrum Kft
RECRUITING
Budapest
Qualiclinic Kft
RECRUITING
Budapest
Revita Kft
RECRUITING
Budapest
Synexus Magyarorszag Kft
COMPLETED
Budapest
Uno Medical Trials Ltd.
RECRUITING
Budapest
University of Debrecen
RECRUITING
Debrecen
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
RECRUITING
Gyula
Obudai Egeszsegugyi Centrum Kft
RECRUITING
Kaposvár
University of Szeged
RECRUITING
Szeged
MAV Korhaz es Rendelointezet
RECRUITING
Szolnok
Vital Medical Center Orvosi es Fogaszati Kozpont
RECRUITING
Veszprém
India
Marengo Cims Hospital
RECRUITING
Ahmedabad
Apollo Hospitals
RECRUITING
Bhubaneswar
Nizams Institute of Medical Sciences
RECRUITING
Hyderabad
Apollo Multispeciality Hospital Ltd
RECRUITING
Kolkata
Kokilaben Dhirubhai Ambani Hsp And Med Research Inst
RECRUITING
Mumbai
JSS Hospital
RECRUITING
Mysuru
All India Institute of Medical Sciences
RECRUITING
New Delhi
Indraprastha Apollo Hospital
RECRUITING
New Delhi
Fortis Hospital
RECRUITING
Noida
SIDS Hospital & Research Centre
RECRUITING
Surat
Japan
Fukuoka University Hospital
RECRUITING
Fukuoka
Teikyo University Hospital
RECRUITING
Itabashi Ku
Kagawa University Hospital
RECRUITING
Kita Gun
Nagoya City University Hospital
RECRUITING
Nagoya
Maeshima Rheumatology Clinic
RECRUITING
Ōita
Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
RECRUITING
Osaka
Sasebo Chuo Hospital
RECRUITING
Sasebo
Tohoku University Hospital
RECRUITING
Sendai
Kyorin University Hospital
RECRUITING
Tokyo
Mie University Hospital
RECRUITING
Tsu
Poland
ClinicMed Daniluk Nowak Spolka Komandytowa
RECRUITING
Bialystok
Osteo Medic S C Artur Racewicz Jerzy Supronik
RECRUITING
Bialystok
Specderm Poznanska sp j
COMPLETED
Bialystok
Szpital Uniwersytecki Nr 2 w Bydgoszczy
RECRUITING
Bydgoszcz
Ambulatorium sp. z o.o.
RECRUITING
Elblag
Centrum Kliniczno Badawcze
RECRUITING
Elblag
Centrum Medyczne Pratia Gdynia
RECRUITING
Gdynia
Centrum Medyczne All Med
RECRUITING
Krakow
Malopolskie Badania Kliniczne Sp z o o
RECRUITING
Krakow
Pratia MCM Krakow
RECRUITING
Krakow
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
RECRUITING
Krakow
Dermed Centrum Medyczne Sp z o o
RECRUITING
Lodz
Zespol Poradni Specjalistycznych Reumed Filia nr 1
RECRUITING
Lublin
NZOZ Lecznica MAK MED S C
RECRUITING
Nadarzyn
Etyka Osrodek Badan Klinicznych
RECRUITING
Olsztyn
MICS Centrum Medyczne Torun
RECRUITING
Torun
Centrum Medyczne Reuma Park
RECRUITING
Warsaw
MICS Centrum Medyczne Warszawa
RECRUITING
Warsaw
Centrum Medyczne Oporow
RECRUITING
Wroclaw
DermMedica Sp z o o
RECRUITING
Wroclaw
Spain
Hosp Univ A Coruna
RECRUITING
A Coruña
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. Clinic de Barcelona
RECRUITING
Barcelona
Hosp Reina Sofia
RECRUITING
Córdoba
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp Regional Univ de Malaga
RECRUITING
Málaga
Corporacio Sanitari Parc Tauli
RECRUITING
Sabadell
Hosp. Univ. Marques de Valdecilla
RECRUITING
Santander
Hosp. Infanta Luisa
RECRUITING
Seville
Hosp. Quiron Sagrado Corazon
RECRUITING
Seville
Hosp. Virgen Del Rocio
RECRUITING
Seville
Hosp. Virgen Macarena
RECRUITING
Seville
Taiwan
Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Chi Mei Medical Center Yong Kang
RECRUITING
Tainan
National Cheng Kung University Hospital
RECRUITING
Tainan
Taipei Veterans General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
National Taiwan University Hospital Hsin Chu Branch
RECRUITING
Taoyuan District
Thailand
Phramongkutklao Hospital
RECRUITING
Bangkok
Rajavithi Hospital
RECRUITING
Bangkok
Siriraj Hospital
RECRUITING
Bangkok
Saraburi Hospital
RECRUITING
Changwat Sara Buri
Phra Nakhon Si Ayutthaya Hospital
RECRUITING
Phra Nakhon Si Ayutthaya
Songklanagarind hospital
RECRUITING
Songkhla
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-02-21
Estimated Completion Date: 2028-11-21
Participants
Target number of participants: 540
Treatments
Experimental: Group I: Icotrokinra Dose 1
Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
Experimental: Group II: Icotrokinra Dose 2
Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2.
Placebo_comparator: Group III: Placebo
Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
Active_comparator: Group IV: Active Reference Comparator
Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov