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

Status: Recruiting
Location: See all (204) 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 biologic-experienced 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:

• Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and have discontinued treatment for any reason. The reason for discontinuation must be documented

• 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
Arizona
AARA Clinical Research
RECRUITING
Glendale
AARA Clinical Research
RECRUITING
Mesa
Florida
Clinical Research of West Florida
RECRUITING
Clearwater
Omega Research Consultants
RECRUITING
Debary
Suncoast Clinical Research
RECRUITING
New Port Richey
Integral Rheumatology And Immunology Specialists
RECRUITING
Plantation
Clinical Research of West Florida
RECRUITING
Tampa
Illinois
Clinic of Robert Hozman
RECRUITING
Skokie
Massachusetts
DM Clinical Research
RECRUITING
Brookline
Maryland
Klein And Associates M D P A
RECRUITING
Hagerstown
Minnesota
St Paul Rheumatology PA
RECRUITING
Eagan
North Carolina
Joint and Muscle Research Institute
RECRUITING
Charlotte
New Mexico
Albuquerque Rehabilitation and Rheumatology
RECRUITING
Albuquerque
Oklahoma
Rheumatology Associates of Oklahoma
RECRUITING
Oklahoma City
Pennsylvania
Altoona Center For Clinical Research
RECRUITING
Duncansville
Texas
Arthritis and Rheumatology Research Institute
RECRUITING
Allen
UT Southwestern
RECRUITING
Dallas
Naiara Alvarez MD Integrative Rheumatology of South TX
RECRUITING
Harlingen
AARA Clinical Research Lone Star Arthritis and Rheumatology
RECRUITING
Irving
DM Clinical Research
RECRUITING
Tomball
Velocity Clinical Research
RECRUITING
Waco
Washington
Seattle Rheumatology
RECRUITING
Seattle
Other Locations
Argentina
ARCIS Salud SRL Aprillus asistencia e investigacion
RECRUITING
Buenos Aires
Hospital Militar Central Cir. My. Dr. Cosme Argerich
RECRUITING
Buenos Aires
Instituto Medico De Alta Complejidad (IMAC)
RECRUITING
Buenos Aires
Arsema
RECRUITING
Ciudad De Buenos Aires
Centro Medico Privado de Reumatologia Tucuman
RECRUITING
Ciudad De San Miguel De Tucuman
MR Medicina Reumatologica
RECRUITING
San Fernando
Australia
Ipswich Hospital
RECRUITING
Ipswich
Rheumatology Research Unit
RECRUITING
Maroochydore
Queen Elizabeth Hospital
RECRUITING
South Woodville
Royal North Shore Hospital
RECRUITING
St Leonards
Royal Darwin Hospital
RECRUITING
Tiwi
Brazil
Universidade Federal de Minas Gerais UFMG Faculdade de Medicina
RECRUITING
Belo Horizonte
LMK Servicos Medicos S S
RECRUITING
Porto Alegre
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
RECRUITING
São José Do Rio Preto
BR TRIALS Ensaios Clinicos e Consultoria Ltda
RECRUITING
São Paulo
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
RECRUITING
São Paulo
Hospital Das Clinicas Da Faculdade De Medicina Da USP
RECRUITING
São Paulo
Bulgaria
Multiprofile Hospital for Active Treatment Plovdiv
RECRUITING
Plovdiv
UMHAT Kaspela
RECRUITING
Plovdiv
Diagnostic Consulting Center I Sliven
RECRUITING
Sliven
ASIMP Rheumatology Centre St Irina EOOD
RECRUITING
Sofia
Diagnostic-Consultative Center (DCC) Aleksandrovska
RECRUITING
Sofia
MC Ekselsior
RECRUITING
Sofia
Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
RECRUITING
Sofia
UMHAT St. Ivan Rilski
RECRUITING
Sofia
Canada
Hospital Maisonneuve-Rosemont
RECRUITING
Montreal
The Waterside Clinic
RECRUITING
Orillia
Eastern Regional Health Authority St Clares Mercy Hospital
RECRUITING
St. John's
Womens College Hospital
RECRUITING
Toronto
Centre de Recherche Musculo Squelettique
RECRUITING
Trois-rivières
Alliance Clinical Trials
RECRUITING
Waterloo
Dr Sabeen Anwar Medicine Professional Corporation
RECRUITING
Windsor
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
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Hospital of Jiaxing
RECRUITING
Jiaxing
Jinhua municipal central hospital
RECRUITING
Jinhua
Linyi City People Hospital
RECRUITING
Linyi
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
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
Denmark
Aarhus University Hospital
RECRUITING
Aarhus N
Sydvestjysk Sygehus
RECRUITING
Esbjerg
Frederiksberg Hospital
RECRUITING
Frederiksberg
Regionshospitalet Godstrup
RECRUITING
Herning
Svendborg Hospital Odense University Hospital
RECRUITING
Svendborg
Vejle Sygehus
RECRUITING
Vejle
Germany
Charite - Campus Mitte
RECRUITING
Berlin
ISA - Interdisciplinary Study Association GmbH
RECRUITING
Berlin
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
RECRUITING
Dresden
Medizinische Fakultaet Der Albert Ludwigs Universitaet Freiburg
RECRUITING
Freiburg Im Breisgau
Hamburger Rheuma Forschungszentrum II
RECRUITING
Hamburg
Rheumazentrum Ruhrgebiet
RECRUITING
Herne
Praxis Dr. med. Beate Schwarz - Germany
RECRUITING
Langenau
Rheumaforschung - Studienambulanz Dr. Wassenberg
RECRUITING
Ratingen
Universitatsklinikum Tubingen
RECRUITING
Tübingen
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
Queen Mary Hospital
RECRUITING
Hong Kong
Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
RECRUITING
Budapest
Qualiclinic Kft
RECRUITING
Budapest
Revita Kft
RECRUITING
Budapest
Uno Medical Trials Ltd.
RECRUITING
Budapest
Debreceni Egyetem Reumatologiai Klinika
RECRUITING
Debrecen
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
RECRUITING
Gyula
Obudai Egeszsegugyi Centrum Kft
RECRUITING
Kaposvár
Bacs Kiskun Varmegyei Oktatokorhaz
RECRUITING
Kecskemét
University of Szeged
RECRUITING
Szeged
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
RECRUITING
Székesfehérvár
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
Sushruta Multispeciality Hospital
RECRUITING
Hubballi
Apollo Multispeciality Hospital Ltd
RECRUITING
Kolkata
JSS Hospital
RECRUITING
Mysuru
All India Institute of Medical Sciences
RECRUITING
New Delhi
Indraprastha Apollo Hospital
RECRUITING
New Delhi
Fortis Hospital
RECRUITING
Noida
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
RECRUITING
Surat
Italy
A.O. Universitaria Ospedali Riuniti di Ancona
RECRUITING
Ancona
ASST Spedali Civili Brescia
RECRUITING
Brescia
Policlinico San Marco
RECRUITING
Catania
Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliero Universitaria Luigi Vanvitelli
RECRUITING
Napoli
IRCCS Policlinico San Matteo
RECRUITING
Pavia
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Roma
Universita Degli Studi di Roma Tor Vergata
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
A O Universitaria Senese Ospedale Santa Maria alle Scotte
RECRUITING
Siena
Ospedale S. Maria Della Misericordia
RECRUITING
Udine
Japan
St. Luke's International Hospital
RECRUITING
Chūōku
Kansai Medical University Hospital
RECRUITING
Hirakata
Kita-harima Medical Center
COMPLETED
Hyōgo
Hospital of the University of Occupational and Enviromental Health
RECRUITING
Kitakyushu-shi
Nagoya City University Hospital
RECRUITING
Nagoya
Maeshima Rheumatology Clinic
RECRUITING
Ōita
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Sanuki Municipal Hospital
RECRUITING
Sanuki
Sasebo Chuo Hospital
RECRUITING
Sasebo
Tohoku University Hospital
RECRUITING
Sendai
Dokkyo Medical University Hospital
RECRUITING
Shimotsuga Gun
Kyorin University Hospital
RECRUITING
Tokyo
Mie University Hospital
RECRUITING
Tsu
Malaysia
Hospital Sultanah Bahiyah
RECRUITING
Alor Star
Hospital Selayang
RECRUITING
Batu Caves
Hospital Raja Permaisuri Bainun
RECRUITING
Ipoh
Hospital Sultan Ismail
RECRUITING
Johor Bahru
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
Hospital Tuanku Jaafar
RECRUITING
Seremban
Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa
RECRUITING
Culiacán
Grupo Clinico CATEI
RECRUITING
Guadalajara
Centro Medico del Angel
RECRUITING
Mexicali
RM Pharma Specialists
RECRUITING
Mexico City
Centro de Alta Especialidad en Reumatologia e Investigacion
RECRUITING
San Luis Potosí City
Poland
ClinicMed Daniluk Nowak Spolka Komandytowa
RECRUITING
Bialystok
Osteo-Medic s.c A. Racewicz, J 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
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
Romania
S C Delta Health Care S R L
RECRUITING
Bucharest
Ecomed Research SRL
RECRUITING
Craiova
Centrul Medical Unirea
RECRUITING
Iași
Medaudio Optica S R L
RECRUITING
Râmnicu Vâlcea
Spain
Hosp Univ A Coruna
RECRUITING
A Coruña
Hosp Reina Sofia
RECRUITING
Córdoba
Hosp. Univ. de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hosp. Univ. Infanta Leonor
RECRUITING
Madrid
Hosp Regional Univ de Malaga
RECRUITING
Málaga
Hosp. Univ. Marques de Valdecilla
RECRUITING
Santander
Hosp. Clinico Univ. de Santiago
RECRUITING
Santiago De Compostela
Hosp. Infanta Luisa
RECRUITING
Seville
Hosp. Virgen Del Rocio
RECRUITING
Seville
Hosp. Virgen Macarena
RECRUITING
Seville
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Chi Mei Medical Center
RECRUITING
Tainan
Taipei Veterans General Hospital
RECRUITING
Taipei
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
Songklanagarind hospital
RECRUITING
Songkhla
United Kingdom
Royal Free London NHS Foundation Trust
RECRUITING
Barnet
Basingstoke And North Hampshire Hospital
RECRUITING
Basingstoke
University Hospitals Dorset NHS Foundation Trust
RECRUITING
Christchurch
Glasgow Royal Infirmary
RECRUITING
Edinburgh
Western General Hospital
RECRUITING
Edinburgh
Hereford County Hospital
RECRUITING
Hereford
Forth Valley Royal Hospital
RECRUITING
Larbert
Haywood Hospital
RECRUITING
Staffordshire
Torbay Hospital-Devon
RECRUITING
Torquay
New Cross Hospital
RECRUITING
Wolverhampton
Betsi Cadwaladr University Health Board BCUHB
RECRUITING
Wrexham
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-01-09
Estimated Completion Date: 2028-10-18
Participants
Target number of participants: 750
Treatments
Experimental: Group I: Icotrokinra Dose 1
Participants will receive icotrokinra Dose 1. Participants who have not discontinued will be eligible to enter a long term extension (LTE) and will continue to receive icotrokinra Dose 1.
Experimental: Group II: Icotrokinra Dose 2
Participants will receive icotrokinra Dose 2. Participants who have not discontinued will be eligible to enter a LTE and 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 at Week 16. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 1 or Dose 2.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov