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Badanie w celu oceny skuteczności i bezpieczeństwa Icotrokinra (JNJ-77242113) u uczestników z aktywnym łuszczycowym zapaleniem staw (ICONIC-PsA 2)

2 listopada 2026 zaktualizowane przez: Janssen Research & Development, LLC

Faza 3, wieloośrodkowa, randomizowana, podwójnie ślepa, kontrolowane placebo badanie oceniające skuteczność i bezpieczeństwo JNJ-77242113 w leczeniu uczestników doświadczonych biologicznie z aktywnym łuszczycowym zapaleniem stawów

The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

813

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • Buenos Aires, Argentyna, B1643CRO
        • Instituto Medico De Alta Complejidad (IMAC)
      • Buenos Aires, Argentyna, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • Buenos Aires, Argentyna, C1426
        • Hospital Militar Central Cir. My. Dr. Cosme Argerich
      • Ciudad de Buenos Aires, Argentyna, C1431
        • Arsema
      • Ciudad de San Miguel de Tucuman, Argentyna, T4000AXL
        • Centro Medico Privado de Reumatologia Tucuman
      • San Fernando, Argentyna, B1646GHP
        • MR Medicina Reumatologica
  • Australia
      • Ipswich, Australia, 4305
        • Ipswich Hospital
      • Maroochydore, Australia, 4558
        • Rheumatology Research Unit
      • South Woodville, Australia, 5011
        • Queen Elizabeth Hospital
      • St Leonards, Australia, 2065
        • Royal North Shore Hospital
      • Tiwi, Australia, 0810
        • Royal Darwin Hospital
  • Brazylia
      • Belo Horizonte, Brazylia, 30130 100
        • Faculdade de Medicina Universidade Federal de Minas Gerais
      • Porto Alegre, Brazylia, 90480 000
        • LMK Servicos Medicos S S
      • São José do Rio Preto, Brazylia, 15090-000
        • Funfarme Sjrp
      • São Paulo, Brazylia, 05403 900
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • São Paulo, Brazylia, 01236030
        • BR Trials
      • São Paulo, Brazylia, 04266 010
        • CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
  • Bułgaria
      • Plovdiv, Bułgaria, 4003
        • Multiprofile Hospital for Active Treatment Plovdiv
      • Plovdiv, Bułgaria, 4001
        • UMHAT Kaspela
      • Sliven, Bułgaria, 8801
        • Diagnostic Consulting Center I Sliven
      • Sofia, Bułgaria, 1431
        • Diagnostic-Consultative Center (DCC) Aleksandrovska
      • Sofia, Bułgaria, 1336
        • Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
      • Sofia, Bułgaria, 1612
        • UMHAT St. Ivan Rilski
      • Sofia, Bułgaria, 1750
        • ASIMP Rheumatology Centre St Irina EOOD
      • Sofia, Bułgaria, 1407
        • MC Ekselsior
  • Chiny
      • Beijing, Chiny, 100083
        • Peking University Third Hospital
      • Beijing, Chiny, 100730
        • Beijing Tong Ren Hospital Capital Medical University
      • Changchun, Chiny, 130021
        • The First Bethune Hospital of Jilin University
      • Changsha, Chiny, 410008
        • Xiangya Hospital Central South University
      • Chengdu, Chiny, 610041
        • West China Hospital Sichuan University
      • Chengdu, Chiny, 610072
        • Sichuan Provincial Peoples Hospital
      • Chongqing, Chiny, 400016
        • The First Affiliated Hospital of Chongqing Medical University
      • Dongguan, Chiny, 523109
        • Dongguan People s Hospital
      • Guangzhou, Chiny, 510515
        • Nanfang Hospital of Southern Medical Hospital
      • Guiyang, Chiny, 550004
        • The Affiliated Hospital of Guizhou Medical University
      • Hangzhou, Chiny, 310018
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Jiaxing, Chiny, 314001
        • The First Hospital of Jiaxing
      • Jinhua, Chiny, 321000
        • Jinhua municipal central hospital
      • Linfen, Chiny, 041000
        • Linfen Central Hospital
      • Linyi, Chiny, 276002
        • Linyi City People Hospital
      • Nanchang, Chiny, 330008
        • The Second Affiliated Hospital of Nanchang University
      • Nantong, Chiny, 226001
        • Affiliated Hospital of Nantong University
      • Pingxiang, Chiny, 337055
        • Pingxiang People's Hospital
      • Shanghai, Chiny, 200040
        • Huashan Hospital Fudan University
      • Shanghai, Chiny, 200443
        • Shanghai skin disease hospital
      • Shenzhen, Chiny, 518020
        • Shenzhen People s Hospital
      • Suzhou, Chiny, 215004
        • Second Affiliated Hospital of Soochow University
      • Taiyuan, Chiny, 030032
        • Shanxi Bethune Hospital
      • Wenzhou, Chiny, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
      • Xi'an, Chiny, 710006
        • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Czechy
      • Brno, Czechy, 63800
        • Revmatologie s r o
      • Brno, Czechy, 615 00
        • Revmacentrum MUDr Mostera s r o
      • Břeclav, Czechy, 690 02
        • RHEUMA s r o
      • Hlučín, Czechy, 748 01
        • L K N Arthrocentrum
      • Ostrava, Czechy, 70200
        • CCR Ostrava S R O
      • Ostrava, Czechy, 708 00
        • MUDr Rosypalova s r o
      • Prague, Czechy, 13000
        • Pratia Czech s r o
      • Prague, Czechy, 15000
        • FN Motol
      • Uherské Hradiště, Czechy, 68601
        • Medical Plus S R O
      • Zlín, Czechy, 76001
        • PV Medical S R O
  • Dania
      • Aarhus N, Dania, 8200
        • Aarhus University Hospital
      • Esbjerg, Dania, 6700
        • Sydvestjysk Sygehus
      • Frederiksberg, Dania, 2000
        • Frederiksberg Hospital
      • Herning, Dania, 7400
        • Regionshospitalet Godstrup
      • Svendborg, Dania, 5700
        • Svendborg Hospital Odense University Hospital
      • Vejle, Dania, 7100
        • Vejle Sygehus
  • Hiszpania
      • A Coruña, Hiszpania, 15006
        • Hosp Univ A Coruna
      • Córdoba, Hiszpania, 14004
        • Hosp Reina Sofia
      • L'Hospitalet de Llobregat, Hiszpania, 08907
        • Hosp. Univ. de Bellvitge
      • Madrid, Hiszpania, 28031
        • Hosp. Univ. Infanta Leonor
      • Málaga, Hiszpania, 29009
        • Hosp Regional Univ de Malaga
      • Santander, Hiszpania, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Santiago de Compostela, Hiszpania, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Hiszpania, 41013
        • Hosp. Virgen Del Rocio
      • Seville, Hiszpania, 41009
        • Hosp. Virgen Macarena
      • Seville, Hiszpania, 41014
        • Hosp. Ntra. Sra. de Valme
      • Seville, Hiszpania, 41010
        • Hosp. Infanta Luisa
  • Hongkong
      • Hong Kong, Hongkong
        • Queen Mary Hospital
      • Hong Kong, Hongkong, 000000
        • Prince of Wales Hospital
  • Indie
      • Ahmedabad, Indie, 380060
        • Marengo Cims Hospital
      • Bhubaneswar, Indie, 751005
        • Apollo Hospitals
      • Hubballi, Indie, 580021
        • Sushruta Multispeciality Hospital
      • Kolkata, Indie, 700054
        • Apollo Multispeciality Hospital Ltd
      • Mysuru, Indie, 570004
        • JSS Hospital
      • New Delhi, Indie, 110029
        • All India Institute of Medical Sciences
      • New Delhi, Indie, 1100776
        • Indraprastha Apollo Hospital
      • Noida, Indie, 201301
        • Fortis Hospital
      • Surat, Indie, 395002
        • SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
  • Japonia
      • Chiba, Japonia, 260-8712
        • NHO Chiba Medical Center Chibahigashi National Hospital
      • Chūōku, Japonia, 104 8560
        • St. Luke's International Hospital
      • Hirakata, Japonia, 573 1191
        • Kansai Medical University Hospital
      • Hyōgo, Japonia, 6751392
        • Kita-harima Medical Center
      • Kitakyushu-shi, Japonia, 807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Nagoya, Japonia, 467 8602
        • Nagoya City University Hospital
      • Osaka, Japonia, 550 0006
        • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
      • Osaka, Japonia, 545 8586
        • Osaka Metropolitan University Hospital
      • Sanuki, Japonia, 7692393
        • Sanuki Municipal Hospital
      • Sasebo, Japonia, 857 1195
        • Sasebo Chuo Hospital
      • Sendai, Japonia, 980 8574
        • Tohoku University Hospital
      • Shimotsuga Gun, Japonia, 321 0293
        • Dokkyo Medical University Hospital
      • Tokyo, Japonia, 181 8611
        • Kyorin University Hospital
      • Tsu, Japonia, 514 8507
        • Mie University Hospital
      • Yokohama, Japonia, 245-8575
        • National Hospital Organization Yokohama Medical Center
      • Ōita, Japonia, 870 0030
        • Maeshima Rheumatology Clinic
  • Kanada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1C 5B8
        • Eastern Regional Health Authority St Clares Mercy Hospital
    • Ontario
      • Orillia, Ontario, Kanada, L3V 1T5
        • The Waterside Clinic
      • Toronto, Ontario, Kanada, M5S 1B1
        • Womens College Hospital
      • Waterloo, Ontario, Kanada, N2J 1C4
        • Alliance Clinical Trials
      • Windsor, Ontario, Kanada, N8X 1T3
        • Dr Sabeen Anwar Medicine Professional Corporation
    • Quebec
      • Montreal, Quebec, Kanada, H1T 2M4
        • Hospital Maisonneuve-Rosemont
      • Trois-Rivières, Quebec, Kanada, G9A 3X2
        • Centre de Recherche Musculo Squelettique
  • Malezja
      • Alor Star, Malezja, 05460
        • Hospital Sultanah Bahiyah
      • Batu Caves, Malezja, 68100
        • Hospital Selayang
      • Ipoh, Malezja, 30450
        • Hospital Raja Permaisuri Bainun
      • Johor Bahru, Malezja, 81100
        • Hospital Sultan Ismail
      • Kuala Lumpur, Malezja, 50586
        • Hospital Kuala Lumpur
      • Seremban, Malezja, 70300
        • Hospital Tuanku Jaafar
  • Meksyk
      • Culiacán, Meksyk, 80000
        • Centro de Investigacion de Tratamientos Innovadores de Sinaloa
      • Guadalajara, Meksyk, 44630
        • Grupo Clinico CATEI
      • Mexicali, Meksyk, 45116
        • Centro Medico del Angel
      • Mexico City, Meksyk, 03100
        • RM Pharma Specialists
      • Monterrey, Meksyk, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
      • San Luis Potosí City, Meksyk, 78213
        • Centro de Alta Especialidad en Reumatologia e Investigacion
  • Niemcy
      • Berlin, Niemcy, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Berlin, Niemcy, 10117
        • Charite - Campus Mitte
      • Cologne, Niemcy, 51149
        • Krankenhaus Porz am Rhein
      • Dresden, Niemcy, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Freiburg im Breisgau, Niemcy, 79106
        • Medizinische Fakultaet Der Albert Ludwigs Universitaet Freiburg
      • Hamburg, Niemcy, 20095
        • Hamburger Rheuma Forschungszentrum II
      • Herne, Niemcy, 44649
        • Rheumazentrum Ruhrgebiet
      • Langenau, Niemcy, 89129
        • Praxis Dr. med. Beate Schwarz - Germany
      • Ratingen, Niemcy, 40878
        • Rheumaforschung - Studienambulanz Dr. Wassenberg
      • Tübingen, Niemcy, 72076
        • Universitatsklinikum Tubingen
  • Polska
      • Bialystok, Polska, 15-879
        • ClinicMed Daniluk Nowak Spolka Komandytowa
      • Bialystok, Polska, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, Polska, 15-375
        • Specderm Poznanska sp j
      • Bydgoszcz, Polska, 85-168
        • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
      • Elblag, Polska, 82-300
        • Centrum Kliniczno Badawcze
      • Elblag, Polska, 82-300
        • Ambulatorium sp. z o.o.
      • Gdynia, Polska, 81-338
        • Centrum Medyczne Pratia Gdynia
      • Krakow, Polska, 30-727
        • Pratia MCM Krakow
      • Krakow, Polska, 30-002
        • Malopolskie Badania Kliniczne Sp z o o
      • Krakow, Polska, 30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Krakow, Polska, 30-033
        • Centrum Medyczne All Med
      • Lodz, Polska, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Lublin, Polska, 20-607
        • Zespol Poradni Specjalistycznych Reumed Filia nr 1
      • Nadarzyn, Polska, 05-830
        • NZOZ Lecznica MAK MED S C
      • Torun, Polska, 87-100
        • MICS Centrum Medyczne Torun
      • Warsaw, Polska, 00-874
        • MICS Centrum Medyczne Warszawa
      • Warsaw, Polska, 02-665
        • Centrum Medyczne Reuma Park
      • Wroclaw, Polska, 52-416
        • Centrum Medyczne Oporow
      • Wroclaw, Polska, 51-503
        • DermMedica Sp z o o
  • Rumunia
      • Bucharest, Rumunia, 014142
        • S C Delta Health Care S R L
      • Bucharest, Rumunia, 012071
        • Quantum Medical Center Srl
      • Bucharest, Rumunia, 030463
        • CCBR Clinical Research
      • Bucharest, Rumunia, 041312
        • Hiperdia Piata Sudului
      • Craiova, Rumunia, 200400
        • Ecomed Research SRL
      • Iași, Rumunia, 700259
        • Centrul Medical Unirea
      • Râmnicu Vâlcea, Rumunia, 247065
        • Medaudio Optica S R L
  • Stany Zjednoczone
    • Arizona
      • Glendale, Arizona, Stany Zjednoczone, 85306
        • AARA Clinical Research
      • Mesa, Arizona, Stany Zjednoczone, 85210
        • AARA Clinical Research 1
    • Arkansas
      • Jonesboro, Arkansas, Stany Zjednoczone, 72401
        • Arthritis and Rheumatism Associates ARA Jonesboro
    • Florida
      • Clearwater, Florida, Stany Zjednoczone, 33765
        • Clinical Research of West Florida
      • DeBary, Florida, Stany Zjednoczone, 32713
        • Omega Research Consultants
      • New Port Richey, Florida, Stany Zjednoczone, 34652
        • Suncoast Clinical Research
      • Plantation, Florida, Stany Zjednoczone, 33324
        • Integral Rheumatology And Immunology Specialists
      • Tampa, Florida, Stany Zjednoczone, 33606
        • Clinical Research of West Florida 1
    • Illinois
      • Skokie, Illinois, Stany Zjednoczone, 60076
        • Clinic of Robert Hozman
    • Maryland
      • Hagerstown, Maryland, Stany Zjednoczone, 21740
        • Klein And Associates M D P A
    • Massachusetts
      • Brookline, Massachusetts, Stany Zjednoczone, 02446
        • DM Clinical Research 1
    • Minnesota
      • Eagan, Minnesota, Stany Zjednoczone, 55123
        • St Paul Rheumatology PA
    • New Mexico
      • Albuquerque, New Mexico, Stany Zjednoczone, 87102
        • Albuquerque Rehabilitation and Rheumatology
    • North Carolina
      • Charlotte, North Carolina, Stany Zjednoczone, 28204
        • Joint and Muscle Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73116
        • Rheumatology Associates of Oklahoma
    • Pennsylvania
      • Duncansville, Pennsylvania, Stany Zjednoczone, 16635
        • Altoona Center For Clinical Research
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19114
        • Clinical Research Philadelphia
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75390
        • UT Southwestern
      • Frisco, Texas, Stany Zjednoczone, 75035
        • Arthritis and Rheumatology Research Institute
      • Harlingen, Texas, Stany Zjednoczone, 78550
        • Naiara Alvarez MD Integrative Rheumatology of South TX
      • Irving, Texas, Stany Zjednoczone, 75039
        • AARA Clinical Research Lone Star Arthritis and Rheumatology
      • Tomball, Texas, Stany Zjednoczone, 77375
        • DM Clinical Research
      • Waco, Texas, Stany Zjednoczone, 76710
        • Velocity Clinical Research
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98104
        • Seattle Rheumatology
    • Wisconsin
      • Glendale, Wisconsin, Stany Zjednoczone, 53217
        • Center of Rheumatic Diseases
  • Tajlandia
      • Bangkok, Tajlandia, 10400
        • Phramongkutklao Hospital
      • Bangkok, Tajlandia, 10700
        • Siriraj Hospital
      • Bangkok, Tajlandia, 10400
        • Rajavithi Hospital
      • Changwat Sara Buri, Tajlandia, 18000
        • Saraburi Hospital
      • Songkhla, Tajlandia, 90110
        • Songklanagarind hospital
  • Tajwan
      • Hsinchu, Tajwan, 300
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, Tajwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan, Tajwan, 710
        • Chi Mei Medical Center
      • Taipei, Tajwan, 112
        • Taipei Veterans General Hospital
  • Turcja (Türkiye)
      • Ankara, Turcja (Türkiye), 06010
        • Gulhane Egitim ve Arastirma Hastanesi
      • Ankara, Turcja (Türkiye), 06570
        • Gazi Universitesi Tip Fakultesi
      • Gaziantep, Turcja (Türkiye), 27090
        • Sanko Universitesi Hastanesi
      • Istanbul, Turcja (Türkiye), 34899
        • Marmara University Medical Faculty
      • Kocaeli, Turcja (Türkiye), 41001
        • Kocaeli University Medical Faculty
      • Konya, Turcja (Türkiye), 42080
        • Necmettin Erbakan Universitesi Tip Fakultesi
  • Węgry
      • Budapest, Węgry, 1152
        • Uno Medical Trials Ltd.
      • Budapest, Węgry, 1023
        • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
      • Budapest, Węgry, 1027
        • Revita Kft
      • Budapest, Węgry, 1134
        • Qualiclinic Kft
      • Békéscsaba, Węgry, 5600
        • Trial Pharma Kft
      • Debrecen, Węgry, 4032
        • Debreceni Egyetem Reumatologiai Klinika
      • Gyula, Węgry, 5700
        • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Hódmezővásárhely, Węgry, 6800
        • Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
      • Kaposvár, Węgry, 7400
        • Obudai Egeszsegugyi Centrum Kft
      • Kecskemét, Węgry, 6000
        • Bacs Kiskun Varmegyei Oktatokorhaz
      • Szeged, Węgry, 6725
        • University of Szeged
      • Szolnok, Węgry, 5000
        • MAV Korhaz es Rendelointezet
      • Székesfehérvár, Węgry, 8000
        • Complex Rendelo Med Zrt
      • Székesfehérvár, Węgry, 8000
        • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
      • Veszprém, Węgry, 8200
        • Vital Medical Center Orvosi es Fogaszati Kozpont
  • Włochy
      • Ancona, Włochy, 60126
        • A.O. Universitaria Ospedali Riuniti di Ancona
      • Brescia, Włochy, 25123
        • ASST Spedali Civili Brescia
      • Catania, Włochy, 95124
        • Policlinico San Marco
      • Milan, Włochy, 20132
        • Ospedale San Raffaele
      • Naples, Włochy, 80138
        • Azienda Ospedaliero Universitaria Luigi Vanvitelli
      • Pavia, Włochy, 27100
        • IRCCS Policlinico San Matteo
      • Roma, Włochy, 00133
        • Universita Degli Studi di Roma Tor Vergata
      • Roma, Włochy, 00168
        • Fondazione Policlinico Universitario A Gemelli IRCCS
      • Rozzano, Włochy, 20089
        • Istituto Clinico Humanitas
      • Siena, Włochy, 53100
        • A O Universitaria Senese Ospedale Santa Maria alle Scotte
      • Udine, Włochy, 33100
        • Ospedale S. Maria Della Misericordia
  • Zjednoczone Królestwo
      • Barnet, Zjednoczone Królestwo, EN5 3DJ
        • Royal Free London NHS Foundation Trust
      • Basingstoke, Zjednoczone Królestwo, RG24 9NA
        • Basingstoke And North Hampshire Hospital
      • Christchurch, Zjednoczone Królestwo, BH23 2JX
        • University Hospitals Dorset NHS Foundation Trust
      • Edinburgh, Zjednoczone Królestwo, EH4 2XU
        • Western General Hospital
      • Glasgow, Zjednoczone Królestwo, G31 2ER
        • Glasgow Royal Infirmary
      • Hereford, Zjednoczone Królestwo, HR1 2ER
        • Hereford County Hospital
      • Larbert, Zjednoczone Królestwo, FK5 4WR
        • Forth Valley Royal Hospital
      • Staffordshire, Zjednoczone Królestwo, ST6 7AG
        • Haywood Hospital
      • Torquay, Zjednoczone Królestwo, TQ2 7AA
        • Torbay Hospital-Devon
      • Wolverhampton, Zjednoczone Królestwo, WV10 0QP
        • New Cross Hospital
      • Wrexham, Zjednoczone Królestwo, LL13 7TD
        • Betsi Cadwaladr University Health Board BCUHB

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (>=) 1 of the following: a. Non-biologic disease-modifying antirheumatic drug (DMARD) therapy; b. Apremilast therapy; c. Biologic-agent (limited to only 1)
  • Have a diagnosis of 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) >= 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

Exclusion Criteria:

  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
  • Currently has a malignancy or has a history of malignancy within 5 years prior to screening
  • Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
  • Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or Lyme disease
  • Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Icotrokinra

Icotrokinra will be administered.

Inne nazwy:
  • JNJ-77242113
Eksperymentalny: 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.
Lek: Icotrokinra

Icotrokinra will be administered.

Inne nazwy:
  • JNJ-77242113
Komparator placebo: 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.
Lek: Placebo

Placebo will be administered.

Lek: Icotrokinra

Icotrokinra will be administered.

Inne nazwy:
  • JNJ-77242113

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
Ramy czasowe: Week 16

The ACR 20 responders are participants with an improvement of greater than or equal to (>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity [arthritis, VAS] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).
Week 16

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and With Baseline IGA Score of >=2
Ramy czasowe: Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Week 16
Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
Ramy czasowe: Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Week 16
Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
Ramy czasowe: Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score.
Week 16
Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
Ramy czasowe: Week 16

Proportion of participants with an IGA psoriasis score of 0 or 1 And >=2 grade improvement from baseline at Week 16 among participants with >=3% BSA and an IGA Score of >=2 at Baseline will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling, each using a 5-point scale: using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema, and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 16
Proportion of Participants who Achieved an ACR 50 Response at Week 16
Ramy czasowe: Week 16

The ACR 50 responders are participants with an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity (arthritis, VAS) scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).
Week 16
Proportion of Participants who Achieved an ACR 70 Response at Week 16
Ramy czasowe: Week 16

The ACR 70 responders are participants with an improvement of >= 70% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity (arthritis, VAS) scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
Week 16
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16
Ramy czasowe: From baseline up to Week 16

The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
From baseline up to Week 16
Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Ramy czasowe: From baseline up to Week 16

SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0 to 100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
From baseline up to Week 16
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline
Ramy czasowe: Week 16

Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Week 16
Change From Baseline in Enthesitis Score at Week 16 in Participants With Enthesitis at Baseline
Ramy czasowe: Baseline and Week 16

Enthesitis will be assessed using the LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Baseline and Week 16
Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline
Ramy czasowe: Week 16

Dactylitis is characterized by swelling of the entire finger or toe. Presence and severity of dactylitis will be assessed in both hand and feet using a scoring system from 0 to 3 (0: no dactylitis, 1: mild dactylitis, 2: moderate dactylitis, 3: severe dactylitis). The result for each digit are summed to produce a final dactylitis score with a range from 0 to 60. Higher score indicates greater severity.
Week 16
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline
Ramy czasowe: From baseline up to Week 16

Dactylitis is characterized by swelling of the entire finger or toe. Presence and severity of dactylitis will be assessed in both hand and feet using a scoring system from 0 to 3 (0: no dactylitis, 1: mild dactylitis, 2: moderate dactylitis, 3: severe dactylitis). The result for each digit are summed to produce a final dactylitis score with a range from 0 to 60. Change from baseline in dactylitis score measure the change in dactylitis, where a negative change indicates an improvement and a positive change indicates a worsening.
From baseline up to Week 16
Proportion of Participants who Achieved Minimal Disease Activity (MDA) at Week 16
Ramy czasowe: Week 16

MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill at least 5 out of the 7 outcome measures: tender joint count less than or equal to (<=) 1; swollen joint count <= 1; psoriasis activity and severity index <= 1 or body surface area <= 3 percent (%); patient pain VAS score of <= 15; patient global disease activity VAS (arthritis and psoriasis) score of <= 20; health assessment questionnaire (HAQ) score <= 0.5; and tender entheseal points <= 1.
Week 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16
Ramy czasowe: From baseline up to Week 16

The FACIT-fatigue is a self-administered, 13 item questionnaire measuring items on tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responses to all items are rated on a 5-point Likert response scale ranging from 0 "not at all" to 4 "very much." The total score ranges from 0 to 52, with higher values indicating less fatigue.
From baseline up to Week 16

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Janssen Research & Development, LLC

Śledczy

  • Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

9 stycznia 2025

Zakończenie podstawowe (Szacowany)

10 lutego 2027

Ukończenie studiów (Szacowany)

18 października 2028

Daty rejestracji na studia

Pierwszy przesłany

29 stycznia 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 stycznia 2025

Pierwszy wysłany (Rzeczywisty)

4 lutego 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 77242113PSA3002
  • 2024-517284-23-00 (Identyfikator rejestru: EUCT number)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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