A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis
ICONIC-PsA 2
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis
2 other identifiers
interventional
750
23 countries
214
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2025
Typical duration for phase_3
214 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2025
CompletedFirst Submitted
Initial submission to the registry
January 29, 2025
CompletedFirst Posted
Study publicly available on registry
February 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 18, 2028
May 5, 2026
April 1, 2026
2.1 years
January 29, 2025
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at 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
Secondary Outcomes (14)
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
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
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
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
Week 16
Proportion of Participants who Achieved an ACR 50 Response at Week 16
Week 16
- +9 more secondary outcomes
Study Arms (3)
Group I: Icotrokinra Dose 1
EXPERIMENTALParticipants 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.
Group II: Icotrokinra Dose 2
EXPERIMENTALParticipants 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.
Group III: Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Icotrokinra will be administered.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (214)
AARA Clinical Research
Glendale, Arizona, 85306, United States
AARA Clinical Research 1
Mesa, Arizona, 85210, United States
Arthritis and Rheumatism Associates ARA Jonesboro
Jonesboro, Arkansas, 72401, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Omega Research Consultants
DeBary, Florida, 32713, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Integral Rheumatology And Immunology Specialists
Plantation, Florida, 33324, United States
Clinical Research of West Florida 1
Tampa, Florida, 33606, United States
Clinic of Robert Hozman
Skokie, Illinois, 60076, United States
Klein And Associates M D P A
Hagerstown, Maryland, 21740, United States
DM Clinical Research 1
Brookline, Massachusetts, 02446, United States
St Paul Rheumatology PA
Eagan, Minnesota, 55123, United States
Albuquerque Rehabilitation and Rheumatology
Albuquerque, New Mexico, 87102, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204, United States
Rheumatology Associates of Oklahoma
Oklahoma City, Oklahoma, 73116, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Arthritis and Rheumatology Research Institute
Allen, Texas, 75013, United States
UT Southwestern
Dallas, Texas, 75390, United States
Naiara Alvarez MD Integrative Rheumatology of South TX
Harlingen, Texas, 78550, United States
AARA Clinical Research Lone Star Arthritis and Rheumatology
Irving, Texas, 75039, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Velocity Clinical Research
Waco, Texas, 76710, United States
Seattle Rheumatology
Seattle, Washington, 98104, United States
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, B1643CRO, Argentina
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires, C1406AGA, Argentina
Hospital Militar Central Cir. My. Dr. Cosme Argerich
Buenos Aires, C1426, Argentina
Arsema
Ciudad de Buenos Aires, C1431, Argentina
Centro Medico Privado de Reumatologia Tucuman
Ciudad de San Miguel de Tucuman, T4000AXL, Argentina
MR Medicina Reumatologica
San Fernando, B1646GHP, Argentina
Ipswich Hospital
Ipswich, 4305, Australia
Rheumatology Research Unit
Maroochydore, 4558, Australia
Queen Elizabeth Hospital
South Woodville, 5011, Australia
Royal North Shore Hospital
St Leonards, 2065, Australia
Royal Darwin Hospital
Tiwi, 0810, Australia
Universidade Federal de Minas Gerais UFMG Faculdade de Medicina
Belo Horizonte, 30130 100, Brazil
LMK Servicos Medicos S S
Porto Alegre, 90480 000, Brazil
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
São José do Rio Preto, 15090-000, Brazil
BR TRIALS Ensaios Clinicos e Consultoria Ltda
São Paulo, 01236030, Brazil
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
São Paulo, 04266 010, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403 900, Brazil
UMHAT Kaspela
Plovdiv, 4001, Bulgaria
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, 4003, Bulgaria
Diagnostic Consulting Center I Sliven
Sliven, 8801, Bulgaria
Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
Sofia, 1336, Bulgaria
MC Ekselsior
Sofia, 1407, Bulgaria
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, 1431, Bulgaria
UMHAT St. Ivan Rilski
Sofia, 1612, Bulgaria
ASIMP Rheumatology Centre St Irina EOOD
Sofia, 1750, Bulgaria
Eastern Regional Health Authority St Clares Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
The Waterside Clinic
Orillia, Ontario, L3V 1T5, Canada
Womens College Hospital
Toronto, Ontario, M5S 1B1, Canada
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4, Canada
Dr Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, N8X 1T3, Canada
Hospital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Centre de Recherche Musculo Squelettique
Trois-Rivières, Quebec, G9A 3X2, Canada
Peking University Third Hospital
Beijing, 100191, China
Beijing Tong Ren Hospital Capital Medical University
Beijing, 100730, China
The First Bethune Hospital of Jilin University
Changchun, 130021, China
Xiangya Hospital Central South University
Changsha, 410008, China
West China Hospital Sichuan University
Chengdu, 610041, China
Sichuan Provincial Peoples Hospital
Chengdu, 610072, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
Nanfang Hospital of Southern Medical Hospital
Guangzhou, 510515, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, 550004, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310018, China
The First Hospital of Jiaxing
Jiaxing, 314001, China
Jinhua municipal central hospital
Jinhua, 321013, China
Linyi City People Hospital
Linyi, 276002, China
The Second Affiliated Hospital of Nanchang University
Nanchang, 330008, China
Affiliated Hospital of Nantong University
Nantong, 226001, China
Pingxiang People's Hospital
Pingxiang, 337055, China
Huashan Hospital Fudan University
Shanghai, 200040, China
Shanghai skin disease hospital
Shanghai, 200443, China
Shenzhen People s Hospital
Shenzhen, 518020, China
Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
Shanxi Bethune Hospital
Taiyuan, 030032, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710006, China
Revmacentrum MUDr Mostera s r o
Brno, 615 00, Czechia
Revmatologie s r o
Brno, 63800, Czechia
RHEUMA s r o
Břeclav, 690 02, Czechia
L K N Arthrocentrum
Hlučín, 748 01, Czechia
CCR Ostrava S R O
Ostrava, 70200, Czechia
MUDr Rosypalova s r o
Ostrava, 708 00, Czechia
FN Motol
Prague, 15000, Czechia
Medical Plus S R O
Uherské Hradiště, 68601, Czechia
PV Medical S R O
Zlín, 76001, Czechia
Aarhus University Hospital
Aarhus N, 8200, Denmark
Sydvestjysk Sygehus
Esbjerg, 6700, Denmark
Frederiksberg Hospital
Frederiksberg, 2000, Denmark
Regionshospitalet Godstrup
Herning, 7400, Denmark
Svendborg Hospital Odense University Hospital
Svendborg, 5700, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Charite - Campus Mitte
Berlin, 10117, Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789, Germany
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, 01307, Germany
Medizinische Fakultaet Der Albert Ludwigs Universitaet Freiburg
Freiburg im Breisgau, 79106, Germany
Hamburger Rheuma Forschungszentrum II
Hamburg, 20095, Germany
Rheumazentrum Ruhrgebiet
Herne, 44649, Germany
Praxis Dr. med. Beate Schwarz - Germany
Langenau, 89129, Germany
Rheumaforschung - Studienambulanz Dr. Wassenberg
Ratingen, 40878, Germany
Universitatsklinikum Tubingen
Tübingen, 72076, Germany
Prince of Wales Hospital
Hong Kong, 000000, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest, 1023, Hungary
Revita Kft
Budapest, 1027, Hungary
Qualiclinic Kft
Budapest, 1134, Hungary
Uno Medical Trials Ltd.
Budapest, 1152, Hungary
Debreceni Egyetem Reumatologiai Klinika
Debrecen, 4032, Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700, Hungary
Obudai Egeszsegugyi Centrum Kft
Kaposvár, 7400, Hungary
Bacs Kiskun Varmegyei Oktatokorhaz
Kecskemét, 6000, Hungary
University of Szeged
Szeged, 6725, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
Székesfehérvár, 8000, Hungary
MAV Korhaz es Rendelointezet
Szolnok, 5000, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprém, 8200, Hungary
Marengo Cims Hospital
Ahmedabad, 380060, India
Apollo Hospitals
Bhubaneswar, 751005, India
Sushruta Multispeciality Hospital
Hubballi, 580021, India
Apollo Multispeciality Hospital Ltd
Kolkata, 700054, India
JSS Hospital
Mysuru, 570004, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Indraprastha Apollo Hospital
New Delhi, 1100776, India
Fortis Hospital
Noida, 201301, India
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
Surat, 395002, India
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona, 60126, Italy
ASST Spedali Civili Brescia
Brescia, 25123, Italy
Policlinico San Marco
Catania, 95124, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliero Universitaria Luigi Vanvitelli
Naples, 80138, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Universita Degli Studi di Roma Tor Vergata
Roma, 00133, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, 53100, Italy
Ospedale S. Maria Della Misericordia
Udine, 33100, Italy
St. Luke's International Hospital
Chūōku, 104 8560, Japan
Kansai Medical University Hospital
Hirakata, 573 1191, Japan
Kita-harima Medical Center
Hyōgo, 6751392, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, 807-8556, Japan
Nagoya City University Hospital
Nagoya, 467 8602, Japan
Osaka Metropolitan University Hospital
Osaka, 545 8586, Japan
Maeshima Rheumatology Clinic
Ōita, 870 0030, Japan
Sanuki Municipal Hospital
Sanuki, 7692393, Japan
Sasebo Chuo Hospital
Sasebo, 857 1195, Japan
Tohoku University Hospital
Sendai, 980 8574, Japan
Dokkyo Medical University Hospital
Shimotsuga Gun, 321 0293, Japan
Kyorin University Hospital
Tokyo, 181 8611, Japan
Mie University Hospital
Tsu, 514 8507, Japan
Hospital Sultanah Bahiyah
Alor Star, 05460, Malaysia
Hospital Selayang
Batu Caves, 68100, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, 30450, Malaysia
Hospital Sultan Ismail
Johor Bahru, 81100, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Hospital Tuanku Jaafar
Seremban, 70300, Malaysia
Centro de Investigacion de Tratamientos Innovadores de Sinaloa
Culiacán, 80000, Mexico
Grupo Clinico CATEI
Guadalajara, 44630, Mexico
Centro Medico del Angel
Mexicali, 45116, Mexico
RM Pharma Specialists
Mexico City, 03100, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion
San Luis Potosí City, 78213, Mexico
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok, 15-351, Poland
Specderm Poznanska sp j
Bialystok, 15-375, Poland
ClinicMed Daniluk Nowak Spolka Komandytowa
Bialystok, 15-879, Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Ambulatorium sp. z o.o.
Elblag, 82-300, Poland
Centrum Kliniczno Badawcze
Elblag, 82-300, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338, Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow, 30-002, Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, 30-002, Poland
Centrum Medyczne All Med
Krakow, 30-033, Poland
Pratia MCM Krakow
Krakow, 30-727, Poland
Dermed Centrum Medyczne Sp z o o
Lodz, 90-265, Poland
Zespol Poradni Specjalistycznych Reumed Filia nr 1
Lublin, 20-607, Poland
NZOZ Lecznica MAK MED S C
Nadarzyn, 05-830, Poland
MICS Centrum Medyczne Torun
Torun, 87-100, Poland
MICS Centrum Medyczne Warszawa
Warsaw, 00-874, Poland
Centrum Medyczne Reuma Park
Warsaw, 02-665, Poland
DermMedica Sp z o o
Wroclaw, 51-503, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
S C Delta Health Care S R L
Bucharest, 014142, Romania
Ecomed Research SRL
Craiova, 200400, Romania
Centrul Medical Unirea
Iași, 700259, Romania
Medaudio Optica S R L
Râmnicu Vâlcea, 247065, Romania
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp Reina Sofia
Córdoba, 14004, Spain
Hosp. Univ. de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hosp. Univ. Infanta Leonor
Madrid, 28031, Spain
Hosp Regional Univ de Malaga
Málaga, 29009, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Virgen Macarena
Seville, 41009, Spain
Hosp. Infanta Luisa
Seville, 41010, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
National Taiwan University Hospital Hsin Chu Branch
Hsinchu, 300, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Chi Mei Medical Center
Tainan, 710, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Saraburi Hospital
Changwat Sara Buri, 18000, Thailand
Songklanagarind hospital
Songkhla, 90110, Thailand
Royal Free London NHS Foundation Trust
Barnet, EN5 3DJ, United Kingdom
Basingstoke And North Hampshire Hospital
Basingstoke, RG24 9NA, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Christchurch, BH23 2JX, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Glasgow Royal Infirmary
Glasgow, G31 2ER, United Kingdom
Hereford County Hospital
Hereford, HR1 2ER, United Kingdom
Forth Valley Royal Hospital
Larbert, FK5 4WR, United Kingdom
Haywood Hospital
Staffordshire, ST6 7AG, United Kingdom
Torbay Hospital-Devon
Torquay, TQ2 7AA, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Betsi Cadwaladr University Health Board BCUHB
Wrexham, LL13 7TD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2025
First Posted
February 4, 2025
Study Start
January 9, 2025
Primary Completion (Estimated)
February 10, 2027
Study Completion (Estimated)
October 18, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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