A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
ICONIC-PsA 1
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
2 other identifiers
interventional
552
16 countries
155
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2025
Typical duration for phase_3
155 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2025
CompletedFirst Submitted
Initial submission to the registry
March 13, 2025
CompletedFirst Posted
Study publicly available on registry
March 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 4, 2028
April 13, 2026
April 1, 2026
1.3 years
March 13, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants who Achieve an American College of Rheumatology (ACR) 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 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 Achieve 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 an IGA Score of >=2 at Baseline
Week 16
Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
Week 16
Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
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 an IGA Score of >=2 at Baseline
Week 16
Proportion of Participants who Achieve an ACR 50 Response at Week 16
Week 16
- +9 more secondary outcomes
Study Arms (4)
Group I: Icotrokinra Dose 1
EXPERIMENTALParticipants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
Group II: Icotrokinra Dose 2
EXPERIMENTALParticipants will receive icotrokinra dose 2. Participants who continue into a LTE 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. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
Group IV: Active Reference Comparator
ACTIVE COMPARATORParticipants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
Interventions
Icotrokinra will be administered.
Active reference drug will be administered.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
- 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
- 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 (155)
Arthritis and Rheumatism Associates ARA Jonesboro
Jonesboro, Arkansas, 72401, United States
Omega Research Consultants
DeBary, Florida, 32713, United States
Integral Rheumatology And Immunology Specialists
Plantation, Florida, 33324, United States
Clinical Research of West Florida
Tampa, Florida, 33606, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, 60527, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Arthritis and Rheumatology Research Institute
Allen, Texas, 75013, United States
Naiara Alvarez MD Integrative Rheumatology of South TX
Harlingen, Texas, 78550, United States
Cosultorios Reumatologógicos Pampa
Buenos Aires, 1428, Argentina
Mindout Research
Buenos Aires, C1417EYG, Argentina
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
Buenos Aires, C1426BOS, Argentina
Arsema
Ciudad de Buenos Aires, C1431, Argentina
Centro Medico Privado de Reumatologia Tucuman
Ciudad de San Miguel de Tucuman, T4000AXL, Argentina
Consultora Integral de Salud SRL
Córdoba, CP5000, Argentina
MR Medicina Reumatologica
San Fernando, B1646GHP, Argentina
Instituto Medico De Alta Complejidad (IMAC)
San Isidro, B1642IPN, Argentina
Ipswich Hospital
Ipswich, 4305, Australia
Rheumatology Research Unit
Maroochydore, 4558, Australia
BJC Health
Parramatta, 2150, Australia
Queen Elizabeth Hospital
South Woodville, 5011, Australia
Royal Darwin Hospital
Tiwi, 0810, Australia
MC Medtech Services Ltd
Haskovo, 6304, Bulgaria
Exacta Medica
Pleven, 5803, Bulgaria
Medical Center Artmed
Plovdiv, 4002, Bulgaria
Medical Center Teodora
Rousse, 7012, Bulgaria
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, 4000016, China
Nanfang Hospital of Southern Medical Hospital
Guangzhou, 510515, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, 561113, China
Linyi City People Hospital
Linyi, 276002, China
Jiangxi Provincial Peoples Hospital
Nanchang, 330006, 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
The Third Hospital of Hebei Medical University
Shijiazhuang, 050051, China
Second Affiliated Hospital of Soochow University
Suzhou, 215000, 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
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001, China
Revmatologie s r o
Brno, 63800, Czechia
Revmacentrum MUDr Mostera s r o
Brno-Židenice, 615 00, Czechia
RHEUMA s r o
Břeclav, 690 02, Czechia
L K N Arthrocentrum
Hlučín, 748 01, Czechia
Revimex Pro s r o
Karvina Frystat, 73301, Czechia
CCR Ostrava S R O
Ostrava, 70200, Czechia
MUDr Rosypalova s r o
Ostrava, 70800, Czechia
Revmatologicky ustav
Prague, 128 00, Czechia
Revmatologicka Ordinace
Prague, 140 00, Czechia
Thomayerova nemocnice
Prague, 140 59, Czechia
FN Motol
Prague, 150 00, 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
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789, Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Medizinische Fakultat der Albert Ludwigs Universitat Freiburg
Freiburg im Breisgau, 79104, Germany
Hamburger Rheuma Forschungszentrum II
Hamburg, 20095, Germany
Rheumazentrum Ruhrgebiet
Herne, 44649, Germany
Studienzentrum Dr Schwarz Germany
Langenau, 89129, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Universitatsklinikum Tubingen
Tübingen, 72076, Germany
Prince of Wales Hospital
Hong Kong, 000000, Hong Kong
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest, 1027, Hungary
Revita Kft
Budapest, 1027, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Synexus Magyarorszag Kft
Budapest, 1036, Hungary
Qualiclinic Kft
Budapest, 1134, Hungary
Uno Medical Trials Ltd.
Budapest, 1152, Hungary
University of Debrecen
Debrecen, 4032, Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700, Hungary
Obudai Egeszsegugyi Centrum Kft 1
Kaposvár, 7400, Hungary
University of Szeged
Szeged, 6725, 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
Nizams Institute of Medical Sciences
Hyderabad, 500082, India
Apollo Multispeciality Hospital Ltd
Kolkata, 700054, India
Kokilaben Dhirubhai Ambani Hsp And Med Research Inst
Mumbai, 400053, 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 Hospital & Research Centre
Surat, 395002, India
Fukuoka University Hospital
Fukuoka, 814 0180, Japan
Teikyo University Hospital
Itabashi Ku, 173 8606, Japan
Kagawa University Hospital
Kita Gun, 761 0793, Japan
Nagoya City University Hospital
Nagoya, 467 8602, Japan
Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
Osaka, 550 0006, Japan
Maeshima Rheumatology Clinic
Ōita, 870 0823, Japan
Sasebo Chuo Hospital
Sasebo, 857 1195, Japan
Tohoku University Hospital
Sendai, 980 8574, Japan
Kyorin University Hospital
Tokyo, 181 8611, Japan
Mie University Hospital
Tsu, 514 8507, Japan
Osteo Medic S C Artur Racewicz Jerzy 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
Etyka Osrodek Badan Klinicznych
Olsztyn, 10-117, 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
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. Clinic de Barcelona
Barcelona, 8036, Spain
Hosp Reina Sofia
Córdoba, 14004, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp Regional Univ de Malaga
Málaga, 29009, Spain
Corporacio Sanitari Parc Tauli
Sabadell, 08208, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Virgen Macarena
Seville, 41009, Spain
Hosp. Infanta Luisa
Seville, 41010, Spain
Hosp. Quiron Sagrado Corazon
Seville, 41013, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi Mei Medical Center Yong Kang
Tainan, 710, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
National Taiwan University Hospital Hsin Chu Branch
Taoyuan District, 300, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Saraburi Hospital
Changwat Sara Buri, 18000, Thailand
Phra Nakhon Si Ayutthaya Hospital
Phra Nakhon Si Ayutthaya, 13000, Thailand
Songklanagarind hospital
Songkhla, 90110, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
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
March 13, 2025
First Posted
March 17, 2025
Study Start
February 21, 2025
Primary Completion (Estimated)
May 27, 2026
Study Completion (Estimated)
February 4, 2028
Last Updated
April 13, 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