Arthritis, PsoriaticPhase 3ICONIC-PsA 2NCT06807424
A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis
A Phase 3 study testing Icotrokinra in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 236 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- Icotrokinra
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 236 sitesin 24 countries
- Study dates
- 9 Jan 2025to 18 Oct 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
236 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
236 sites in 24 countries
United States25 sites, 21 recruiting
- Recruiting
Albuquerque Rehabilitation and Rheumatology
Albuquerque, New Mexico, 87102
- Completed
DM Clinical Research 1
Brookline, Massachusetts, 02446
- Recruiting
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
- Recruiting
Clinical Research of West Florida
Clearwater, Florida, 33765
- Recruiting
UT Southwestern
Dallas, Texas, 75390
- Recruiting
Omega Research Consultants
DeBary, Florida, 32713
- Recruiting
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
- Completed
St Paul Rheumatology PA
Eagan, Minnesota, 55123
- Recruiting
Arthritis and Rheumatology Research Institute
Frisco, Texas, 75035
- Recruiting
AARA Clinical Research
Glendale, Arizona, 85306
- Recruiting
Center of Rheumatic Diseases
Glendale, Wisconsin, 53217
- Recruiting
Klein And Associates M D P A
Hagerstown, Maryland, 21740
- Suspended
Naiara Alvarez MD Integrative Rheumatology of South TX
Harlingen, Texas, 78550
- Recruiting
AARA Clinical Research Lone Star Arthritis and Rheumatology
Irving, Texas, 75039
- Recruiting
Arthritis and Rheumatism Associates ARA Jonesboro
Jonesboro, Arkansas, 72401
- Recruiting
AARA Clinical Research 1
Mesa, Arizona, 85210
- Recruiting
Suncoast Clinical Research
New Port Richey, Florida, 34652
- Recruiting
Rheumatology Associates of Oklahoma
Oklahoma City, Oklahoma, 73116
- Recruiting
Clinical Research Philadelphia
Philadelphia, Pennsylvania, 19114
- Recruiting
Integral Rheumatology And Immunology Specialists
Plantation, Florida, 33324
- Recruiting
Seattle Rheumatology
Seattle, Washington, 98104
- Completed
Clinic of Robert Hozman
Skokie, Illinois, 60076
- Recruiting
Clinical Research of West Florida 1
Tampa, Florida, 33606
- Recruiting
DM Clinical Research
Tomball, Texas, 77375
- Recruiting
Velocity Clinical Research
Waco, Texas, 76710
China25 sites, 24 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
- Recruiting
Beijing Tong Ren Hospital Capital Medical University
Beijing, 100730
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, 130021
- Recruiting
Xiangya Hospital Central South University
Changsha, 410008
- Recruiting
West China Hospital Sichuan University
Chengdu, 610041
- Recruiting
Sichuan Provincial Peoples Hospital
Chengdu, 610072
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
- Recruiting
Dongguan People s Hospital
Dongguan, 523109
- Active, not recruiting
Nanfang Hospital of Southern Medical Hospital
Guangzhou, 510515
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, 550004
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310018
- Recruiting
The First Hospital of Jiaxing
Jiaxing, 314001
- Recruiting
Jinhua municipal central hospital
Jinhua, 321013
- Recruiting
Linfen Central Hospital
Linfen, 041000
- Recruiting
Linyi City People Hospital
Linyi, 276002
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, 330008
- Recruiting
Affiliated Hospital of Nantong University
Nantong, 226001
- Recruiting
Pingxiang People's Hospital
Pingxiang, 337055
- Recruiting
Huashan Hospital Fudan University
Shanghai, 200040
- Recruiting
Shanghai skin disease hospital
Shanghai, 200443
- Recruiting
Shenzhen People s Hospital
Shenzhen, 518020
- Recruiting
Second Affiliated Hospital of Soochow University
Suzhou, 215004
- Recruiting
Shanxi Bethune Hospital
Taiyuan, 030032
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710006
Poland19 sites, 18 recruiting
- Recruiting
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok, 15-351
- Completed
Specderm Poznanska sp j
Bialystok, 15-375
- Recruiting
ClinicMed Daniluk Nowak Spolka Komandytowa
Bialystok, 15-879
- Recruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
- Recruiting
Ambulatorium sp. z o.o.
Elblag, 82-300
- Recruiting
Centrum Kliniczno Badawcze
Elblag, 82-300
- Recruiting
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338
- Recruiting
Malopolskie Badania Kliniczne Sp z o o
Krakow, 30-002
- Recruiting
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, 30-002
- Recruiting
Centrum Medyczne All Med
Krakow, 30-033
- Recruiting
Pratia MCM Krakow
Krakow, 30-727
- Recruiting
Dermed Centrum Medyczne Sp z o o
Lodz, 90-265
- Recruiting
Zespol Poradni Specjalistycznych Reumed Filia nr 1
Lublin, 20-607
- Recruiting
NZOZ Lecznica MAK MED S C
Nadarzyn, 05-830
- Recruiting
MICS Centrum Medyczne Torun
Torun, 87-100
- Recruiting
MICS Centrum Medyczne Warszawa
Warsaw, 00-874
- Recruiting
Centrum Medyczne Reuma Park
Warsaw, 02-665
- Recruiting
DermMedica Sp z o o
Wroclaw, 51-503
- Recruiting
Centrum Medyczne Oporow
Wroclaw, 52-416
Japan16 sites, 15 recruiting
- Recruiting
NHO Chiba Medical Center Chibahigashi National Hospital
Chiba, 260-8712
- Recruiting
St. Luke's International Hospital
Chūōku, 104 8560
- Recruiting
Kansai Medical University Hospital
Hirakata, 573 1191
- Completed
Kita-harima Medical Center
Hyōgo, 6751392
- Recruiting
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, 807-8556
- Recruiting
Nagoya City University Hospital
Nagoya, 467 8602
- Recruiting
Maeshima Rheumatology Clinic
Ōita, 870 0030
- Recruiting
Osaka Metropolitan University Hospital
Osaka, 545 8586
- Recruiting
Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
Osaka, 550 0006
- Recruiting
Sanuki Municipal Hospital
Sanuki, 7692393
- Recruiting
Sasebo Chuo Hospital
Sasebo, 857 1195
- Recruiting
Tohoku University Hospital
Sendai, 980 8574
- Recruiting
Dokkyo Medical University Hospital
Shimotsuga Gun, 321 0293
- Recruiting
Kyorin University Hospital
Tokyo, 181 8611
- Recruiting
Mie University Hospital
Tsu, 514 8507
- Recruiting
National Hospital Organization Yokohama Medical Center
Yokohama, 245-8575
Hungary15 sites, 13 recruiting
- Recruiting
Trial Pharma Kft
Békéscsaba, 5600
- Recruiting
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest, 1023
- Recruiting
Revita Kft
Budapest, 1027
- Recruiting
Qualiclinic Kft
Budapest, 1134
- Recruiting
Uno Medical Trials Ltd.
Budapest, 1152
- Recruiting
Debreceni Egyetem Reumatologiai Klinika
Debrecen, 4032
- Recruiting
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700
- Recruiting
Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
Hódmezővásárhely, 6800
- Completed
Obudai Egeszsegugyi Centrum Kft
Kaposvár, 7400
- Completed
Bacs Kiskun Varmegyei Oktatokorhaz
Kecskemét, 6000
- Recruiting
University of Szeged
Szeged, 6725
- Recruiting
Complex Rendelo Med Zrt
Székesfehérvár, 8000
- Recruiting
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
Székesfehérvár, 8000
- Recruiting
MAV Korhaz es Rendelointezet
Szolnok, 5000
- Recruiting
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprém, 8200
Italy11 sites, 11 recruiting
- Recruiting
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona, 60126
- Recruiting
ASST Spedali Civili Brescia
Brescia, 25123
- Recruiting
Policlinico San Marco
Catania, 95124
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Azienda Ospedaliero Universitaria Luigi Vanvitelli
Naples, 80138
- Recruiting
IRCCS Policlinico San Matteo
Pavia, 27100
- Recruiting
Universita Degli Studi di Roma Tor Vergata
Roma, 00133
- Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
- Recruiting
Istituto Clinico Humanitas
Rozzano, 20089
- Recruiting
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, 53100
- Recruiting
Ospedale S. Maria Della Misericordia
Udine, 33100
Spain11 sites, 11 recruiting
- Recruiting
Hosp Univ A Coruna
A Coruña, 15006
- Recruiting
Hosp Reina Sofia
Córdoba, 14004
- Recruiting
Hosp. Univ. de Bellvitge
L'Hospitalet de Llobregat, 08907
- Recruiting
Hosp. Univ. Infanta Leonor
Madrid, 28031
- Recruiting
Hosp Regional Univ de Malaga
Málaga, 29009
- Recruiting
Hosp. Univ. Marques de Valdecilla
Santander, 39008
- Recruiting
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
- Recruiting
Hosp. Virgen Macarena
Seville, 41009
- Recruiting
Hosp. Infanta Luisa
Seville, 41010
- Recruiting
Hosp. Virgen Del Rocio
Seville, 41013
- Recruiting
Hosp. Ntra. Sra. de Valme
Seville, 41014
United Kingdom11 sites, 11 recruiting
- Recruiting
Royal Free London NHS Foundation Trust
Barnet, EN5 3DJ
- Recruiting
Basingstoke And North Hampshire Hospital
Basingstoke, RG24 9NA
- Recruiting
University Hospitals Dorset NHS Foundation Trust
Christchurch, BH23 2JX
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
- Recruiting
Glasgow Royal Infirmary
Glasgow, G31 2ER
- Recruiting
Hereford County Hospital
Hereford, HR1 2ER
- Recruiting
Forth Valley Royal Hospital
Larbert, FK5 4WR
- Recruiting
Haywood Hospital
Staffordshire, ST6 7AG
- Recruiting
Torbay Hospital-Devon
Torquay, TQ2 7AA
- Recruiting
New Cross Hospital
Wolverhampton, WV10 0QP
- Recruiting
Betsi Cadwaladr University Health Board BCUHB
Wrexham, LL13 7TD
Czechia10 sites, 10 recruiting
- Recruiting
RHEUMA s r o
Břeclav, 690 02
- Recruiting
Revmacentrum MUDr Mostera s r o
Brno, 615 00
- Recruiting
Revmatologie s r o
Brno, 63800
- Recruiting
L K N Arthrocentrum
Hlučín, 748 01
- Recruiting
CCR Ostrava S R O
Ostrava, 70200
- Recruiting
MUDr Rosypalova s r o
Ostrava, 708 00
- Recruiting
Pratia Czech s r o
Prague, 13000
- Recruiting
FN Motol
Prague, 15000
- Recruiting
Medical Plus S R O
Uherské Hradiště, 68601
- Recruiting
PV Medical S R O
Zlín, 76001
Germany10 sites, 8 recruiting
- Recruiting
Charite - Campus Mitte
Berlin, 10117
- Recruiting
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789
- Recruiting
Krankenhaus Porz am Rhein
Cologne, 51149
- Completed
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, 01307
- Recruiting
Medizinische Fakultaet Der Albert Ludwigs Universitaet Freiburg
Freiburg im Breisgau, 79106
- Recruiting
Hamburger Rheuma Forschungszentrum II
Hamburg, 20095
- Recruiting
Rheumazentrum Ruhrgebiet
Herne, 44649
- Recruiting
Praxis Dr. med. Beate Schwarz - Germany
Langenau, 89129
- Completed
Rheumaforschung - Studienambulanz Dr. Wassenberg
Ratingen, 40878
- Recruiting
Universitatsklinikum Tubingen
Tübingen, 72076
India9 sites, 8 recruiting
- Recruiting
Marengo Cims Hospital
Ahmedabad, 380060
- Recruiting
Apollo Hospitals
Bhubaneswar, 751005
- Recruiting
Sushruta Multispeciality Hospital
Hubballi, 580021
- Recruiting
Apollo Multispeciality Hospital Ltd
Kolkata, 700054
- Completed
JSS Hospital
Mysuru, 570004
- Recruiting
All India Institute of Medical Sciences
New Delhi, 110029
- Recruiting
Indraprastha Apollo Hospital
New Delhi, 1100776
- Recruiting
Fortis Hospital
Noida, 201301
- Recruiting
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
Surat, 395002
Bulgaria8 sites, 5 recruiting
- Recruiting
UMHAT Kaspela
Plovdiv, 4001
- Completed
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, 4003
- Completed
Diagnostic Consulting Center I Sliven
Sliven, 8801
- Recruiting
Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
Sofia, 1336
- Completed
MC Ekselsior
Sofia, 1407
- Recruiting
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, 1431
- Recruiting
UMHAT St. Ivan Rilski
Sofia, 1612
- Recruiting
ASIMP Rheumatology Centre St Irina EOOD
Sofia, 1750
Canada7 sites, 6 recruiting
- Recruiting
Hospital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
- Recruiting
The Waterside Clinic
Orillia, Ontario, L3V 1T5
- Recruiting
Eastern Regional Health Authority St Clares Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8
- Recruiting
Womens College Hospital
Toronto, Ontario, M5S 1B1
- Recruiting
Centre de Recherche Musculo Squelettique
Trois-Rivières, Quebec, G9A 3X2
- Completed
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4
- Recruiting
Dr Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
Romania7 sites, 7 recruiting
- Recruiting
Quantum Medical Center Srl
Bucharest, 012071
- Recruiting
S C Delta Health Care S R L
Bucharest, 014142
- Recruiting
CCBR Clinical Research
Bucharest, 030463
- Recruiting
Hiperdia Piata Sudului
Bucharest, 041312
- Recruiting
Ecomed Research SRL
Craiova, 200400
- Recruiting
Centrul Medical Unirea
Iași, 700259
- Recruiting
Medaudio Optica S R L
Râmnicu Vâlcea, 247065
Argentina6 sites, 6 recruiting
- Recruiting
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, B1643CRO
- Recruiting
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires, C1406AGA
- Recruiting
Hospital Militar Central Cir. My. Dr. Cosme Argerich
Buenos Aires, C1426
- Recruiting
Arsema
Ciudad de Buenos Aires, C1431
- Recruiting
Centro Medico Privado de Reumatologia Tucuman
Ciudad de San Miguel de Tucuman, T4000AXL
- Recruiting
MR Medicina Reumatologica
San Fernando, B1646GHP
Brazil6 sites
- Completed
Faculdade de Medicina Universidade Federal de Minas Gerais
Belo Horizonte, 30130 100
- Active, not recruiting
LMK Servicos Medicos S S
Porto Alegre, 90480 000
- Active, not recruiting
Funfarme Sjrp
São José do Rio Preto, 15090-000
- Active, not recruiting
BR Trials
São Paulo, 01236030
- Active, not recruiting
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
São Paulo, 04266 010
- Active, not recruiting
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403 900
Denmark6 sites, 6 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
- Recruiting
Sydvestjysk Sygehus
Esbjerg, 6700
- Recruiting
Frederiksberg Hospital
Frederiksberg, 2000
- Recruiting
Regionshospitalet Godstrup
Herning, 7400
- Recruiting
Svendborg Hospital Odense University Hospital
Svendborg, 5700
- Recruiting
Vejle Sygehus
Vejle, 7100
Malaysia6 sites, 6 recruiting
- Recruiting
Hospital Sultanah Bahiyah
Alor Star, 05460
- Recruiting
Hospital Selayang
Batu Caves, 68100
- Recruiting
Hospital Raja Permaisuri Bainun
Ipoh, 30450
- Recruiting
Hospital Sultan Ismail
Johor Bahru, 81100
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, 50586
- Recruiting
Hospital Tuanku Jaafar
Seremban, 70300
Mexico6 sites, 6 recruiting
- Recruiting
Centro de Investigacion de Tratamientos Innovadores de Sinaloa
Culiacán, 80000
- Recruiting
Grupo Clinico CATEI
Guadalajara, 44630
- Recruiting
Centro Medico del Angel
Mexicali, 45116
- Recruiting
RM Pharma Specialists
Mexico City, 03100
- Recruiting
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
- Recruiting
Centro de Alta Especialidad en Reumatologia e Investigacion
San Luis Potosí City, 78213
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Gulhane Egitim ve Arastirma Hastanesi
Ankara, 06010
- Recruiting
Gazi Universitesi Tip Fakultesi
Ankara, 06570
- Recruiting
Sanko Universitesi Hastanesi
Gaziantep, 27090
- Recruiting
Marmara University Medical Faculty
Istanbul, 34899
- Recruiting
Kocaeli University Medical Faculty
Kocaeli, 41001
- Recruiting
Necmettin Erbakan Universitesi Tip Fakultesi
Konya, 42080
Australia5 sites, 5 recruiting
- Recruiting
Ipswich Hospital
Ipswich, 4305
- Recruiting
Rheumatology Research Unit
Maroochydore, 4558
- Recruiting
Queen Elizabeth Hospital
South Woodville, 5011
- Recruiting
Royal North Shore Hospital
St Leonards, 2065
- Recruiting
Royal Darwin Hospital
Tiwi, 0810
Thailand5 sites, 5 recruiting
- Recruiting
Phramongkutklao Hospital
Bangkok, 10400
- Recruiting
Rajavithi Hospital
Bangkok, 10400
- Recruiting
Siriraj Hospital
Bangkok, 10700
- Recruiting
Saraburi Hospital
Changwat Sara Buri, 18000
- Recruiting
Songklanagarind hospital
Songkhla, 90110
Taiwan4 sites, 4 recruiting
- Recruiting
National Taiwan University Hospital Hsin Chu Branch
Hsinchu, 300
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
- Recruiting
Chi Mei Medical Center
Tainan, 710
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Hong Kong2 sites, 2 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, 000000
- Recruiting
Queen Mary Hospital
Hong Kong
About this study
Official title: 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
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.
- Conditions
- Arthritis, Psoriatic
- Being tested
- Icotrokinra, Placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotrokinraDrug
Also called JNJ-77242113
Icotrokinra will be administered.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Icotrokinra Dose 1 | Experimental | 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. Receives: Drug: Icotrokinra |
| Group II: Icotrokinra Dose 2 | Experimental | 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. Receives: Drug: Icotrokinra |
| Group III: Placebo | Placebo comparator | 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. Receives: Drug: Icotrokinra; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: Week 16
Proportion of Participants who Achieved an ACR 50 Response at 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).
Measured: Week 16
Proportion of Participants who Achieved an ACR 70 Response at 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).
Measured: Week 16
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At 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.
Measured: 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
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).
Measured: From baseline up to Week 16
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline
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).
Measured: Week 16
Change From Baseline in Enthesitis Score at Week 16 in Participants With Enthesitis at Baseline
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).
Measured: Baseline and Week 16
Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline
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.
Measured: Week 16
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline
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.
Measured: From baseline up to Week 16
Proportion of Participants who Achieved Minimal Disease Activity (MDA) at 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.
Measured: Week 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at 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.
Measured: From baseline up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start9 Jan 2025
- Primary completion10 Feb 2027 (estimated)
- Study completion18 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807424
- Sponsor's protocol ID
- 77242113PSA3002
- Other IDs
- 2024-517284-23-00
- Acronym
- ICONIC-PsA 2
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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