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A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1)

Last Updated   May 21, 2025

Want to learn how to participate in this trial?

77242113PSA3001

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
  • Sites
    74 Sites
  • Status
    Recruiting

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.

CONDITIONS

  • Arthritis, Psoriatic

ELIGIBILITY


Inclusion Criteria:

* 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


Exclusion Criteria:

* 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


Inclusion Criteria:

* 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 j

More...

DETAILS

LOCATIONS

Locations in:
United States, Australia, China, Japan, Taiwan, Argentina, Czechia, Denmark, Germany, Hungary, Poland, Spain, Thailand
Country (13) City or Province (74) Status
United States DeBary Omega Research Consultants
RECRUITING
Australia Parramatta BJC Health
RECRUITING
China Beijing Peking University Third Hospital
RECRUITING
China Chengdu Sichuan Provincial Peoples Hospital
RECRUITING
China Guiyang The Affiliated Hospital of Guizhou Medical University
RECRUITING
China Shanghai Huashan Hospital Fudan University
RECRUITING
China Taiyuan Shanxi Bethune Hospital
RECRUITING
China Wenzhou The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Japan Itabashi Ku Teikyo University Hospital
RECRUITING
Japan Oita Maeshima Rheumatology Clinic
RECRUITING
Japan Sasebo Sasebo Chuo Hospital
RECRUITING
Taiwan Hsin Chu National Taiwan University Hospital Hsin Chu Branch
RECRUITING
United States Plantation Integral Rheumatology And Immunology Specialists
RECRUITING
United States Willowbrook Willow Rheumatology and Wellness PLLC
RECRUITING
United States Charlotte Joint and Muscle Research Institute
RECRUITING
United States Duncansville Altoona Center For Clinical Research
RECRUITING
Argentina Buenos Aires Cosultorios Reumatologógicos Pampa
RECRUITING
Argentina Buenos Aires Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
RECRUITING
Argentina Ciudad Autonoma de Buenos Aires Mindout Research
RECRUITING
Argentina Ciudad de Buenos Aires Arsema
RECRUITING
Argentina Ciudad De San Miguel De Tucuman Centro Medico Privado de Reumatologia Tucuman
RECRUITING
Australia Ipswich Ipswich Hospital
RECRUITING
Australia Maroochydore Rheumatology Research Unit
RECRUITING
China ChangSha Xiangya Hospital Central South University
RECRUITING
China Chengdu West China Hospital Sichuan University
RECRUITING
China Chongqing The First Affiliated Hospital of Chongqing Medical University
RECRUITING
China Guangzhou Nanfang Hospital of Southern Medical Hospital
RECRUITING
China Linyi City Linyi City People Hospital
RECRUITING
China Nantong Affiliated Hospital of Nantong University
RECRUITING
China Pingxiang Pingxiang People's Hospital
RECRUITING
China Shenzhen Shenzhen People s Hospital
RECRUITING
China Shijiazhuang The Third Hospital of Hebei Medical University
RECRUITING
China Suzhou Soochow University, The Second Affiliated Hospital of
RECRUITING
China Zhenjiang Affiliated Hospital of Jiangsu University
RECRUITING
Czechia Hlucin L K N Arthrocentrum
RECRUITING
Denmark Esbjerg Sydvestjysk Sygehus
RECRUITING
Denmark Frederiksberg Frederiksberg Hospital
RECRUITING
Denmark Svendborg Svendborg Hospital Odense University Hospital
RECRUITING
Denmark Vejle Vejle Sygehus
RECRUITING
Germany Hamburg Hamburger Rheuma Forschungszentrum II
RECRUITING
Germany Langenau Studienzentrum Dr Schwarz Germany
RECRUITING
Germany Tubingen Universitatsklinikum Tubingen
RECRUITING
Hungary Budapest Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
RECRUITING
Hungary Budapest Qualiclinic Kft
RECRUITING
Hungary Szolnok MAV Korhaz es Rendelointezet
RECRUITING
Japan Fukuoka Fukuoka University Hospital
RECRUITING
Japan Kita Gun Kagawa University Hospital
RECRUITING
Japan Osaka Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
RECRUITING
Japan Tokyo Kyorin University Hospital
RECRUITING
Japan Tsu Mie University Hospital
RECRUITING
Poland Bialystok NZOZ Osteo Medic S C Artur Racewicz i Jerzy Supronik
RECRUITING
Poland Nadarzyn NZOZ Lecznica MAK MED S C
RECRUITING
Poland Olsztyn Etyka Osrodek Badan Klinicznych
RECRUITING
Poland Warszawa Centrum Medyczne Reuma Park
RECRUITING
Spain A Coruna Hosp Univ A Coruna
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Barcelona Hosp. Clinic de Barcelona
RECRUITING
Spain Cordoba Hosp Reina Sofia
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
Spain Malaga Hosp Regional Univ de Malaga
RECRUITING
Spain Sabadell Corporacio Sanitari Parc Tauli
RECRUITING
Spain Santander Hosp. Univ. Marques de Valdecilla
RECRUITING
Spain Sevilla Hosp. Virgen Macarena
RECRUITING
Spain Sevilla Hosp. Infanta Luisa
RECRUITING
Spain Sevilla Hosp. Quiron Sagrado Corazon
RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
RECRUITING
Taiwan Kaohsiung City Chang Gung Memorial Hospital
RECRUITING
Taiwan Tainan National Cheng Kung University Hospital
RECRUITING
Taiwan Tainan Chi Mei Medical Center Yong Kang
RECRUITING
Taiwan Taipei Taipei Veterans General Hospital
RECRUITING
Taiwan Taoyuan Linkou Chang Gung Memorial Hospital
RECRUITING
Thailand Bangkok Phramongkutklao Hospital
RECRUITING
Thailand Bangkok Siriraj Hospital
RECRUITING
Thailand Songkhla Songklanagarind hospital
RECRUITING
Show More
Geo Locations

28.88305, -81.30868

-33.81667, 151

39.9075, 116.39723

30.66667, 104.06667

26.58333, 106.71667

31.22222, 121.45806

37.86944, 112.56028

27.99942, 120.66682

35.74893, 139.71497

33.23333, 131.6

33.16832, 129.72501

24.8039455, 120.9646866

26.13421, -80.23184

41.76975, -87.93589

35.22709, -80.84313

40.42341, -78.4339

-34.61315, -58.37723

-34.61315, -58.37723

-34.61315, -58.37723

-34.61315, -58.37723

-26.8082848, -65.2175903

-27.61181, 152.76821

-26.66008, 153.09953

28.19874, 112.97087

30.66667, 104.06667

29.56278, 106.55278

23.11667, 113.25

35.0732999, 118.34

32.03028, 120.87472

27.61672, 113.85353

22.54554, 114.0683

38.04139, 114.47861

31.30408, 120.59538

32.21086, 119.45508

49.89795, 18.19196

55.47028, 8.45187

55.67938, 12.53463

55.05982, 10.60677

55.70927, 9.5357

53.57532, 10.01534

48.49616, 10.11849

48.52266, 9.05222

47.49801, 19.03991

47.49801, 19.03991

47.18333, 20.2

33.6, 130.41667

34.2939708, 134.1237443

34.69374, 135.50218

35.6895, 139.69171

34.73333, 136.51667

53.13333, 23.16433

52.09438, 20.80776

53.77995, 20.49416

52.22977, 21.01178

43.37135, -8.396

41.38879, 2.15899

41.38879, 2.15899

37.89155, -4.77275

40.4165, -3.70256

36.72016, -4.42034

41.54329, 2.10942

43.46472, -3.80444

37.38283, -5.97317

37.38283, -5.97317

37.38283, -5.97317

37.38283, -5.97317

22.61626, 120.31333

22.99083, 120.21333

22.99083, 120.21333

25.04776, 121.53185

24.95233, 121.20193

13.75398, 100.50144

13.75398, 100.50144

7.19882, 100.5951

x
50

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10

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5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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