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A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2)

Last Updated   May 17, 2025

Want to learn how to participate in this trial?

77242113PSA3002

OVERVIEW

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

SUMMARY

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

CONDITIONS

  • Arthritis, Psoriatic

ELIGIBILITY


Inclusion Criteria:

* Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and the reason for discontinuation must be documented
* 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 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


Inclusion Criteria:

* Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and the reason for discontinuation must be documented
* Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first admin

More...

DETAILS

LOCATIONS

Locations in:
United States, China, Japan, Taiwan, Argentina, Australia, Canada, Denmark, Germany, Hong Kong, Hungary, Poland, Spain, Thailand, United Kingdom
Country (15) City or Province (76) Status
United States Plantation Integral Rheumatology And Immunology Specialists
RECRUITING
China Shanghai Huashan Hospital Fudan University
RECRUITING
Japan Oita Maeshima Rheumatology Clinic
RECRUITING
Taiwan Taipei Taipei Veterans General Hospital
RECRUITING
United States Mesa AARA Clinical Research
RECRUITING
United States Jonesboro Arthritis and Rheumatism Associates ARA Jonesboro
RECRUITING
United States Clearwater Clinical Research of West Florida
RECRUITING
United States DeBary Omega Research Consultants
RECRUITING
United States Tampa Clinical Research of West Florida
RECRUITING
United States Skokie Clinic of Robert Hozman
RECRUITING
United States Hagerstown Klein And Associates M D P A
RECRUITING
United States Eagan St Paul Rheumatology PA
RECRUITING
United States Charlotte Joint and Muscle Research Institute
RECRUITING
United States Oklahoma City Rheumatology Associates of Oklahoma
RECRUITING
United States Duncansville Altoona Center For Clinical Research
RECRUITING
United States Tomball DM Clinical Research
RECRUITING
Argentina Buenos aires ARCIS Salud SRL Aprillus asistencia e investigacion
RECRUITING
Argentina Ciudad Autonoma de Buenos Aires Hospital Militar Central Cir. My. Dr. Cosme Argerich
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
Australia St Leonards Royal North Shore Hospital
RECRUITING
Canada Trois Rivieres Centre de Recherche Musculo Squelettique
RECRUITING
China Beijing Peking University Third Hospital
RECRUITING
China ChangSha Xiangya Hospital Central South University
RECRUITING
China Chengdu West China Hospital Sichuan University
RECRUITING
China Chengdu Sichuan Provincial Peoples Hospital
RECRUITING
China Chongqing The First Affiliated Hospital of Chongqing Medical University
RECRUITING
China Guangzhou Nanfang Hospital of Southern Medical Hospital
RECRUITING
China Guiyang The Affiliated Hospital of Guizhou Medical University
RECRUITING
China Hangzhou Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
China Jiaxing The First Hospital of Jiaxing
RECRUITING
China Jinhua Jinhua municipal central hospital
RECRUITING
China Linyi City Linyi City People Hospital
RECRUITING
China Nanchang The Second Affiliatde Hospital To Nanchang University
RECRUITING
China Nantong Affiliated Hospital of Nantong University
RECRUITING
China Pingxiang Pingxiang People's Hospital
RECRUITING
China Shenzhen Shenzhen People s Hospital
RECRUITING
China Suzhou Second Affiliated Hospital of Soochow University
RECRUITING
China Taiyuan Shanxi Bethune Hospital
RECRUITING
China Wenzhou The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Denmark Esbjerg Sydvestjysk Sygehus
RECRUITING
Denmark Vejle Vejle Sygehus
RECRUITING
Germany Hamburg Hamburger Rheuma Forschungszentrum II
RECRUITING
Germany Langenau Praxis Dr. med. Beate Schwarz - Germany
RECRUITING
Germany Ratingen Rheumaforschung - Studienambulanz Dr. Wassenberg
RECRUITING
Germany Tubingen Universitatsklinikum Tubingen
RECRUITING
Hong Kong Hong Kong Queen Mary Hospital
RECRUITING
Hungary Budapest Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
RECRUITING
Hungary Budapest Qualiclinic Kft
RECRUITING
Hungary Szolnok MAV Korhaz es Rendelointezet
RECRUITING
Japan Chuo ku St. Luke's International Hospital
RECRUITING
Japan Hyogo Kita-harima Medical Center
RECRUITING
Japan Osaka Osaka Metropolitan University Hospital
RECRUITING
Japan Sanuki Sanuki Municipal Hospital
RECRUITING
Japan Sasebo Sasebo Chuo Hospital
RECRUITING
Japan Shimotsuga Gun Dokkyo Medical University 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
Spain A Coruna Hosp Univ A Coruna
RECRUITING
Spain Cordoba Hosp Reina Sofia
RECRUITING
Spain Santander Hosp. Univ. Marques de Valdecilla
RECRUITING
Spain Santiago de Compostela Hosp. Clinico Univ. de Santiago
RECRUITING
Spain Sevilla Hosp. Virgen Macarena
RECRUITING
Spain Sevilla Hosp. Infanta Luisa
RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
RECRUITING
Taiwan Hsin Chu National Taiwan University Hospital Hsin Chu Branch
RECRUITING
Taiwan Kaohsiung Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Taiwan Tainan Chi Mei Medical Center
RECRUITING
Thailand Bangkok Phramongkutklao Hospital
RECRUITING
Thailand Bangkok Siriraj Hospital
RECRUITING
Thailand Songkhla Songklanagarind hospital
RECRUITING
United Kingdom Basingstoke Basingstoke And North Hampshire Hospital
RECRUITING
United Kingdom Staffordshire Haywood Hospital
RECRUITING
Show More
Geo Locations

26.13421, -80.23184

31.22222, 121.45806

33.23333, 131.6

25.04776, 121.53185

33.42227, -111.82264

35.8423, -90.70428

27.96585, -82.8001

28.88305, -81.30868

27.94752, -82.45843

42.03336, -87.73339

39.64176, -77.71999

44.80413, -93.16689

35.22709, -80.84313

35.46756, -97.51643

40.42341, -78.4339

30.09716, -95.61605

-34.61315, -58.37723

-34.61315, -58.37723

-34.61315, -58.37723

-26.8082848, -65.2175903

-27.61181, 152.76821

-26.66008, 153.09953

-33.82344, 151.19836

46.34515, -72.5477

39.9075, 116.39723

28.19874, 112.97087

30.66667, 104.06667

30.66667, 104.06667

29.56278, 106.55278

23.11667, 113.25

26.58333, 106.71667

30.29365, 120.16142

30.7522, 120.75

29.10678, 119.64421

35.0732999, 118.34

28.68396, 115.85306

32.03028, 120.87472

27.61672, 113.85353

22.54554, 114.0683

31.30408, 120.59538

37.86944, 112.56028

27.99942, 120.66682

55.47028, 8.45187

55.70927, 9.5357

53.57532, 10.01534

48.49616, 10.11849

51.29724, 6.84929

48.52266, 9.05222

22.27832, 114.17469

47.49801, 19.03991

47.49801, 19.03991

47.18333, 20.2

35.57779, 139.71685

34.8315917, 134.9516433

34.69374, 135.50218

34.3253204, 134.1720506

33.16832, 129.72501

36.4729244, 139.8232641

35.6895, 139.69171

34.73333, 136.51667

53.13333, 23.16433

43.37135, -8.396

37.89155, -4.77275

43.46472, -3.80444

42.88052, -8.54569

37.38283, -5.97317

37.38283, -5.97317

37.38283, -5.97317

24.8039455, 120.9646866

22.61626, 120.31333

22.99083, 120.21333

13.75398, 100.50144

13.75398, 100.50144

7.19882, 100.5951

51.26249, -1.08708

53.056961, -2.1914135

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