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

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Treatment

Placebo

Icotrokinra

Active reference comparator

Clinical Study ID

NCT06878404
77242113PSA3001
77242113PSA3001
2023-509239-19-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the firstadministration of study intervention and meet classification criteria for psoriaticarthritis (CASPAR) at screening

  • Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tenderjoints at screening and at baseline (b) C-reactive protein (CRP) greater than orequal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the centrallaboratory

  • 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 diameteror nail changes consistent with psoriasis

  • A female participant of childbearing potential must have a negative highly sensitiveserum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test atWeek 0 prior to administration of study intervention

Exclusion

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 uncontrolledrenal, 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 itsexcipients

  • Has other inflammatory diseases that might confound the evaluations of benefit oficotrokinra therapy, including but not limited to rheumatoid arthritis (RA),systemic lupus erythematosus, or lyme disease

  • Participants with fibromyalgia or osteoarthritis symptoms that, in theinvestigator's opinion, would have potential to interfere with efficacy assessments

Study Design

Total Participants: 540
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 21, 2025
Estimated Completion Date:
December 29, 2028

Connect with a study center

  • Cosultorios Reumatologógicos Pampa

    Buenos Aires, 1428
    Argentina

    Active - Recruiting

  • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

    Buenos Aires, C1426BOS
    Argentina

    Active - Recruiting

  • Mindout Research

    Ciudad Autonoma de Buenos Aires, C1417EYG
    Argentina

    Active - Recruiting

  • Centro Medico Privado de Reumatologia Tucuman

    Ciudad De San Miguel De Tucuman, T4000AXL
    Argentina

    Active - Recruiting

  • Arsema

    Ciudad de Buenos Aires, C1431
    Argentina

    Active - Recruiting

  • Ipswich Hospital

    Ipswich, 4305
    Australia

    Active - Recruiting

  • Rheumatology Research Unit

    Maroochydore, 4558
    Australia

    Active - Recruiting

  • BJC Health

    Parramatta, 2150
    Australia

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    ChangSha, 410008
    China

    Active - Recruiting

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072
    China

    Active - Recruiting

  • West China Hospital Sichuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 4000016
    China

    Active - Recruiting

  • Nanfang Hospital of Southern Medical Hospital

    Guangzhou, 510515
    China

    Active - Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 561113
    China

    Active - Recruiting

  • Linyi City People Hospital

    Linyi City, 276002
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, 226001
    China

    Active - Recruiting

  • Pingxiang People's Hospital

    Pingxiang, 337055
    China

    Active - Recruiting

  • Huashan Hospital Fudan University

    Shanghai, 200040
    China

    Active - Recruiting

  • Shenzhen People s Hospital

    Shenzhen, 518020
    China

    Active - Recruiting

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, 050051
    China

    Active - Recruiting

  • Soochow University, The Second Affiliated Hospital of

    Suzhou, 215000
    China

    Active - Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, 030032
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212001
    China

    Active - Recruiting

  • L K N Arthrocentrum

    Hlucin, 748 01
    Czechia

    Active - Recruiting

  • Sydvestjysk Sygehus

    Esbjerg, 6700
    Denmark

    Active - Recruiting

  • Frederiksberg Hospital

    Frederiksberg, 2000
    Denmark

    Active - Recruiting

  • Svendborg Hospital Odense University Hospital

    Svendborg, 5700
    Denmark

    Active - Recruiting

  • Vejle Sygehus

    Vejle, 7100
    Denmark

    Active - Recruiting

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095
    Germany

    Active - Recruiting

  • Studienzentrum Dr Schwarz Germany

    Langenau, 89129
    Germany

    Active - Recruiting

  • Universitatsklinikum Tubingen

    Tubingen, 72076
    Germany

    Active - Recruiting

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1027
    Hungary

    Active - Recruiting

  • Qualiclinic Kft

    Budapest, 1036
    Hungary

    Active - Recruiting

  • MAV Korhaz es Rendelointezet

    Szolnok, 5000
    Hungary

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka, 814 0180
    Japan

    Active - Recruiting

  • Teikyo University Hospital

    Itabashi Ku, 173 8606
    Japan

    Active - Recruiting

  • Kagawa University Hospital

    Kita Gun, 761 0793
    Japan

    Active - Recruiting

  • Maeshima Rheumatology Clinic

    Oita, 870 0823
    Japan

    Active - Recruiting

  • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

    Osaka, 550 0006
    Japan

    Active - Recruiting

  • Sasebo Chuo Hospital

    Sasebo, 857 1195
    Japan

    Active - Recruiting

  • Kyorin University Hospital

    Tokyo, 181 8611
    Japan

    Active - Recruiting

  • Mie University Hospital

    Tsu, 514 8507
    Japan

    Active - Recruiting

  • NZOZ Osteo Medic S C Artur Racewicz i Jerzy Supronik

    Bialystok, 15 351
    Poland

    Active - Recruiting

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05 830
    Poland

    Active - Recruiting

  • Etyka Osrodek Badan Klinicznych

    Olsztyn, 10 117
    Poland

    Active - Recruiting

  • Centrum Medyczne Reuma Park

    Warszawa, 02 665
    Poland

    Active - Recruiting

  • Hosp Univ A Coruna

    A Coruna, 15006
    Spain

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hosp Reina Sofia

    Cordoba, 14004
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp Regional Univ de Malaga

    Malaga, 29009
    Spain

    Active - Recruiting

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hosp. Infanta Luisa

    Sevilla, 41010
    Spain

    Active - Recruiting

  • Hosp. Quiron Sagrado Corazon

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hosp. Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hosp. Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • National Taiwan University Hospital Hsin Chu Branch

    Hsin Chu, 300
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital

    Kaohsiung City, 833
    Taiwan

    Active - Recruiting

  • Chi Mei Medical Center Yong Kang

    Tainan, 710
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Phramongkutklao Hospital

    Bangkok, 10400
    Thailand

    Active - Recruiting

  • Siriraj Hospital

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Songklanagarind hospital

    Songkhla, 90110
    Thailand

    Active - Recruiting

  • Omega Research Consultants

    DeBary, Florida 32713
    United States

    Active - Recruiting

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Joint and Muscle Research Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

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