A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

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

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Treatment

Ustekinumab

Guselkumab

Clinical Study ID

NCT05083182
CR109101
2020-005503-40
CNTO1275JPA3001
  • Ages 5-17
  • All Genders

Study Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria withexclusion of enthesitis-related arthritis (ERA). Diagnosis made >=3 months (that is, 90 days) prior to screening

  • Active disease in at least greater than or equal to (>=) 3 joints at screening andat week 0 (defined as swelling or loss of motion with pain and/or tenderness.Swelling alone meets the criteria for an active arthritic joint. In the absence ofswelling, loss of motion with pain or tenderness or both pain and tenderness meetthe criteria for an active arthritic joint

  • Have active disease despite previous non-biologic disease modifying anti-rheumaticdrug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy:Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for atleast 4 weeks or evidence of intolerance

  • Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids orNSAIDs is permitted but must be on stable dose

  • Participants must be up to date with all immunizations in agreement with currentlocal immunization guidelines for immunosuppressed patients

  • Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (exceptnon-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficientwashout period

Exclusion

Exclusion Criteria:

  • Participants with enthesitis-related arthritis (ERA)

  • Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening

  • Have a history of, or ongoing, chronic or recurrent infectious disease

  • Has evidence of herpes zoster infection within 8 weeks prior to Week 0

  • Have a known history of hepatitis C infection or test positive at screening

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Ustekinumab
Phase: 3
Study Start date:
August 30, 2022
Estimated Completion Date:
August 09, 2027

Connect with a study center

  • STAT Research S A

    Ciudad Autonoma Buenos Aires, C1013AAAB
    Argentina

    Active - Recruiting

  • STAT Research S.A.

    Ciudad Autonoma Buenos Aires, C1013AAAB
    Argentina

    Active - Recruiting

  • Hospital de Ninos de Cordoba

    Cordoba, 5000
    Argentina

    Active - Recruiting

  • Instituto Medico Platense

    La Plata, B1900
    Argentina

    Active - Recruiting

  • Instituto Caici

    Rosario, S2000PBJ
    Argentina

    Active - Recruiting

  • Centro Medico Privado de Reumatologia

    San Miguel De Tucuman, T4000AXL
    Argentina

    Active - Recruiting

  • Aarhus Universitetshospital

    Arhus, 8200
    Denmark

    Active - Recruiting

  • Odense Universitets Hospital

    Odense, 5000
    Denmark

    Completed

  • CHU de Caen

    Caen, 14033
    France

    Active - Recruiting

  • Hopital de Bicetre

    Le Kremlin Bicêtre, 94270
    France

    Active - Recruiting

  • Hopital Nord - Marseille

    Marseille, 13015
    France

    Active - Recruiting

  • Hopital Nord Marseille

    Marseille, 13015
    France

    Active - Recruiting

  • CHU de Toulouse Hopital des Enfants

    Toulouse cedex 9, 31059
    France

    Completed

  • Hôpital D'Enfants

    Vandoeuvre les Nancy, 54511
    France

    Active - Recruiting

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Active - Recruiting

  • Helios Kliniken Berlin Buch Gmbh

    Berlin, 13125
    Germany

    Site Not Available

  • Schon Klinik Hamburg Eilbek

    Hamburg, 22081
    Germany

    Active - Recruiting

  • Schön Klinik Hamburg Eilbek

    Hamburg, 22081
    Germany

    Site Not Available

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin, 53757
    Germany

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

    Brescia, 25100
    Italy

    Active - Recruiting

  • Istituto Giannina Gaslini

    Genova, 16147
    Italy

    Active - Recruiting

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

    Milano, 20122
    Italy

    Active - Recruiting

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

    Milano, 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165
    Italy

    Active - Recruiting

  • Investigación y Biomedicina de Chihuahua

    Chihuahua, 31000
    Mexico

    Site Not Available

  • CREA

    Guadalajara, 44100
    Mexico

    Site Not Available

  • Medical Care & Research SA de CV

    Merida, 97070
    Mexico

    Site Not Available

  • CLIDITER, S.A. de C.V.

    México, 06700
    Mexico

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej

    Lodz, 91-738
    Poland

    Active - Recruiting

  • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o

    Sosnowiec, 41 200
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

    Warszawa, 02 637
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

    Warszawa, 02-637
    Poland

    Active - Recruiting

  • First Moscow State Medical University n.a. I.M. Sechenov

    Moscow, 119991
    Russian Federation

    Site Not Available

  • LLC 'Strategic Medical Systems'

    Saint-Petersburg, 192148
    Russian Federation

    Site Not Available

  • Togliatti City Clinical Hospital#5

    Togliatti, 445039
    Russian Federation

    Site Not Available

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp. Univ. Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 8041
    Spain

    Active - Recruiting

  • Hosp Reina Sofia

    Cordoba, 14004
    Spain

    Active - Recruiting

  • Hosp. Reina Sofia

    Cordoba, 14004
    Spain

    Active - Recruiting

  • Hosp. Gral. Univ. Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hosp. Univ. La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Hosp. Infanta Luisa

    Sevilla, 41010
    Spain

    Completed

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hacettepe Universitesi Hastanesi

    Ankara, 6230
    Turkey

    Active - Recruiting

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34390
    Turkey

    Site Not Available

  • Umraniye Training and Research Hospital

    Istanbul, 34766
    Turkey

    Active - Recruiting

  • Kocaeli University Medical Faculty

    Kocaeli, 41380
    Turkey

    Active - Recruiting

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Great Ormond Street Hospital

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Completed

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Sheffield, S1 0 2TH
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Haywood Hospital

    Staffordshire, ST6 7AG
    United Kingdom

    Active - Recruiting

  • Royal Stoke University Hospital

    Stoke on Trent, ST4 6QG
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Childrens Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095-3075
    United States

    Active - Recruiting

  • Nemours Children's Hospital/Endocrinology

    Orlando, Florida 32827
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637-1447
    United States

    Site Not Available

  • Harvard Medical School - Boston Children's Hospital

    Boston, Massachusetts 02215-5450
    United States

    Site Not Available

  • Harvard Medical School - Boston Children's Hospital

    Boston, Massachusetts 02215-5450
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467-2403
    United States

    Active - Recruiting

  • Northwell Health

    New York, New York 11040
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Metro Health Hospital

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Legacy Emanuel Medical Center

    Portland, Oregon 97227
    United States

    Terminated

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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