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

Last updated: December 18, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Psoriatic Arthritis

Joint Injuries

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

    Site Not Available

  • STAT Research S.A.

    Ciudad Autonoma Buenos Aires, C1013AAAB
    Argentina

    Active - Recruiting

  • Hospital de Ninos de Cordoba

    Cordoba, 5000
    Argentina

    Active - Recruiting

  • Hospital de Ninos de Cordoba

    Córdoba 3860259, 5000
    Argentina

    Site Not Available

  • Instituto Medico Platense

    La Plata, B1900
    Argentina

    Site Not Available

  • Instituto Medico Platense

    La Plata 3432043, B1900
    Argentina

    Site Not Available

  • Instituto Caici

    Rosario, S2000PBJ
    Argentina

    Site Not Available

  • Instituto Caici

    Rosario 3838583, S2000PBJ
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    San Miguel De Tucuman, T4000AXL
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán 3836873, T4000AXL
    Argentina

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus 2624652, 8200
    Denmark

    Site Not Available

  • Aarhus Universitetshospital

    Arhus, 8200
    Denmark

    Site Not Available

  • Odense Universitets Hospital

    Odense, 5000
    Denmark

    Site Not Available

  • Odense Universitets Hospital

    Odense 2615876, 5000
    Denmark

    Site Not Available

  • CHU de Caen

    Caen, 14033
    France

    Site Not Available

  • CHU de Caen

    Caen 3029241, 14033
    France

    Site Not Available

  • Hopital de Bicetre

    Le Kremlin Bicêtre, 94270
    France

    Site Not Available

  • Hopital de Bicetre

    Le Kremlin-Bicêtre 3003737, 94270
    France

    Site Not Available

  • Hopital Nord - Marseille

    Marseille, 13015
    France

    Active - Recruiting

  • Hopital Nord Marseille

    Marseille, 13015
    France

    Site Not Available

  • Hopital Nord Marseille

    Marseille 2995469, 13015
    France

    Site Not Available

  • CHU de Toulouse Hopital des Enfants

    Toulouse 2972315, 31059
    France

    Site Not Available

  • CHU de Toulouse Hopital des Enfants

    Toulouse cedex 9, 31059
    France

    Site Not Available

  • Hôpital D'Enfants

    Vandoeuvre les Nancy, 54511
    France

    Site Not Available

  • Hôpital D'Enfants

    Vandœuvre-lès-Nancy 2970797, 54511
    France

    Site Not Available

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Active - Recruiting

  • Helios Kliniken Berlin Buch Gmbh

    Berlin, 13125
    Germany

    Site Not Available

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum

    Berlin 2950159, 13353
    Germany

    Site Not Available

  • Schon Klinik Hamburg Eilbek

    Hamburg, 22081
    Germany

    Site Not Available

  • Schön Klinik Hamburg Eilbek

    Hamburg, 22081
    Germany

    Site Not Available

  • Schon Klinik Hamburg Eilbek

    Hamburg 2911298, 22081
    Germany

    Site Not Available

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin, 53757
    Germany

    Site Not Available

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin 2841648, 53757
    Germany

    Site Not Available

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

    Brescia, 25100
    Italy

    Site Not Available

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

    Brescia 3181554, 25100
    Italy

    Site Not Available

  • Istituto Giannina Gaslini

    Genova, 16147
    Italy

    Site Not Available

  • Istituto Giannina Gaslini

    Genova 8969657, 16147
    Italy

    Site Not Available

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

    Milan 6951411, 20122
    Italy

    Site Not Available

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan 6951411, 20122
    Italy

    Site Not Available

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

    Milano, 20122
    Italy

    Site Not Available

  • 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

    Site Not Available

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma 8957247, 00165
    Italy

    Site Not Available

  • 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

    Site Not Available

  • CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej

    Lodz 3093133, 91-738
    Poland

    Site Not Available

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

    Sosnowiec, 41 200
    Poland

    Site Not Available

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

    Sosnowiec 3085128, 41 200
    Poland

    Site Not Available

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

    Warsaw 756135, 02 637
    Poland

    Site Not Available

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

    Warszawa, 02 637
    Poland

    Site Not Available

  • 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

    Site Not Available

  • Hosp. Univ. Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 8041
    Spain

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona 3128760, 8041
    Spain

    Site Not Available

  • Hosp Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hosp. Reina Sofia

    Cordoba, 14004
    Spain

    Active - Recruiting

  • Hosp Reina Sofia

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • 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

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela 3109642, 15706
    Spain

    Site Not Available

  • Hosp. Infanta Luisa

    Sevilla, 41010
    Spain

    Site Not Available

  • Hosp. Infanta Luisa

    Seville 2510911, 41010
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Hacettepe Universitesi Hastanesi

    Ankara, 6230
    Turkey

    Site Not Available

  • 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

    Site Not Available

  • Hacettepe Universitesi Hastanesi

    Ankara 323786, 6230
    Turkey (Türkiye)

    Site Not Available

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul 745044, 34098
    Turkey (Türkiye)

    Site Not Available

  • Umraniye Training and Research Hospital

    Istanbul 745044, 34766
    Turkey (Türkiye)

    Site Not Available

  • Kocaeli University Medical Faculty

    Kocaeli 306970, 41380
    Turkey (Türkiye)

    Site Not Available

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Great Ormond Street Hospital

    London, WC1N 3JH
    United Kingdom

    Site Not Available

  • Great Ormond Street Hospital

    London 2643743, WC1N 3JH
    United Kingdom

    Site Not Available

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Royal Manchester Children's Hospital

    Manchester 2643123, M13 9WL
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle upon Tyne 2641673, NE1 4LP
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust

    Nottingham 2641170, NG7 2UH
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield 2638077, S10 2TH
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton 2637487, SO16 6YD
    United Kingdom

    Site Not Available

  • Haywood Hospital

    Staffordshire, ST6 7AG
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke on Trent, ST4 6QG
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent 2636841, ST4 6QG
    United Kingdom

    Site Not Available

  • 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

    Site Not Available

  • Childrens Hospital Los Angeles

    Los Angeles 5368361, California 5332921 90027
    United States

    Site Not Available

  • UCLA

    Los Angeles 5368361, California 5332921 90095-3075
    United States

    Site Not Available

  • 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

    Site Not Available

  • Harvard Medical School - Boston Children's Hospital

    Boston 4930956, Massachusetts 6254926 02215-5450
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467-2403
    United States

    Site Not Available

  • Northwell Health

    New York, New York 11040
    United States

    Site Not Available

  • Northwell Health

    New York 5128581, New York 5128638 11040
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467-2403
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Metro Health Hospital

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • Legacy Emanuel Medical Center

    Portland, Oregon 97227
    United States

    Site Not Available

  • Legacy Emanuel Medical Center

    Portland 5746545, Oregon 5744337 97227
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 84132
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.