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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT05083182
Other Study ID Numbers:
CR109101
First Submitted
October 7, 2021
First Posted
October 18, 2021
Last Update Posted
April 12, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Arthritis, Juvenile
Drug: UstekinumabDrug: Guselkumab

Study Design

Study TypeInterventional
Actual Enrollment50 participants
Design AllocationNon-Randomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)
Study Start DateAugust 29, 2022
Actual Primary Completion DateJanuary 11, 2026
Actual Study Completion Date6mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Cohort 1: Ustekinumab
Participants will receive a weight-based dose of ustekinumab subcutaneously (SC) at Week 0, Week 4 and then every 12 weeks up to Week 52. Cohort 1 is closed for further enrollment.
Drug: Ustekinumab
Ustekinumab will be administered as subcutaneous injection.
Cohort 2: Guselkumab
The dose of guselkumab will be based on the participant's weight. Participants will receive guselkumab SC at Weeks 0 and 4 followed by either every 4 weeks (Q4W) (with historical radiographic evidence of joint damage) or every 8 weeks (Q8W) (without historical evidence of joint damage) dosing with the last dose at Week 52. Participants at high risk of joint damage can also be considered for Q4W dosing per investigator.
Drug: Guselkumab
Guselkumab will be administered as subcutaneous injection.

Outcome Measures

Primary Outcome Measures
  1. Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups
    Steady-state trough serum concentration of ustekinumab at Week 28 by baseline age groups will be reported.
  2. Cohort 2: Steady-state Trough Serum Concentration of Guselkumab at Week 28 by Baseline Age Groups
    Steady-state trough serum concentration of guselkumab at Week 28 by baseline age groups will be reported.
  3. Cohort 1: Area Under the Curve at Steady-state (AUCss) Over a 12-Week Dosing Interval of Ustekinumab at Week 28 by Baseline Age Groups
    AUCss is defined as area under the curve at steady-state over a 12-week dosing interval of ustekinumab at Week 28 by baseline age groups.
  4. Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 28 by Baseline Age Groups
    AUCss is defined as area under the curve at steady-state over a dosing interval (4 or 8 weeks) of guselkumab at Week 28 by baseline age groups.
  5. Cohort 1: Percentage of Participants with Juvenile Psoriatic Arthritis (jPsA) Achieving American College of Rheumatology (ACR) Pediatric 30 Response at Week 24
    Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30 percent (%) improvement (that is, a decrease in score) from baseline in greater than or equal to (\>=) 3 of the following 6 components, with worsening of \>=30% in no more than 1 of the following components: physician global assessment (PGA) of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by childhood health assessment questionnaire (CHAQ) and C-reactive protein (CRP).
  6. Cohort 2: Percentage of Participants with jPsA Achieving ACR Pediatric 30 Response at Week 24
    Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30% improvement (that is, a decrease in score) from baseline in \>=3 of the following 6 components, with worsening of \>=30% in no more than 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP.
Secondary Outcome Measures
  1. Cohorts 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 52 by Baseline Age Groups
    Steady-state trough serum concentration of ustekinumab at Week 52 by baseline age groups will be reported.
  2. Cohorts 2: Steady-state Trough Serum Concentration of Guselkumabat at Week 52 by Baseline Age Groups
    Steady-state trough serum concentration of guselkumab at Week 52 by baseline age groups will be reported.
  3. Cohort 1: AUCss Over a 12-Week Dosing Interval of Ustekinumab at Week 52 by Baseline Age Groups
    AUCss is defined as area under the curve at steady-state over a 12-week dosing interval of ustekinumab at Week 52 by baseline age groups.
  4. Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 52 by Baseline Age Groups
    AUCss is defined as area under the curve at steady-state over a dosing interval (4 or 8 weeks) of guselkumab at Week 52 by baseline age groups.
  5. Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 30 Response at Weeks 4, 8, 12, 16, and 52
    The ACR pediatric 30 response criteria is defined as a 30% improvement (that is, a decrease in score) from baseline in \>=3 of the following 6 components, with worsening of \>=30% in no more than 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP.
  6. Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 50 and 70 Responses at Weeks 4, 8, 12, 16, 24, and 52
    The ACR pediatric 50 and 70 responses are defined as a 50% improvement or 70% improvement (that is, a decrease in score) from baseline in \>=3 of the following 6 components, with worsening of \>=30% in no more than 1 of the following components: 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP.
  7. Cohorts 1 and 2: Time to Response Measured as Time to Achieving ACR Pediatric 30
    Time to response measured as time to achieving ACR pediatric 30 will be reported.
  8. Cohorts 1 and 2: Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS) 10 at Weeks 4, 8, 12, 16, 24, and 52
    Change from baseline in cJADAS 10 at Weeks 4, 8, 12, 16, 24, and 52 will be reported. The cJADAS is calculated as the sum of the scores of its 3 components: (1) physician global rating of overall disease activity, measured on a 10-cm horizontal visual analog scale; (2) parent/child ratings of well-being, assessed on a 10 cm horizontal line VAS; (3) number of active joints, assessed in 10 joints, for a total score ranging from 0 to 30 where 0=no activity and 30=maximum activity.
  9. Cohorts 1 and 2: Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) 10, 27 and 71 at Weeks 4, 8, 12, 16, 24, and 52
    Change from baseline in JADAS 10, 27 and 71 at Weeks 4, 8, 12, 16, 24, and 52 will be reported. The JADAS is calculated as the sum of the scores of its 4 components: (1) physician global rating of overall disease activity, measured on a 10-cm horizontal visual analog scale; (2) parent/child ratings of well-being, assessed on a 10 cm horizontal line VAS; (3) number of active joints, assessed in 71, 27, or 10 joints (for JADAS 71, JADAS 27, and JADAS 10, respectively); (4) CRP (truncated to 0-10 mg/dL).
  10. Cohorts 1 and 2: Change from Baseline in Psoriasis Area Severity Index (PASI) Score at Week 24
    Change from baseline in PASI score at Week 24 among the participants with greater than or equal to (\>=) 3% body surface area (BSA) psoriatic involvement and a PGA psoriasis score of \>=2 (mild) at baseline will be reported. The PASI includes assessments of 4 areas of the body: the head and neck, the arms, the trunk, and the legs. The percentage of skin in each area affected by psoriasis is given a numeric score representing the proportion involved. The severity of the 3 plaque signs of erythema, thickness/induration, and desquamation/scaling, is assessed on a 5-point scale. The total PASI score is from 0-72, where 0=no disease and 72=more disease.
  11. Cohorts 1 and 2: Percentage of Participants with Adverse Events (AEs)
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
  12. Cohorts 1 and 2: Percentage of Participants with Serious Adverse Events (SAEs)
    A SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
  13. Cohorts 1 and 2: Percentage of Participants with Reasonably Related AEs
    Percentage of participants with reasonably related AEs (including injection-site reactions and infections) will be reported.
  14. Cohorts 1: Number of Participants with Antibodies to Ustekinumab
    Number of participants with antibodies to ustekinumab (including peak titers) will be reported.
  15. Cohorts 2 : Number of Participants with Antibodies to Guselkumab
    Number of participants with antibodies to guselkumab (including peak titers) will be reported.

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion 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 and at 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 of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint
Have active disease despite previous non-biologic disease modifying anti-rheumatic drug (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 12 weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose
Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients
Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (except non-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficient washout period
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

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
Childrens Hospital Los Angeles | Los Angeles California, United States, 90027UCLA | Los Angeles California, United States, 90095-3075Harvard Medical School - Boston Children's Hospital | Boston Massachusetts, United States, 02215-5450Northwell Health | New York New York, United States, 11040Montefiore Medical Center | The Bronx New York, United States, 10467-2403University of North Carolina | Chapel Hill North Carolina, United States, 27514Cincinnati Children's Hospital Medical Center | Cincinnati Ohio, United States, 45229Legacy Emanuel Medical Center | Portland Oregon, United States, 97227University of Utah | Salt Lake City Utah, United States, 84132STAT Research S A | Ciudad Autonoma Buenos Aires , Argentina, C1013AAABHospital de Ninos de Cordoba | Córdoba , Argentina, 5000Instituto Medico Platense | La Plata , Argentina, B1900Instituto Caici | Rosario , Argentina, S2000PBJCentro Medico Privado de Reumatologia | San Miguel de Tucumán , Argentina, T4000AXLAarhus Universitetshospital | Aarhus , Denmark, 8200Odense Universitets Hospital | Odense , Denmark, 5000CHU de Caen | Caen , France, 14033Hopital de Bicetre | Le Kremlin-Bicêtre , France, 94270Hopital Nord Marseille | Marseille , France, 13015CHU de Toulouse Hopital des Enfants | Toulouse , France, 31059Hôpital D'Enfants | Vandœuvre-lès-Nancy , France, 54511Charite Universitatsmedizin Berlin Campus Virchow Klinikum | Berlin , Germany, 13353Schon Klinik Hamburg Eilbek | Hamburg , Germany, 22081Asklepios Klinik Sankt Augustin | Sankt Augustin , Germany, 53757Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili | Brescia , Italy, 25100Istituto Giannina Gaslini | Genova , Italy, 16147Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO | Milan , Italy, 20122Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan , Italy, 20122IRCCS Ospedale Pediatrico Bambino Gesu | Roma , Italy, 00165CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej | Lodz , Poland, 91-738Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o | Sosnowiec , Poland, 41 200Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher | Warsaw , Poland, 02 637Hosp Univ Vall D Hebron | Barcelona , Spain, 08035Hosp. de La Santa Creu I Sant Pau | Barcelona , Spain, 8041Hosp Reina Sofia | Córdoba , Spain, 14004Hosp. Clinico Univ. de Santiago | Santiago de Compostela , Spain, 15706Hosp. Infanta Luisa | Seville , Spain, 41010Hosp. Univ. I Politecni La Fe | Valencia , Spain, 46026Hacettepe Universitesi Hastanesi | Ankara , Turkey (Türkiye), 6230Istanbul University Cerrahpasa Medical Faculty | Istanbul , Turkey (Türkiye), 34098Umraniye Training and Research Hospital | Istanbul , Turkey (Türkiye), 34766Kocaeli University Medical Faculty | Kocaeli , Turkey (Türkiye), 41380Great Ormond Street Hospital | London , United Kingdom, WC1N 3JHRoyal Manchester Children's Hospital | Manchester , United Kingdom, M13 9WLRoyal Victoria Infirmary | Newcastle upon Tyne , United Kingdom, NE1 4LPNottingham University Hospitals NHS Trust | Nottingham , United Kingdom, NG7 2UHSheffield Children's Hospital | Sheffield , United Kingdom, S10 2THSouthampton General Hospital | Southampton , United Kingdom, SO16 6YDHaywood Hospital | Staffordshire , United Kingdom, ST6 7AGRoyal Stoke University Hospital | Stoke-on-Trent , United Kingdom, ST4 6QG
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC