A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

A 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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis, Juvenile
• Intervention / Treatment: Drug: Ustekinumab; Drug: Guselkumab

Detailed Description

Juvenile psoriatic arthritis is a complex, chronic, progressive, debilitating musculoskeletal disease with significant remaining medical need. There is a need for medications which have a similar efficacy profile and a similar safety profile relative to currently available treatment for jPsA which include anti-tumor necrosis factor alpha (TNF alpha) inhibitors and secukinumab. STELARA (ustekinumab) is a fully human immunoglobulin G (IgG) 1 kappa monoclonal antibody (mAb) which binds with high affinity to the p40 subunit common to both interleukin (IL)-12 and IL 23 preventing IL-12/23p40 binding to the IL 12 Rb1 cell surface receptor shared by both cytokines. Through this mechanism of action, ustekinumab effectively neutralizes IL-12 T helper 1- and IL-23 T helper 17-mediated cellular responses. TREMFYA (guselkumab) is a fully human IgG1 lambda (G1 lambda) mAb that binds to the p19 subunit of human IL-23 with high affinity. The binding of guselkumab to IL-23 blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-specific intracellular signaling and subsequent activation and cytokine production. This study consists of Screening period (up to 6 weeks), Treatment period (up to 52 weeks) and a final safety visit at Week 68. The total duration of the study is up to 68 weeks.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1013AAAB
    • STAT Research S A
  • Córdoba, Argentina, 5000
    • Hospital de Ninos de Cordoba
  • La Plata, Argentina, B1900
    • Instituto Medico Platense
  • Rosario, Argentina, S2000PBJ
    • Instituto CAICI
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro Medico Privado de Reumatologia
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus Universitetshospital
  • Odense, Denmark, 5000
    • Odense Universitets Hospital
• France
  • Caen, France, 14033
    • CHU de Caen
  • Le Kremlin-Bicêtre, France, 94270
    • Hopital de Bicetre
  • Marseille, France, 13015
    • Hôpital Nord Marseille
  • Toulouse, France, 31059
    • CHU de Toulouse Hopital des Enfants
  • Vandœuvre-lès-Nancy, France, 54511
    • Hôpital D'Enfants
• Germany
  • Berlin, Germany, 13353
    • Charite Universitatsmedizin Berlin Campus Virchow Klinikum
  • Hamburg, Germany, 22081
    • Schon Klinik Hamburg Eilbek
  • Sankt Augustin, Germany, 53757
    • Asklepios Klinik Sankt Augustin
• Italy
  • Brescia, Italy, 25100
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
  • Genova, Italy, 16147
    • Istituto Giannina Gaslini
  • Milan, Italy, 20122
    • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Milan, Italy, 20122
    • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
  • Roma, Italy, 00165
    • IRCCS Ospedale Pediatrico Bambino Gesù
• Poland
  • Lodz, Poland, 91-738
    • CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej
  • Sosnowiec, Poland, 41 200
    • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
  • Warsaw, Poland, 02 637
    • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
• Spain
  • Barcelona, Spain, 8041
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08035
    • Hosp Univ Vall D Hebron
  • Córdoba, Spain, 14004
    • Hosp Reina Sofia
  • Santiago de Compostela, Spain, 15706
    • Hosp. Clinico Univ. de Santiago
  • Seville, Spain, 41010
    • Hosp. Infanta Luisa
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 6230
    • Hacettepe Universitesi Hastanesi
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 34766
    • Ümraniye Training and Research Hospital
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli University Medical Faculty
• United Kingdom
  • London, United Kingdom, WC1N 3JH
    • Great Ormond Street Hospital
  • Manchester, United Kingdom, M13 9WL
    • Royal Manchester Children's Hospital
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals Nhs Trust
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Staffordshire, United Kingdom, ST6 7AG
    • Haywood Hospital
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Royal Stoke University Hospital
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Childrens Hospital Los Angeles
    • Los Angeles, California, United States, 90095-3075
      • UCLA
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5450
      • Harvard Medical School - Boston Children's Hospital
  • New York
    • New York, New York, United States, 11040
      • Northwell Health
    • The Bronx, New York, United States, 10467-2403
      • Montefiore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Oregon
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.; Other Names: CNTO1959; TREMFYA
Experimental: 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.; Other Names: CNTO1275; STELARA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 28
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.	Week 28
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.	Week 28
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.	Week 28
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).	Week 24
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.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 52
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.	Week 52
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.	Baseline, up to Week 24
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.	Up to Week 68
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.	Up to Week 68
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.	Up to Week 68
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.	Week 52
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.	Week 52
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.	Weeks 4, 8, 12, 16 and 52
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.	Weeks 4, 8, 12, 16, 24, and 52
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.	Baseline, up to Weeks 4, 8, 12, 16, 24, and 52
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).	Baseline, up to Weeks 4, 8, 12, 16, 24, and 52
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.	Baseline and Week 24
Cohorts 1: Number of Participants with Antibodies to Ustekinumab	Number of participants with antibodies to ustekinumab (including peak titers) will be reported.	Weeks 52 and 68
Cohorts 2 : Number of Participants with Antibodies to Guselkumab	Number of participants with antibodies to guselkumab (including peak titers) will be reported.	Weeks 52 and 68

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): January 12, 2026
• Study Completion (Estimated): December 5, 2026

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Juvenile; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ustekinumab; guselkumab
• Other Study ID Numbers: CR109101; 2020-005503-40 (EudraCT Number); CNTO1275JPA3001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No