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

NCT05083182 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: CR109101CNTO1275JPA30012020-005503-40
• Study Type: interventional
• Target: 50
• Locations: 10 countries
• Sites: 50

Brief 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).

Conditions

Arthritis, Juvenile

Outcome Measures

Primary Outcomes (6)

• 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: 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: 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 Outcomes (15)

• Cohorts 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 52 by Baseline Age Groups

  Week 52

• Cohorts 2: Steady-state Trough Serum Concentration of Guselkumabat at Week 52 by Baseline Age Groups

  Week 52

• Cohort 1: AUCss 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

  Week 52

• Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 30 Response at Weeks 4, 8, 12, 16, and 52

  Weeks 4, 8, 12, 16 and 52

Study Arms (2)

Cohort 1: Ustekinumab

EXPERIMENTAL

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

Cohort 2: Guselkumab

EXPERIMENTAL

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

Interventions

Ustekinumab DRUG

Ustekinumab will be administered as subcutaneous injection.

Also known as: CNTO1275, STELARA

Cohort 1: Ustekinumab

Guselkumab DRUG

Guselkumab will be administered as subcutaneous injection.

Also known as: CNTO1959, TREMFYA

Cohort 2: Guselkumab

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (50)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

UCLA

Los Angeles, California, 90095-3075, United States

Location

Harvard Medical School - Boston Children's Hospital

Boston, Massachusetts, 02215-5450, United States

Location

Northwell Health

New York, New York, 11040, United States

Location

Montefiore Medical Center

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

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Legacy Emanuel Medical Center

Portland, Oregon, 97227, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

STAT Research S A

Ciudad Autonoma Buenos Aires, C1013AAAB, Argentina

Location

Hospital de Ninos de Cordoba

Córdoba, 5000, Argentina

Location

Instituto Medico Platense

La Plata, B1900, Argentina

Location

Instituto Caici

Rosario, S2000PBJ, Argentina

Location

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, T4000AXL, Argentina

Location

Aarhus Universitetshospital

Aarhus, 8200, Denmark

Location

Odense Universitets Hospital

Odense, 5000, Denmark

Location

CHU de Caen

Caen, 14033, France

Location

Hopital de Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

Hopital Nord Marseille

Marseille, 13015, France

Location

CHU de Toulouse Hopital des Enfants

Toulouse, 31059, France

Location

Hôpital D'Enfants

Vandœuvre-lès-Nancy, 54511, France

Location

Charite Universitatsmedizin Berlin Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Schon Klinik Hamburg Eilbek

Hamburg, 22081, Germany

Location

Asklepios Klinik Sankt Augustin

Sankt Augustin, 53757, Germany

Location

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

Brescia, 25100, Italy

Location

Istituto Giannina Gaslini

Genova, 16147, Italy

Location

Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

Milan, 20122, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

Location

CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej

Lodz, 91-738, Poland

Location

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

Sosnowiec, 41 200, Poland

Location

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

Warsaw, 02 637, Poland

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 8041, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Infanta Luisa

Seville, 41010, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Hacettepe Universitesi Hastanesi

Ankara, 6230, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Umraniye Training and Research Hospital

Istanbul, 34766, Turkey (Türkiye)

Location

Kocaeli University Medical Faculty

Kocaeli, 41380, Turkey (Türkiye)

Location

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Haywood Hospital

Staffordshire, ST6 7AG, United Kingdom

Location

Royal Stoke University Hospital

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

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Ustekinumab; guselkumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 19, 2021
• Study Start: August 30, 2022
• Primary Completion: January 12, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AR (5); TU (4); GB (8); US (9); PL (3); DK (2); DE (3); IT (5); FR (5); ES (6)