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Arthritis, JuvenilePhase 3PSUMMIT-JrNCT05083182

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

A Phase 3 study testing Ustekinumab and Guselkumab in people with Arthritis, Juvenile, run by Janssen Research & Development, LLC at 50 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Arthritis, Juvenile
What is being tested?
Ustekinumab and Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
50 sitesin 10 countries
Study dates
30 Aug 2022to 23 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

50 sites in 10 countries.

50 sites in 10 countries

United States9 sites

  • Harvard Medical School - Boston Children's Hospital

    Boston, Massachusetts, 02215-5450

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

  • UCLA

    Los Angeles, California, 90095-3075

  • Northwell Health

    New York, New York, 11040

  • Legacy Emanuel Medical Center

    Portland, Oregon, 97227

  • University of Utah

    Salt Lake City, Utah, 84132

  • Montefiore Medical Center

    The Bronx, New York, 10467-2403

Other trials in United States

United Kingdom8 sites

  • Great Ormond Street Hospital

    London, WC1N 3JH

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • Sheffield Children's Hospital

    Sheffield, S10 2TH

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Haywood Hospital

    Staffordshire, ST6 7AG

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Spain6 sites

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 8041

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Hosp. Infanta Luisa

    Seville, 41010

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Argentina5 sites

  • STAT Research S A

    Ciudad Autonoma Buenos Aires, C1013AAAB

  • Hospital de Ninos de Cordoba

    Córdoba, 5000

  • Instituto Medico Platense

    La Plata, B1900

  • Instituto Caici

    Rosario, S2000PBJ

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

France5 sites

  • CHU de Caen

    Caen, 14033

  • Hopital de Bicetre

    Le Kremlin-Bicêtre, 94270

  • Hopital Nord Marseille

    Marseille, 13015

  • CHU de Toulouse Hopital des Enfants

    Toulouse, 31059

  • Hôpital D'Enfants

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy5 sites

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

    Brescia, 25100

  • Istituto Giannina Gaslini

    Genova, 16147

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

    Milan, 20122

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165

Other trials in Italy

Turkey (Türkiye)4 sites

  • Hacettepe Universitesi Hastanesi

    Ankara, 6230

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Umraniye Training and Research Hospital

    Istanbul, 34766

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Germany3 sites

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353

  • Schon Klinik Hamburg Eilbek

    Hamburg, 22081

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin, 53757

Other trials in Germany

Poland3 sites

  • CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej

    Lodz, 91-738

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

    Sosnowiec, 41 200

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

    Warsaw, 02 637

Other trials in Poland

Denmark2 sites

  • Aarhus Universitetshospital

    Aarhus, 8200

  • Odense Universitets Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: 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).

Being tested
Ustekinumab, Guselkumab
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UstekinumabDrug

    Also called CNTO1275, STELARA

    Ustekinumab will be administered as subcutaneous injection.

  • GuselkumabDrug

    Also called CNTO1959, TREMFYA

    Guselkumab will be administered as subcutaneous injection.

Study groups in NCT05083182
Study groupRoleWhat they receive
Cohort 1: UstekinumabExperimentalParticipants 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.
Receives: Drug: Ustekinumab
Cohort 2: GuselkumabExperimentalThe 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.
Receives: Drug: Guselkumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 28

  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.

    Measured: Week 28

  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.

    Measured: Week 28

  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.

    Measured: Week 28

  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).

    Measured: Week 24

  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.

    Measured: Week 24

Secondary outcomes (15)

  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.

    Measured: Week 52

  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.

    Measured: Week 52

  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.

    Measured: Week 52

  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.

    Measured: Week 52

  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.

    Measured: Weeks 4, 8, 12, 16 and 52

  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.

    Measured: Weeks 4, 8, 12, 16, 24, and 52

  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.

    Measured: Baseline, up to Week 24

  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.

    Measured: Baseline, up to Weeks 4, 8, 12, 16, 24, and 52

  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).

    Measured: Baseline, up to Weeks 4, 8, 12, 16, 24, and 52

  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.

    Measured: Baseline and Week 24

  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.

    Measured: Up to Week 68

  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.

    Measured: Up to Week 68

  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.

    Measured: Up to Week 68

  14. Cohorts 1: Number of Participants with Antibodies to Ustekinumab

    Number of participants with antibodies to ustekinumab (including peak titers) will be reported.

    Measured: Weeks 52 and 68

  15. Cohorts 2 : Number of Participants with Antibodies to Guselkumab

    Number of participants with antibodies to guselkumab (including peak titers) will be reported.

    Measured: Weeks 52 and 68

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2021
  2. Study start30 Aug 2022
  3. Primary completion12 Jan 2026
  4. Study completion23 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05083182
Sponsor's protocol ID
CR109101
Other IDs
CNTO1275JPA3001, 2020-005503-40
Acronym
PSUMMIT-Jr
Status last verified
Jul 2026
First submitted
8 Oct 2021
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab and Guselkumab in people with Arthritis, Juvenile, run by Janssen Research & Development, LLC at 50 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, United Kingdom, Spain, Argentina, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups (time frame: Week 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05083182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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