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New hope for kids with psoriatic arthritis: drug combo under trial

NCT ID NCT05083182

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study is testing two injectable drugs, ustekinumab and guselkumab, in 50 children with active juvenile psoriatic arthritis. The goal is to see how well the drugs work, how they move through the body, and if they are safe. Participants will receive one of the drugs and be monitored for about a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ustekinumab and guselkumab (biologic drugs given as injections)
What this could lead to
If successful, this study could show that these drugs are safe and effective for children with juvenile psoriatic arthritis, offering a new treatment option.
What could go wrong
This is an early-phase study with only 50 children, so results may not apply to everyone. The drugs can have side effects like increased risk of infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

48 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

juvenile idiopathic arthritis psoriasis-related juvenile idiopathic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis, juvenile

Contacts and locations

Locations

  • Aarhus Universitetshospital

    Aarhus, 8200, Denmark

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin, 53757, Germany

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

    Brescia, 25100, Italy

  • CHU de Caen

    Caen, 14033, France

  • CHU de Toulouse Hopital des Enfants

    Toulouse, 31059, France

  • CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej

    Lodz, 91-738, Poland

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, T4000AXL, Argentina

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

    Milan, 20122, Italy

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

    Sosnowiec, 41 200, Poland

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353, Germany

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Great Ormond Street Hospital

    London, WC1N 3JH, United Kingdom

  • Hacettepe Universitesi Hastanesi

    Ankara, 6230, Turkey (Türkiye)

  • Harvard Medical School - Boston Children's Hospital

    Boston, Massachusetts, 02215-5450, United States

  • Haywood Hospital

    Staffordshire, ST6 7AG, United Kingdom

  • Hopital Nord Marseille

    Marseille, 13015, France

  • Hopital de Bicetre

    Le Kremlin-Bicêtre, 94270, France

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706, Spain

  • Hosp. Infanta Luisa

    Seville, 41010, Spain

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 8041, Spain

  • Hospital de Ninos de Cordoba

    Córdoba, 5000, Argentina

  • Hôpital D'Enfants

    Vandœuvre-lès-Nancy, 54511, France

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165, Italy

  • Instituto Caici

    Rosario, S2000PBJ, Argentina

  • Instituto Medico Platense

    La Plata, B1900, Argentina

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Giannina Gaslini

    Genova, 16147, Italy

  • Kocaeli University Medical Faculty

    Kocaeli, 41380, Turkey (Türkiye)

  • Legacy Emanuel Medical Center

    Portland, Oregon, 97227, United States

  • Montefiore Medical Center

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

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

    Warsaw, 02 637, Poland

  • Northwell Health

    New York, New York, 11040, United States

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH, United Kingdom

  • Odense Universitets Hospital

    Odense, 5000, Denmark

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL, United Kingdom

  • Royal Stoke University Hospital

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

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • STAT Research S A

    Ciudad Autonoma Buenos Aires, C1013AAAB, Argentina

  • Schon Klinik Hamburg Eilbek

    Hamburg, 22081, Germany

  • Sheffield Children's Hospital

    Sheffield, S10 2TH, United Kingdom

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • UCLA

    Los Angeles, California, 90095-3075, United States

  • Umraniye Training and Research Hospital

    Istanbul, 34766, Turkey (Türkiye)

  • University of North Carolina

    Chapel Hill, North Carolina, 27514, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.