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Taking people in ItalyPhase 3

Tests risankizumab against adalimumab in children with juvenile psoriatic arthritis

Compares risankizumab injections with adalimumab in children with juvenile psoriatic arthritis.

Key facts

Who runs it
AbbVie
Where
Florence, Milan, and Rome, ItalySee the 3 sitesAlso in 8 other countries, 31 sites
Registry title
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
Status
Recruiting
Phase
Phase 3
People taking part
40 people, planned
Started
8 Jul 2024
Expected to end
Oct 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Adalimumab
  • Risankizumab
Record updated
1 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with active juvenile psoriatic arthritis who did not do well on, or could not tolerate, earlier arthritis medicines.

Age
5 Years to 17 Years
Sex
All sexes can join.
Disease stage
Juvenile psoriatic arthritis diagnosed at least 3 months before screening, with active disease in at least 3 joints at screening and at Baseline.
Earlier treatment
Must have had an inadequate response or intolerance to at least 1 of these: methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine. Must not have had an inadequate response to anti-TNF or IL-23 inhibitor treatments.

Main reasons for not taking part

  • Any other autoimmune or rheumatic disease, or overlap syndrome
  • Other types of juvenile idiopathic arthritis
  • Earlier inadequate response to anti-TNF or IL-23 inhibitor treatments

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 months prior to screening
  • Active Disease in >= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study
  • Have had an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose), or intolerance to previous or current treatment with at least 1 of the following conventional synthetic disease-modifying antirheumatic drug (csDMARDs): methotrexate (MTX), sulfasalazine, leflunomide, or hydroxychloroquine

Who cannot take part

  • Prior inadequate response to treatments in the anti-TNF or IL-23 inhibitor classes
  • Have any other autoimmune disease, rheumatic disease (including systemic Juvenile idiopathic arthritis [JIA], rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 5 and 17 years old?

Where in Italy

Also in 8 other countries, 31 sites

  • Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyTaking people
  • Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini CtoMilan, ItalyTaking people
  • Bambino Gesu Childrens HospitalRome, ItalyTaking people

About the trial

What the trial wants to find out

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms.

Read full original descriptionShow less

Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide.

Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

The 2 groups in the trial

  • RisankizumabTreatment being tested

    Participants will receive risankizumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 140 day safety follow up after the treatment period.

  • AdalimumabTreatment being tested

    Participants will receive adalimumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 70 day safety follow up after the treatment period.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis
Plain-language title
Tests risankizumab against adalimumab in children with juvenile psoriatic arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06100744, who can take part
Record updated
1 September 2026