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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
5 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 weeks, 70 days, 140 days
  • Procedures mentioned: Injections, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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."
  • "The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for children with juvenile psoriatic arthritis (jPsA), which causes joint pain, stiffness, and swelling. It tests the safety of risankizumab, changes in symptoms, and how the drug moves through the body. Children receive either risankizumab or adalimumab as shots under the skin.

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. 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had jPsA diagnosed using standard medical rules for at least 3 months before screening.
  • Have at least 3 joints with active symptoms at screening and the start of treatment. Symptoms include swelling not caused by a change in joint shape, or limited movement with pain or tenderness.
  • Have tried at least one of these arthritis drugs: methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine. The drug either caused side effects you could not tolerate or did not work well enough after at least 2 months at the highest dose you could tolerate.

Who can't join

  • Have another disease where the immune system attacks the body, another rheumatic disease affecting joints or related tissues, or an overlap of these diseases. This includes other types of juvenile arthritis.
  • Previously had a poor response to an anti-TNF or IL-23 inhibitor, which are types of drugs that block signals causing inflammation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Prior inadequate response to treatments in the anti-TNF or IL-23 inhibitor classes.

Study sites (12)

AR

DC

FL

IN

MN

NC

NY

OH

TX