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Efficacy, safety, tolerability, and pharmacokinetics of risankizumab in pediatric subjects with active juvenile psoriatic arthritis
EU CTIS ID: 2023-506026-36-00
What this study is testing
The primary study objective is to assess efficacy, safety, tolerability, and PK of risankizumab with an adalimumab reference arm in children and adolescent subjects aged 5 to < 18 years with active jPsA who have had an inadequate response to, or are intolerant of, methotrexate (MTX) or other csDMARDs.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects must have a diagnosis of jPsA according to ILAR 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). Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, limitation of motion with pain or tenderness or both meet the criteria for an active arthritic joint.
- Subject must have demonstrated 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 csDMARDs: MTX, sulfasalazine, leflunomide, or hydroxychloroquine.
You likely can't join if
- Subjects have any other autoimmune disease, rheumatic disease (including systemic 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Australia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Australia; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.