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Assessing the safety and effectiveness of risankizumab and adalimumab in children with juvenile psoriatic arthritis

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

Phase 3 Interventional AbbVie · NCT06100744

This study is testing a new medication called risankizumab to see if it works better and is safer than the standard treatment adalimumab for children with juvenile psoriatic arthritis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment40 (estimated)
Ages5 Years to 17 Years
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsmethotrexate, risankizumab, adalimumab
Locations32 sites (Little Rock, Arkansas and 31 other locations)
Trial IDNCT06100744 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of risankizumab, a new treatment, compared to the established treatment adalimumab in children diagnosed with juvenile psoriatic arthritis (jPsA). Participants will be randomly assigned to receive either medication through subcutaneous injections based on their body weight. The study aims to assess adverse events, changes in disease activity, and how the drug is processed in the body. Approximately 40 juvenile participants will be enrolled across 30 sites worldwide, focusing on those with active disease in multiple joints.

Who should consider this trial

Good fit: Ideal candidates for this study are children diagnosed with juvenile psoriatic arthritis who have had an inadequate response to previous treatments.

Not a fit: Patients with other autoimmune or rheumatic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for children suffering from juvenile psoriatic arthritis.

How similar studies have performed: Other studies have shown success with similar biologic treatments for juvenile psoriatic arthritis, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Little Rock, Arkansas and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Juvenile Psoriatic ArthritisPsoriatic ArthritisRisankizumabABBV-066Adalimumab
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.