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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

AbbVie · NCT06100744

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 5–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
40
US sites recruiting
12
Study start
July 8, 2024
Record last updated
September 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.

Being studied: Adalimumab; Risankizumab

Conditions: Juvenile Psoriatic Arthritis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Arkansas Children's Hospital /ID# 258776

    Little Rock, AR 72202

    Site contact: Site Coordinator · 501-364-3686

  • Childrens National Medical Center /ID# 259284

    Washington D.C., DC 20010-2916

    Site contact: Site Coordinator · qyu@childrensnational.org

  • Joe Dimaggio Children's Hospital Hollywood /ID# 260634

    Hollywood, FL 33021

    Site contact: Site Coordinator · 954-265-4466

  • All X Ray Diagnostic Services Corp /ID# 278523

    Miami, FL 33126

    Site contact: Site Coordinator · (305) 445-9462 · thalialopez@allxray.com

  • Indiana University Health Riley Hospital for Children /ID# 259067

    Indianapolis, IN 46202

  • M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111

    Minneapolis, MN 55454

    Site contact: Site Coordinator · rheum-research@umn.edu

  • Columbia University Medical Center /ID# 262587

    New York, NY 10032-3729

    Site contact: Site Coordinator · 212-305-4308

  • Boston Childrens Health Physicians /ID# 258061

    Valhalla, NY 10595

    Site contact: Site Coordinator · 914-504-0152

  • University of North Carolina - Children's Hospital /ID# 259286

    Chapel Hill, NC 27514

    Site contact: Site Coordinator · 919-504-6650

  • MetroHealth Medical Center /ID# 262377

    Cleveland, OH 44109

  • Cleveland Clinic - Cleveland /ID# 276655

    Cleveland, OH 44195

  • Child Neurology Consultants of Austin /ID# 260562

    Austin, TX 78757-7571

    Site contact: Site Coordinator · 512-494-4000

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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A Study to Assess Adverse Events, Change in Disease Activity, and… (NCT06100744) | Bored Studies