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

Study Identifier
M23-732
CT.gov Identifier
NCT06100744
EudraCT Identifier
Not available
EUCTIS ID
2023-506026-36-00
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Immune & Inflammatory - Other
    • Study Drug
  • Adalimumab
  • Risankizumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    5 - 17 Years
    Inclusion and 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.

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Arkansas Children's Hospital /ID# 258776
    Little Rock, Arkansas, United States, 72202
    Status
    Recruiting
    Location
    Childrens National Medical Center /ID# 259284
    Washington D.C., District of Columbia, United States, 20010-2916
    Status
    Recruiting
    Location
    Joe Dimaggio Children's Hospital Hollywood /ID# 260634
    Hollywood, Florida, United States, 33021
    Status
    Recruiting
    Location
    Indiana University Health Riley Hospital for Children /ID# 259067
    Indianapolis, Indiana, United States, 46202
    Status
    Recruiting
    Location
    M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
    Minneapolis, Minnesota, United States, 55454
    Status
    Recruiting
    Location
    Columbia University Medical Center /ID# 262587
    New York, New York, United States, 10032-3729
    Status
    Recruiting
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