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

Last updated: April 23, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Psoriatic Arthritis

Joint Injuries

Treatment

Risankizumab

Adalimumab

Clinical Study ID

NCT06100744
M23-732
2023-506026-36-00
  • Ages 5-18
  • All Genders

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of juvenile psoriatic arthritis (jPsA) according to International Leagueof Associations for Rheumatology criteria for at least 6 months prior to screening.

  • Active Disease in >= 3 joints at screening and at Baseline (swelling not due todeformity, or limitation of motion with pain, tenderness, or both) are eligible forinclusion in the study.

  • Have had an inadequate response (lack of efficacy after minimum 2-month duration oftherapy at maximally tolerated dose), or intolerance to previous or currenttreatment with at least 1 of the following conventional synthetic disease-modifyingantirheumatic drug (csDMARDs): methotrexate (MTX), sulfasalazine, leflunomide, orhydroxychloroquine.

Exclusion

Exclusion Criteria:

  • Have any other autoimmune disease, rheumatic disease (including systemic Juvenileidiopathic arthritis [JIA], rheumatoid factor-positive or rheumatoid factor-negativepolyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA,enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome.

  • Prior inadequate response to drugs in the anti-TNF, IL-23 inhibitor, and IL-12/23inhibitor classes.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Risankizumab
Phase: 3
Study Start date:
July 08, 2024
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • Monash Health - Monash Medical Centre /ID# 260255

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 260255

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Alberta Children's Hospital /ID# 257880

    Calgary, Alberta T3B 6A8
    Canada

    Active - Recruiting

  • British Columbia Children and Women's Hospital and Health Centre /ID# 257884

    Vancouver, British Columbia V6H 3N1
    Canada

    Active - Recruiting

  • CHU Bordeaux - Hopital Pellegrin /ID# 258729

    Bordeaux, Nouvelle-Aquitaine 33076
    France

    Active - Recruiting

  • AP-HP - Hopital Bicetre /ID# 258728

    Le Kremlin Bicetre, Paris 94270
    France

    Active - Recruiting

  • AP-HP - Hôpital Bicêtre /ID# 258728

    Le Kremlin Bicetre, 94270
    France

    Active - Recruiting

  • Asklepios Klinik Sankt Augustin /ID# 259106

    Sankt Augustin, Nordrhein-Westfalen 53757
    Germany

    Active - Recruiting

  • Helios Klinikum Berlin - Buch /ID# 268803

    Berlin, 13125
    Germany

    Active - Recruiting

  • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104

    Hamburg, 22081
    Germany

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Meyer /ID# 258587

    Florence, Firenze 50139
    Italy

    Active - Recruiting

  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785

    Lodz, Lodzkie 91-738
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781

    Lublin, Lubelskie 20-093
    Poland

    Active - Recruiting

  • Malopolskie Badania Kliniczne /ID# 258777

    Cracow, Malopolskie 30-002
    Poland

    Active - Recruiting

  • Małopolskie Badania Kliniczne /ID# 258777

    Cracow, Malopolskie 30-002
    Poland

    Active - Recruiting

  • Hospital Sant Joan de Deu /ID# 257568

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

  • Hospital Universitario y Politecnico La Fe /ID# 257567

    Valencia, 46026
    Spain

    Active - Recruiting

  • Sheffield Children's Hospital NHS Foundation Trust /ID# 258848

    Sheffield, England S10 2TH
    United Kingdom

    Active - Recruiting

  • University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847

    Bristol, BS2 8BJ
    United Kingdom

    Active - Recruiting

  • Alder Hey Children's NHS Foundation Trust /ID# 262770

    Liverpool, L14 5AB
    United Kingdom

    Active - Recruiting

  • Arkansas Children's Hospital /ID# 258776

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Children's National Medical Center /ID# 259284

    Washington, District of Columbia 20010-2916
    United States

    Active - Recruiting

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

    Hollywood, Florida 33021
    United States

    Active - Recruiting

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

    Hollywood, Florida 33021
    United States

    Site Not Available

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

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Riley Hospital for Children /ID# 259067

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

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

    Minneapolis, Minnesota 55454
    United States

    Active - Recruiting

  • Boston Childrens Health Physicians /ID# 258061

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • UNC Children's Hospital /ID# 259286

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • UNC Hospitals Children's Specialty Clinic /ID# 259286

    Chapel Hill, North Carolina 27514-4220
    United States

    Active - Recruiting

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

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • MetroHealth Medical Center /ID# 262377

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • Child Neurology Consultants of Austin /ID# 260562

    Austin, Texas 78757-7571
    United States

    Active - Recruiting

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