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: February 16, 2026
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 5-17
  • 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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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 3 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 treatments in the anti-TNF or IL-23 inhibitor 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

    Site Not Available

  • Monash Medical Centre /ID# 260255

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre /ID# 260255

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Active - Recruiting

  • Alberta Children's Hospital /ID# 257880

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • Alberta Children's Hospital /ID# 257880

    Calgary 5913490, Alberta 5883102 T3B 6A8
    Canada

    Active - Recruiting

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

    Vancouver, British Columbia V6H 3N1
    Canada

    Site Not Available

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

    Vancouver 6173331, British Columbia 5909050 V6H 3N1
    Canada

    Active - Recruiting

  • Hospital for Sick Children /ID# 257879

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Hospital for Sick Children /ID# 257879

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Active - Recruiting

  • CHU Bordeaux - Hopital Pellegrin /ID# 258729

    Bordeaux, Nouvelle-Aquitaine 33076
    France

    Site Not Available

  • CHU Bordeaux - Hopital Pellegrin /ID# 258729

    Bordeaux 3031582, Nouvelle-Aquitaine 11071620 33076
    France

    Active - Recruiting

  • AP-HP - Hopital Bicetre /ID# 258728

    Le Kremlin Bicetre, Paris 94270
    France

    Site Not Available

  • AP-HP - Hopital Bicetre /ID# 258728

    Le Kremlin-Bicêtre 3003737, 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

    Site Not Available

  • Asklepios Klinik Sankt Augustin /ID# 259106

    Sankt Augustin 2841648, North Rhine-Westphalia 2861876 53757
    Germany

    Active - Recruiting

  • Helios Klinikum Berlin - Buch /ID# 268803

    Berlin, 13125
    Germany

    Site Not Available

  • Helios Klinikum Berlin - Buch /ID# 268803

    Berlin 2950159, 13125
    Germany

    Active - Recruiting

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

    Hamburg, 22081
    Germany

    Site Not Available

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

    Hamburg 2911298, 22081
    Germany

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Meyer /ID# 258587

    Florence, Firenze 50139
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Meyer /ID# 258587

    Florence 3176959, Firenze 50139
    Italy

    Active - Recruiting

  • ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753

    Milan 3173435, Milano 20122
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù /ID# 258869

    Rome, Roma 00165
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù /ID# 258869

    Rome 3169070, Roma 00165
    Italy

    Active - Recruiting

  • Malopolskie Badania Kliniczne /ID# 258777

    Krakow 3094802, Lesser Poland Voivodeship 858786 30-002
    Poland

    Active - Recruiting

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

    Lodz, Lodzkie 91-738
    Poland

    Site Not Available

  • Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781

    Lublin, Lubelskie 20-093
    Poland

    Site Not Available

  • Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781

    Lublin 765876, Lublin Voivodeship 858785 20-093
    Poland

    Active - Recruiting

  • Malopolskie Badania Kliniczne /ID# 258777

    Cracow, Malopolskie 30-002
    Poland

    Site Not Available

  • Małopolskie Badania Kliniczne /ID# 258777

    Cracow, Malopolskie 30-002
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji /ID# 277050

    Warsaw 756135, Masovian Voivodeship 858787 02-637
    Poland

    Active - Recruiting

  • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058

    Sosnowiec 3085128, Silesian Voivodeship 3337497 41-200
    Poland

    Active - Recruiting

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

    Lodz 3093133, Łódź Voivodeship 3337493 91-738
    Poland

    Active - Recruiting

  • Hospital Sant Joan de Deu /ID# 257568

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • Hospital Sant Joan de Deu /ID# 257568

    Esplugues de Llobregat 3122826, Barcelona 08950
    Spain

    Active - Recruiting

  • Hospital Universitario y Politecnico La Fe /ID# 257567

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe /ID# 257567

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

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

    Sheffield, England S10 2TH
    United Kingdom

    Site Not Available

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

    Sheffield 2638077, England 6269131 S10 2TH
    United Kingdom

    Active - Recruiting

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

    Bristol, BS2 8BJ
    United Kingdom

    Site Not Available

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

    Bristol 2654675, BS2 8BJ
    United Kingdom

    Active - Recruiting

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

    Liverpool, L12 2AP
    United Kingdom

    Site Not Available

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

    Liverpool 2644210, L12 2AP
    United Kingdom

    Active - Recruiting

  • Arkansas Children's Hospital /ID# 258776

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Arkansas Children's Hospital /ID# 258776

    Little Rock 4119403, Arkansas 4099753 72202
    United States

    Active - Recruiting

  • Children's National Medical Center /ID# 259284

    Washington, District of Columbia 20010-2916
    United States

    Site Not Available

  • Childrens National Medical Center /ID# 259284

    Washington D.C. 4140963, District of Columbia 4138106 20010-2916
    United States

    Active - Recruiting

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

    Hollywood, Florida 33021
    United States

    Site Not Available

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

    Hollywood, Florida 33021
    United States

    Site Not Available

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

    Hollywood 4158928, Florida 4155751 33021
    United States

    Active - Recruiting

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

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Riley Hospital for Children /ID# 259067

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

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

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

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

    Minneapolis, Minnesota 55454
    United States

    Site Not Available

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

    Minneapolis 5037649, Minnesota 5037779 55454
    United States

    Active - Recruiting

  • Boston Childrens Health Physicians /ID# 258061

    Valhalla, New York 10595
    United States

    Site Not Available

  • Boston Childrens Health Physicians /ID# 258061

    Valhalla 5142090, New York 5128638 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

    Site Not Available

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

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Active - Recruiting

  • MetroHealth Medical Center /ID# 262377

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • MetroHealth Medical Center /ID# 262377

    Cleveland 5150529, Ohio 5165418 44109
    United States

    Active - Recruiting

  • Child Neurology Consultants of Austin /ID# 260562

    Austin, Texas 78757-7571
    United States

    Site Not Available

  • Child Neurology Consultants of Austin /ID# 260562

    Austin 4671654, Texas 4736286 78757-7571
    United States

    Active - Recruiting

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