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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

NCT06100744 · AbbVie
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Official title
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
About this study
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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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 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.
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: single
Age groups: child
Timeline
Starts: 2024-07-08
Estimated completion: 2028-10
Last updated: 2026-02-18
Interventions
Drug: AdalimumabDrug: Risankizumab
Primary outcomes
  • Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30) (Up to 24 Weeks)
  • Number of Participants with Adverse Events (AEs) (Up to Week 144)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (31)
Arkansas Children's Hospital /ID# 258776Recruiting
Little Rock, Arkansas, United States
Childrens National Medical Center /ID# 259284Recruiting
Washington D.C., District of Columbia, United States
Joe Dimaggio Children's Hospital Hollywood /ID# 260634Recruiting
Hollywood, Florida, United States
Indiana University Health Riley Hospital for Children /ID# 259067Recruiting
Indianapolis, Indiana, United States
M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111Recruiting
Minneapolis, Minnesota, United States
Boston Childrens Health Physicians /ID# 258061Recruiting
Valhalla, New York, United States
University of North Carolina - Children's Hospital /ID# 259286Recruiting
Chapel Hill, North Carolina, United States
MetroHealth Medical Center /ID# 262377Recruiting
Cleveland, Ohio, United States
Child Neurology Consultants of Austin /ID# 260562Recruiting
Austin, Texas, United States
Monash Health - Monash Medical Centre /ID# 260255Recruiting
Clayton, Victoria, Australia
Alberta Children's Hospital /ID# 257880Recruiting
Calgary, Alberta, Canada
British Columbia Children and Women's Hospital and Health Centre /ID# 257884Recruiting
Vancouver, British Columbia, Canada
Hospital for Sick Children /ID# 257879Recruiting
Toronto, Ontario, Canada
CHU Bordeaux - Hopital Pellegrin /ID# 258729Recruiting
Bordeaux, New Aquitaine, France
AP-HP - Hopital Bicetre /ID# 258728Recruiting
Le Kremlin-Bicêtre, Paris, France
Asklepios Klinik Sankt Augustin /ID# 259106Recruiting
Sankt Augustin, North Rhine-Westphalia, Germany
Helios Klinikum Berlin - Buch /ID# 268803Recruiting
Berlin, Germany
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104Recruiting
Hamburg, Germany
Azienda Ospedaliero Universitaria Meyer /ID# 258587Recruiting
Florence, Firenze, Italy
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753Recruiting
Milan, Milano, Italy
Ospedale Pediatrico Bambino Gesù /ID# 258869Recruiting
Rome, Roma, Italy
Malopolskie Badania Kliniczne /ID# 258777Recruiting
Cracow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781Recruiting
Lublin, Lublin Voivodeship, Poland
Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji /ID# 277050Recruiting
Warsaw, Masovian Voivodeship, Poland
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058Recruiting
Sosnowiec, Silesian Voivodeship, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785Recruiting
Lodz, Łódź Voivodeship, Poland
Hospital Sant Joan de Deu /ID# 257568Recruiting
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario y Politecnico La Fe /ID# 257567Recruiting
Valencia, Spain
Sheffield Children's Hospital NHS Foundation Trust /ID# 258848Recruiting
Sheffield, England, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847Recruiting
Bristol, United Kingdom
Alder Hey Children's NHS Foundation Trust /ID# 262770Recruiting
Liverpool, United Kingdom
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 · TrialPath