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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
Sponsor: AbbVie
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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.
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
Key Details
Gender
All
Age Range
5 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-07-08
Completion Date
2028-10
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
Adalimumab
SC Injection
Risankizumab
Subcutaneous (SC) Injection
Locations (31)
Arkansas Children's Hospital /ID# 258776
Little Rock, Arkansas, United States
Childrens National Medical Center /ID# 259284
Washington D.C., District of Columbia, United States
Joe Dimaggio Children's Hospital Hollywood /ID# 260634
Hollywood, Florida, United States
Indiana University Health Riley Hospital for Children /ID# 259067
Indianapolis, Indiana, United States
M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
Minneapolis, Minnesota, United States
Boston Childrens Health Physicians /ID# 258061
Valhalla, New York, United States
University of North Carolina - Children's Hospital /ID# 259286
Chapel Hill, North Carolina, United States
MetroHealth Medical Center /ID# 262377
Cleveland, Ohio, United States
Child Neurology Consultants of Austin /ID# 260562
Austin, Texas, United States
Monash Health - Monash Medical Centre /ID# 260255
Clayton, Victoria, Australia
Alberta Children's Hospital /ID# 257880
Calgary, Alberta, Canada
British Columbia Children and Women's Hospital and Health Centre /ID# 257884
Vancouver, British Columbia, Canada
Hospital for Sick Children /ID# 257879
Toronto, Ontario, Canada
CHU Bordeaux - Hopital Pellegrin /ID# 258729
Bordeaux, Nouvelle-Aquitaine, France
AP-HP - Hopital Bicetre /ID# 258728
Le Kremlin-Bicêtre, Paris, France
Asklepios Klinik Sankt Augustin /ID# 259106
Sankt Augustin, North Rhine-Westphalia, Germany
Helios Klinikum Berlin - Buch /ID# 268803
Berlin, Germany
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104
Hamburg, Germany
Azienda Ospedaliero Universitaria Meyer /ID# 258587
Florence, Firenze, Italy
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753
Milan, Milano, Italy
Ospedale Pediatrico Bambino Gesù /ID# 258869
Rome, Roma, Italy
Malopolskie Badania Kliniczne /ID# 258777
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781
Lublin, Lublin Voivodeship, Poland
Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji /ID# 277050
Warsaw, Masovian Voivodeship, Poland
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058
Sosnowiec, Silesian Voivodeship, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785
Lodz, Łódź Voivodeship, Poland
Hospital Sant Joan de Deu /ID# 257568
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario y Politecnico La Fe /ID# 257567
Valencia, Spain
Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
Sheffield, England, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
Bristol, United Kingdom
Alder Hey Children's NHS Foundation Trust /ID# 262770
Liverpool, United Kingdom