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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
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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.
Age
5 - 17 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 8, 2024
Primary Completion Date
September 1, 2026
Completion Date
October 1, 2028
Last Updated
February 18, 2026
40
ESTIMATED participants
Adalimumab
DRUG
Risankizumab
DRUG
Lead Sponsor
AbbVie
NCT04527380
NCT05545839
Data Source & Attribution
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