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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Have any other autoimmune conditions (where your immune system attacks your own body), 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Adalimumab

SC Injection

DRUG

Risankizumab

Subcutaneous (SC) Injection

Locations (20)

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