AbbVie
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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.
Juvenile Psoriatic Arthritis
Adalimumab
Risankizumab
PHASE3
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 40 participants |
Masking : | SINGLE |
Primary Purpose : | TREATMENT |
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 |
Actual Study Start Date : | 2024-07-08 |
Estimated Primary Completion Date : | 2026-09-13 |
Estimated Study Completion Date : | 2028-10-07 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 5 Years to 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Arkansas Children's Hospital /ID# 258776
Little Rock, arkansas, United States, 72202
RECRUITING
Joe Dimaggio Children's Hospital Hollywood /ID# 260634
Hollywood, Florida, United States, 33021
RECRUITING
Indiana University Health Riley Hospital for Children /ID# 259067
Indianapolis, Indiana, United States, 46202
RECRUITING
M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
Minneapolis, Minnesota, United States, 55454
RECRUITING
Boston Childrens Health Physicians /ID# 258061
Valhalla, New York, United States, 10595
RECRUITING
UNC Children's Hospital /ID# 259286
Chapel Hill, North Carolina, United States, 27514
RECRUITING
MetroHealth Medical Center /ID# 262377
Cleveland, Ohio, United States, 44109
RECRUITING
Child Neurology Consultants of Austin /ID# 260562
Austin, Texas, United States, 78757-7571
RECRUITING
Monash Medical Centre /ID# 260255
Clayton, Victoria, Australia, 3168
RECRUITING
Alberta Children's Hospital /ID# 257880
Calgary, Alberta, Canada, Knock tired
RECRUITING
CHU Bordeaux - Hopital Pellegrin /ID# 258729
Bordeaux, New Aquitaine, France, 33076
RECRUITING
AP-HP - Hopital Bicetre /ID# 258728
The Kremlin Bicetre, Paris, France, 94270
RECRUITING
Asklepios Clinic Sankt Augustin /ID# 259106
Saint Augustine, Saarland, Germany, 53757
RECRUITING
Hamburg Center for Child and Adolescent Rheumatology /ID# 259104
Hamburg, Germany, 22081
RECRUITING
Meyer University Hospital /ID# 258587
Florence, Firenze, Italy, 50139
RECRUITING
SPZOZ Central Clinical Hospital of the Medical University of Lodz /ID# 258785
Lodz, Lodzkie, Poland, 91-738
RECRUITING
Malopolska Clinical Trials /ID# 258777
Cracow, Lesser Poland, Poland, 30-002
RECRUITING
Sant Joan de Deu Hospital /ID# 257568
Splugues de Llobregat, Barcelona, Spain, 08950
RECRUITING
La Fe University and Polytechnic Hospital /ID# 257567
Valencia, Spain, 46026
RECRUITING
University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
Bristol, Bristol, City Of, United Kingdom, BS2 8BJ
RECRUITING
Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
Sheffield, England, United Kingdom, S10 2TH
RECRUITING
Alder Hey Children's NHS Foundation Trust /ID# 262770
Liverpool, United Kingdom, L14 5AB