Actively Recruiting
Open-label, Randomized, Assessor-blinded Study of Subcutaneous Risankizumab Versus Adalimumab in Children With Active Juvenile Psoriatic Arthritis
Led by AbbVie · Updated on 2026-05-13
40
Participants Needed
32
Research Sites
108 weeks
Total Duration
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AI-Summary
What this Trial Is About
Juvenile Psoriatic Arthritis (jPsA) is a type of arthritis affecting children under 16, caused by the immune system attacking healthy cells, leading to joint pain, stiffness, and swelling. Symptoms can fluctuate over time. This trial evaluates the safety of risankizumab and its effect on disease symptoms in children with active jPsA, comparing it to adalimumab, a treatment already approved for this condition. Participants are randomly assigned to receive either risankizumab or adalimumab as subcutaneous injections based on body weight. The study has two periods: Period 1 lasts 24 weeks where participants receive the assigned treatment. Those who respond continue the same treatment in Period 2 for an additional 100 weeks. Adalimumab recipients have a 70-day safety follow-up after treatment, while risankizumab recipients have a 140-day safety follow-up. Participants with worsening symptoms during Period 2 may be withdrawn. Throughout the study, participants attend regular visits at clinics or hospitals for medical assessments including blood tests, side effect monitoring, and questionnaires to evaluate disease activity and safety. The main outcomes measured include improvement in arthritis symptoms using the Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria and monitoring adverse events throughout the study lasting up to about 144 weeks.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of juvenile psoriatic arthritis (jPsA) for at least 3 months before screening
- Active disease affecting 3 or more joints with swelling or pain at screening and baseline
- Inadequate response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine
- Age between 5 and 17 years
You will not qualify if you...
- Presence of other autoimmune or rheumatic diseases, including various types of juvenile idiopathic arthritis or overlap syndromes
- Previous inadequate response to anti-TNF or IL-23 inhibitor treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 124 weeks
Participants receive subcutaneous injections of either risankizumab or adalimumab to treat juvenile psoriatic arthritis.
Visits occur throughout 24 weeks in Period 1; responders continue treatment up to 100 additional weeks in Period 2
Duration - Up to 140 days for risankizumab group; up to 70 days for adalimumab group
Participants are monitored for safety after completing treatment.
Follow-up visits occur after treatment ends
Trial Site Locations
Total: 32 locations
1
Arkansas Children's Hospital /ID# 258776
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
Childrens National Medical Center /ID# 259284
Washington D.C., District of Columbia, United States, 20010-2916
Actively Recruiting
3
Joe Dimaggio Children's Hospital Hollywood /ID# 260634
Hollywood, Florida, United States, 33021
Actively Recruiting
4
Indiana University Health Riley Hospital for Children /ID# 259067
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
6
Columbia University Medical Center /ID# 262587
New York, New York, United States, 10032-3729
Actively Recruiting
7
Boston Childrens Health Physicians /ID# 258061
Valhalla, New York, United States, 10595
Actively Recruiting
8
University of North Carolina - Children's Hospital /ID# 259286
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
9
MetroHealth Medical Center /ID# 262377
Cleveland, Ohio, United States, 44109
Actively Recruiting
10
Child Neurology Consultants of Austin /ID# 260562
Austin, Texas, United States, 78757-7571
Actively Recruiting
11
Monash Health - Monash Medical Centre /ID# 260255
Clayton, Victoria, Australia, 3168
Actively Recruiting
12
Alberta Children's Hospital /ID# 257880
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
13
British Columbia Children and Women's Hospital and Health Centre /ID# 257884
Vancouver, British Columbia, Canada, V6H 3N1
Actively Recruiting
14
Hospital for Sick Children /ID# 257879
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
15
CHU Bordeaux - Hopital Pellegrin /ID# 258729
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
16
AP-HP - Hopital Bicetre /ID# 258728
Le Kremlin-Bicêtre, Paris, France, 94270
Actively Recruiting
17
Asklepios Klinik Sankt Augustin /ID# 259106
Sankt Augustin, North Rhine-Westphalia, Germany, 53757
Actively Recruiting
18
Helios Klinikum Berlin - Buch /ID# 268803
Berlin, Germany, 13125
Actively Recruiting
19
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104
Hamburg, Germany, 22081
Actively Recruiting
20
Azienda Ospedaliero Universitaria Meyer /ID# 258587
Florence, Firenze, Italy, 50139
Actively Recruiting
21
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753
Milan, Milano, Italy, 20122
Actively Recruiting
22
Ospedale Pediatrico Bambino Gesù /ID# 258869
Rome, Roma, Italy, 00165
Actively Recruiting
23
Malopolskie Badania Kliniczne /ID# 258777
Cracow, Lesser Poland Voivodeship, Poland, 30-002
Actively Recruiting
24
Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781
Lublin, Lublin Voivodeship, Poland, 20-093
Actively Recruiting
25
Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji /ID# 277050
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
26
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058
Sosnowiec, Silesian Voivodeship, Poland, 41-200
Actively Recruiting
27
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785
Lodz, Łódź Voivodeship, Poland, 91-738
Actively Recruiting
28
Hospital Sant Joan de Deu /ID# 257568
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
29
Hospital Universitario y Politecnico La Fe /ID# 257567
Valencia, Spain, 46026
Actively Recruiting
30
Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
Sheffield, England, United Kingdom, S10 2TH
Actively Recruiting
31
University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
32
Alder Hey Children's NHS Foundation Trust /ID# 262770
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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