Actively Recruiting

Phase 3
Age: 5Years - 17Years
All Genders
ID06100744

Study of Subcutaneous Risankizumab Compared to Adalimumab in Children With Active Juvenile Psoriatic Arthritis to Assess Safety, Disease Activity, and Drug Behavior

Led by AbbVie · Updated on 2026-05-13

40

Participants Needed

32

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Juvenile psoriatic arthritis (jPsA) is a type of arthritis that starts before age 16 and occurs when the immune system attacks healthy cells causing joint pain, stiffness, and swelling. This research aims to evaluate the safety of risankizumab for treating jPsA and to observe changes in disease symptoms. The study compares risankizumab with adalimumab, an approved treatment for jPsA, in a phase 3 clinical trial involving approximately 40 children worldwide. Participants are randomly assigned to receive either risankizumab or adalimumab as subcutaneous injections based on their body weight. The first period lasts 24 weeks, during which the assigned treatment is given. Those who respond to their treatment continue the same medication for an additional 100 weeks in the second period. If symptoms worsen during this time, participants may be withdrawn. After treatment ends, safety follow-up lasts 70 days for adalimumab and 140 days for risankizumab recipients. Throughout the study, participants attend regular visits at clinics or hospitals where medical assessments, blood tests, and questionnaires are used to monitor treatment effects and side effects. Researchers will measure improvement in arthritis symptoms and record any adverse events up to 144 weeks. The total study involvement can last over two years, including treatment and follow-up periods.

CONDITIONS

Official 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

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of juvenile psoriatic arthritis for at least 3 months before screening
  • Active disease in 3 or more joints at screening and baseline
  • Inadequate response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine)
Not Eligible

You will not qualify if you...

  • Presence of other autoimmune or rheumatic diseases 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

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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

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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

Frequently Asked Questions

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Study of Subcutaneous Risankizumab Compared to Adalimumab in Children With Active Juvenile Psoriatic Arthritis to Assess Safety, Disease Activity, and Drug Behavior | DecenTrialz