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
2 other identifiers
interventional
40
9 countries
31
Brief Summary
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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2024
Typical duration for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2023
CompletedFirst Posted
Study publicly available on registry
October 25, 2023
CompletedStudy Start
First participant enrolled
July 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
February 18, 2026
February 1, 2026
2.2 years
October 20, 2023
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
The JIA-ACR 30 response is defined as a \>= 30% improvement of at least 3 or more of the 6 juvenile idiopathic arthritis core response variables (JIA-CRVs) without \>30% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: physician global assessment of disease activity (PhGA), global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion high sensitivity C-reactive protein (hsCRP), and functional ability assessed by Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI).
Up to 24 Weeks
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Week 144
Secondary Outcomes (14)
Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50)
Up to 24 Weeks
Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70)
Up to 24 Weeks
Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90)
Up to 24 Weeks
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10
Up to Week 24
Change from Baseline in JADAS-27
Up to Week 24
- +9 more secondary outcomes
Study Arms (2)
Risankizumab
EXPERIMENTALParticipants will receive risankizumab for 24 weeks, in Period 1. 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. There will be a 140 day safety follow up after the treatment period.
Adalimumab
EXPERIMENTALParticipants will receive adalimumab for 24 weeks, in Period 1. 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. There will be a 70 day safety follow up after the treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 months prior to screening.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (31)
Arkansas Children's Hospital /ID# 258776
Little Rock, Arkansas, 72202, United States
Childrens National Medical Center /ID# 259284
Washington D.C., District of Columbia, 20010-2916, United States
Joe Dimaggio Children's Hospital Hollywood /ID# 260634
Hollywood, Florida, 33021, United States
Indiana University Health Riley Hospital for Children /ID# 259067
Indianapolis, Indiana, 46202, United States
M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
Minneapolis, Minnesota, 55454, United States
Boston Childrens Health Physicians /ID# 258061
Valhalla, New York, 10595, United States
University of North Carolina - Children's Hospital /ID# 259286
Chapel Hill, North Carolina, 27514, United States
MetroHealth Medical Center /ID# 262377
Cleveland, Ohio, 44109, United States
Child Neurology Consultants of Austin /ID# 260562
Austin, Texas, 78757-7571, United States
Monash Health - Monash Medical Centre /ID# 260255
Clayton, Victoria, 3168, Australia
Alberta Children's Hospital /ID# 257880
Calgary, Alberta, T3B 6A8, Canada
British Columbia Children and Women's Hospital and Health Centre /ID# 257884
Vancouver, British Columbia, V6H 3N1, Canada
Hospital for Sick Children /ID# 257879
Toronto, Ontario, M5G 1X8, Canada
CHU Bordeaux - Hopital Pellegrin /ID# 258729
Bordeaux, Nouvelle-Aquitaine, 33076, France
AP-HP - Hopital Bicetre /ID# 258728
Le Kremlin-Bicêtre, Paris, 94270, France
Asklepios Klinik Sankt Augustin /ID# 259106
Sankt Augustin, North Rhine-Westphalia, 53757, Germany
Helios Klinikum Berlin - Buch /ID# 268803
Berlin, 13125, Germany
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104
Hamburg, 22081, Germany
Azienda Ospedaliero Universitaria Meyer /ID# 258587
Florence, Firenze, 50139, Italy
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753
Milan, Milano, 20122, Italy
Ospedale Pediatrico Bambino Gesù /ID# 258869
Rome, Roma, 00165, Italy
Malopolskie Badania Kliniczne /ID# 258777
Krakow, Lesser Poland Voivodeship, 30-002, Poland
Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781
Lublin, Lublin Voivodeship, 20-093, Poland
Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji /ID# 277050
Warsaw, Masovian Voivodeship, 02-637, Poland
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058
Sosnowiec, Silesian Voivodeship, 41-200, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785
Lodz, Łódź Voivodeship, 91-738, Poland
Hospital Sant Joan de Deu /ID# 257568
Esplugues de Llobregat, Barcelona, 08950, Spain
Hospital Universitario y Politecnico La Fe /ID# 257567
Valencia, 46026, Spain
Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
Sheffield, England, S10 2TH, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
Bristol, BS2 8BJ, United Kingdom
Alder Hey Children's NHS Foundation Trust /ID# 262770
Liverpool, L12 2AP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2023
First Posted
October 25, 2023
Study Start
July 8, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2028
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.