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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 6 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.

Locations
United States
Arkansas
Arkansas Children's Hospital /ID# 258776
RECRUITING
Little Rock
Washington, D.c.
Children's National Medical Center /ID# 259284
RECRUITING
Washington D.c.
Florida
Joe Dimaggio Children's Hospital Hollywood /ID# 260634
RECRUITING
Hollywood
Indiana
Indiana University Health Riley Hospital for Children /ID# 259067
RECRUITING
Indianapolis
Minnesota
M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
RECRUITING
Minneapolis
North Carolina
University of North Carolina - Children's Hospital /ID# 259286
RECRUITING
Chapel Hill
New York
Boston Childrens Health Physicians /ID# 258061
RECRUITING
Valhalla
Ohio
MetroHealth Medical Center /ID# 262377
RECRUITING
Cleveland
Texas
Child Neurology Consultants of Austin /ID# 260562
RECRUITING
Austin
Other Locations
Australia
Monash Health - Monash Medical Centre /ID# 260255
RECRUITING
Clayton
Canada
Alberta Children's Hospital /ID# 257880
RECRUITING
Calgary
Hospital for Sick Children /ID# 257879
RECRUITING
Toronto
British Columbia Children and Women's Hospital and Health Centre /ID# 257884
RECRUITING
Vancouver
France
CHU Bordeaux - Hopital Pellegrin /ID# 258729
RECRUITING
Bordeaux
AP-HP - Hopital Bicetre /ID# 258728
RECRUITING
Le Kremlin-bicêtre
Germany
Helios Klinikum Berlin - Buch /ID# 268803
RECRUITING
Berlin
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104
RECRUITING
Hamburg
Asklepios Klinik Sankt Augustin /ID# 259106
RECRUITING
Sankt Augustin
Italy
Azienda Ospedaliero Universitaria Meyer /ID# 258587
RECRUITING
Florence
Ospedale Pediatrico Bambino Gesù /ID# 258869
RECRUITING
Rome
Poland
Malopolskie Badania Kliniczne /ID# 258777
RECRUITING
Krakow
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785
RECRUITING
Lodz
Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781
RECRUITING
Lublin
Spain
Hospital Sant Joan de Deu /ID# 257568
RECRUITING
Esplugues De Llobregat
Hospital Universitario y Politecnico La Fe /ID# 257567
RECRUITING
Valencia
United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
RECRUITING
Bristol
Alder Hey Children's NHS Foundation Trust /ID# 262770
RECRUITING
Liverpool
Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
RECRUITING
Sheffield
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-07-08
Estimated Completion Date: 2028-10
Participants
Target number of participants: 40
Treatments
Experimental: Risankizumab
Participants 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.
Experimental: Adalimumab
Participants 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.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov