Clinical trial NCT06100744: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Juvenile Psoriatic Arthritis
Keywords: Juvenile Psoriatic Arthritis
Psoriatic Arthritis
Risankizumab
ABBV-066
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 drugs in the anti-TNF, IL-23 inhibitor, and IL-12/23 inhibitor classes.

Primary outcomes:
measure: Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
timeFrame: Up to 24 Weeks
Secondary outcomes:
measure: Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50)
timeFrame: Up to 24 Weeks
measure: Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70)
timeFrame: Up to 24 Weeks
measure: Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90)
timeFrame: Up to 24 Weeks
measure: Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10
timeFrame: Up to Week 24
measure: Change from Baseline in JADAS-27
timeFrame: Up to Week 24
measure: Percentage of Participants with Achievement of Minimal Disease Activity (MDA)
timeFrame: Week 24
measure: Percentage of Participants with Inactive Disease
timeFrame: Week 24
measure: Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10
timeFrame: Up to Week 24
measure: Change from Baseline in cJADAS-27
timeFrame: Up to Week 24
measure: Change from Baseline in the Pain-Visual Analogue Scale (VAS)
timeFrame: Week 24
measure: Percentage of Participants with Psoriasis (PsO) who Achieve Psoriasis Area Severity Index (PASI) 75 in Participants with at least 3% Body Surface Area (BSA) at Baseline
timeFrame: Up to Week 24
measure: Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline
timeFrame: Up to Week 24
measure: Percentage of Participants with PsO who Achieve Static Physician Global Assessment of Disease Activity (sPGA) of PsO of 'Clear' (0) or Almost Clear (1) in Participants with at least 3% BSA at Baseline
timeFrame: Up to Week 24
measure: Percentage of Participants with PsO who Achieve change from Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants with at least 3% BSA at Baseline
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital /ID# 258776
state: Arkansas
city: Washington
country: United States
facility: Children's National Medical Center /ID# 259284
state: District of Columbia
city: Hollywood
country: United States
facility: Joe Dimaggio Children's Hospital Hollywood /ID# 260634
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health Riley Hospital for Children /ID# 259067
state: Indiana
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111
state: Minnesota
city: Valhalla
country: United States
facility: Boston Childrens Health Physicians /ID# 258061
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Children's Hospital /ID# 259286
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center /ID# 262377
state: Ohio
city: Austin
country: United States
facility: Child Neurology Consultants of Austin /ID# 260562
state: Texas
city: Clayton
country: Australia
facility: Monash Health - Monash Medical Centre /ID# 260255
state: Victoria
city: Calgary
country: Canada
facility: Alberta Children's Hospital /ID# 257880
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Children and Women's Hospital and Health Centre /ID# 257884
state: British Columbia
city: Toronto
country: Canada
facility: Hospital for Sick Children /ID# 257879
state: Ontario
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Pellegrin /ID# 258729
state: Nouvelle-Aquitaine
city: Le Kremlin Bicetre
country: France
facility: AP-HP - Hopital Bicetre /ID# 258728
state: Paris
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin /ID# 259106
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Helios Klinikum Berlin - Buch /ID# 268803
city: Hamburg
country: Germany
facility: Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer /ID# 258587
state: Firenze
city: Lodz
country: Poland
facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785
state: Lodzkie
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781
state: Lubelskie
city: Cracow
country: Poland
facility: Malopolskie Badania Kliniczne /ID# 258777
state: Malopolskie
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu /ID# 257568
state: Barcelona
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 257567
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital NHS Foundation Trust /ID# 258848
state: England
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust /ID# 262770
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: