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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-08

Study Completion Date

2028-10-31

Brief Summary

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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

Detailed Description

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Conditions

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Juvenile Psoriatic Arthritis

Keywords

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Juvenile Psoriatic Arthritis Psoriatic Arthritis Risankizumab ABBV-066 Adalimumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous (SC) Injection

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.

Group Type EXPERIMENTAL

Adalimumab

Intervention Type DRUG

SC Injection

Interventions

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Adalimumab

SC Injection

Intervention Type DRUG

Risankizumab

Subcutaneous (SC) Injection

Intervention Type DRUG

Other Intervention Names

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ABBV-066 Skyrizi

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 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 treatments in the anti-TNF or IL-23 inhibitor classes.

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

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M23-732

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Risankizumab

Risankizumab

Adalimumab

Adalimumab

Interventions

Adalimumab

Risankizumab

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

AbbVie

Responsible Party

Principal Investigators

ABBVIE INC.

Locations

Arkansas Children's Hospital /ID# 258776

Childrens National Medical Center /ID# 259284

Joe Dimaggio Children's Hospital Hollywood /ID# 260634

Indiana University Health Riley Hospital for Children /ID# 259067

M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111

Boston Childrens Health Physicians /ID# 258061

University of North Carolina - Children's Hospital /ID# 259286

MetroHealth Medical Center /ID# 262377

Child Neurology Consultants of Austin /ID# 260562

Monash Health - Monash Medical Centre /ID# 260255

Alberta Children's Hospital /ID# 257880

British Columbia Children and Women's Hospital and Health Centre /ID# 257884

Hospital for Sick Children /ID# 257879

CHU Bordeaux - Hopital Pellegrin /ID# 258729

AP-HP - Hopital Bicetre /ID# 258728

Asklepios Klinik Sankt Augustin /ID# 259106

Helios Klinikum Berlin - Buch /ID# 268803

Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104

Azienda Ospedaliero Universitaria Meyer /ID# 258587

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753

Ospedale Pediatrico Bambino Gesù /ID# 258869

Malopolskie Badania Kliniczne /ID# 258777

Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781

Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji /ID# 277050

Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785

Hospital Sant Joan de Deu /ID# 257568

Hospital Universitario y Politecnico La Fe /ID# 257567

Sheffield Children's Hospital NHS Foundation Trust /ID# 258848

University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847

Alder Hey Children's NHS Foundation Trust /ID# 262770

Countries

Central Contacts

ABBVIE CALL CENTER

Facility Contacts

Site Coordinator

Site Coordinator

Site Coordinator

Site Coordinator

Site Coordinator

Site Coordinator

Site Coordinator

Related Links

Other Identifiers

2023-506026-36-00

M23-732