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NCT06100744 | RECRUITING | Juvenile Psoriatic Arthritis


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
Sponsor:

AbbVie

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 Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study.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

Condition or disease

Juvenile Psoriatic Arthritis

Intervention/treatment

Adalimumab

Risankizumab

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : SINGLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-07-08
Estimated Primary Completion Date : 2026-09-13
Estimated Study Completion Date : 2028-10-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 5 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT06100744


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Arkansas

Arkansas Children's Hospital /ID# 258776

Little Rock, arkansas, United States, 72202

RECRUITING

United States, Florida

Joe Dimaggio Children's Hospital Hollywood /ID# 260634

Hollywood, Florida, United States, 33021

RECRUITING

United States, Indiana

Indiana University Health Riley Hospital for Children /ID# 259067

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Minnesota

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

Minneapolis, Minnesota, United States, 55454

RECRUITING

United States, New York

Boston Childrens Health Physicians /ID# 258061

Valhalla, New York, United States, 10595

RECRUITING

United States, North Carolina

UNC Children's Hospital /ID# 259286

Chapel Hill, North Carolina, United States, 27514

RECRUITING

United States, Ohio

MetroHealth Medical Center /ID# 262377

Cleveland, Ohio, United States, 44109

RECRUITING

United States, Texas

Child Neurology Consultants of Austin /ID# 260562

Austin, Texas, United States, 78757-7571

RECRUITING

Australia, Victoria

Monash Medical Centre /ID# 260255

Clayton, Victoria, Australia, 3168

RECRUITING

Canada, Alberta

Alberta Children's Hospital /ID# 257880

Calgary, Alberta, Canada, Knock tired

RECRUITING

France, New Aquitaine

CHU Bordeaux - Hopital Pellegrin /ID# 258729

Bordeaux, New Aquitaine, France, 33076

RECRUITING

France, Paris

AP-HP - Hopital Bicetre /ID# 258728

The Kremlin Bicetre, Paris, France, 94270

RECRUITING

Germany, Saarland

Asklepios Clinic Sankt Augustin /ID# 259106

Saint Augustine, Saarland, Germany, 53757

RECRUITING

Germany,

Hamburg Center for Child and Adolescent Rheumatology /ID# 259104

Hamburg, Germany, 22081

RECRUITING

Italy, Firenze

Meyer University Hospital /ID# 258587

Florence, Firenze, Italy, 50139

RECRUITING

Poland, Lodzkie

SPZOZ Central Clinical Hospital of the Medical University of Lodz /ID# 258785

Lodz, Lodzkie, Poland, 91-738

RECRUITING

Poland, Lesser Poland

Malopolska Clinical Trials /ID# 258777

Cracow, Lesser Poland, Poland, 30-002

RECRUITING

Spain, Barcelona

Sant Joan de Deu Hospital /ID# 257568

Splugues de Llobregat, Barcelona, Spain, 08950

RECRUITING

Spain,

La Fe University and Polytechnic Hospital /ID# 257567

Valencia, Spain, 46026

RECRUITING

United Kingdom, Bristol, City Of

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

Bristol, Bristol, City Of, United Kingdom, BS2 8BJ

RECRUITING

United Kingdom, England

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

Sheffield, England, United Kingdom, S10 2TH

RECRUITING

United Kingdom,

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

Liverpool, United Kingdom, L14 5AB

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