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A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

NCT03725007•AbbVie

View on ClinicalTrials.gov

Summary

This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant have total body weight of 10 kg or higher at the time of screening.
•Participant diagnosed with pcJIA (rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, or systemic JIA with active arthritis and without active systemic features) with a history of arthritis affecting at least 5 joints within the first 6 months of disease (for extended oligoarticular JIA: \<=4 joints within first 6 months of disease and \>4 joints thereafter).
•Participant have 5 or more active joints at the time of screening, defined as the presence of swollen joints (not due to deformity) or, in the absence of swelling, joints with the limitation of movement (LOM) plus pain on motion and/or tenderness with palpitation, with LOM present in at least three of the active joints.
•If receiving methotrexate (MTX), have been taking MTX for at least 12 weeks immediately before and including Study Day 1 on a stable dose of \<=20 mg/m2 for at least 8 weeks before and including Study Day 1; in addition, participants should take either folic acid or folinic acid according to local standard of care.
•If on oral glucocorticosteroids, must have been taking oral glucocorticosteroids at a stable dose (no greater than 10 mg/day or 0.2 mg/kg/day, whatever is lower) for at least 1 week before and including Study Day 1.

Exclusion Criteria

•Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
•Participant have prior exposure to JAK inhibitor.

Locations (35)

Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162

Chicago, Illinois, United States

Duplicate_University of Louisville /ID# 202896

Louisville, Kentucky, United States

Boston Children's Hospital /ID# 202993

Boston, Massachusetts, United States

Cincinnati Childrens Hospital Medical Center /ID# 209697

Cincinnati, Ohio, United States

Randall Children's Hospital /ID# 213609

Portland, Oregon, United States

Children's Hospital of Philadelphia /ID# 209617

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC /ID# 202994

Pittsburgh, Pennsylvania, United States

Seattle Children's Hospital /ID# 203003

Seattle, Washington, United States

Alberta Children's Hospital /ID# 251738

Calgary, Alberta, Canada

British Columbia Children and Women's Hospital and Health Centre /ID# 251736

Vancouver, British Columbia, Canada

Key Dates

Start Date

June 24, 2019

Primary Completion Date

May 1, 2027

Completion Date

May 1, 2027

Last Updated

August 5, 2025

Enrollment

124

ESTIMATED participants

Conditions

Juvenile Idiopathic Arthritis (JIA)

Interventions

Upadacitinib

DRUG

Transcutaneous Cervical Vagus Nerve Stimulation (tcVNS) in JIA

NCT05710640

Juvenile Idiopathic Arthritis (JIA)

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COMPLETEDNA

Cognitive Exercise Therapy Approach (BETY) in JIA

NCT06591949

Childhood Rheumatic DiseasesJuvenile Idiopathic Arthritis (JIA)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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