Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 124

Inclusion Criteria

• Individuals, ages 2 to less than 18 years, and total body weight of 10 kg or higher at the time of Screening.
• 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 arthritis affecting at least 5 joints within the first 6 months of disease (for extended oligoarticular JIA: = 4 joints within the first 6 months of disease and > 4 joints thereafter).
• 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 limitation of movement (LOM) plus pain on motion and/or tenderness with palpation, 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 • If on oral glucocorticoids, must have been taking oral glucocorticoids 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 54
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subject must not have a diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
• No prior exposure to JAK inhibitor.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the pharmacokinetics, safety, and tolerability of multiple doses of upadacitinib in pediatric subjects with pcJIA.<br>To evaluate the long-term safety and tolerability of multiple doses of upadacitinib in pediatric subjects with pcJIA who completed part 1.<br>To evaluate the long-term safety and tolerability of upadacitinib in pediatric subjects with pcJIA.<br>To evaluate descriptive efficacy of upadacitinib in pcJIA. <br><br>;Secondary Objective: To evaluate the palatability of upadacitinib oral solution in pediatric subjects.<br><br>;Primary end point(s): The values for the pharmacokinetic parameters of upadacitinib including Cmax, time to maximum observed plasma concentration (Tmax), area under the plasma concentration versus time curve during a dosing interval (AUCtau) on Day 7, and apparent oral clearance at steady state (CL/F) will be determined using non-compartmental methods.;Timepoint(s) of evaluation of this end point: Day 7

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate the palatability of upadacitinib oral solution in pediatric subjects.<br><br>;Timepoint(s) of evaluation of this end point: Day 1 and Day 7

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