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NCT Number: NCT03725007

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Juvenile Idiopathic Arthritis (JIA) Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alberta Children's Hospital /ID# 251738, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Upadacitinib

Drug

Upadacitinib is administered as an oral solution or tablet as described in protocol.

Other names: ABT-494

Primary outcomes

  1. Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 156 weeks

    Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

  2. Part 1: Maximum observed plasma concentration (Cmax)

    Time frame: Day 7

    Cmax is defined as the maximum observed plasma concentration for upadacitinib.

  3. Part 1: Time to maximum observed plasma concentration (Tmax)

    Time frame: Day 7

    Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.

  4. Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)

    Time frame: Day 7

    The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma.

  5. Part 1: Apparent oral clearance at steady state (CL/F)

    Time frame: Day 7

    Clearance is defined as the volume of plasma cleared of the drug per unit time.

  6. Part 1: Half-life

    Time frame: Day 7

    Half life of updadacitinib will be determined using non-compartmental method.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: SELECT-YOUTH

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Oct 30, 2018
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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