SELECT-YOUTH

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

Brief 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.

Interventional study

Status:
Recruiting
Conditions:
Juvenile Idiopathic Arthritis (JIA)
Enrollment:
124 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-340
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Masking:
None (Open Label)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 2 Years to 17 Years.

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.

All the cities where the clinical studies are located

Calgary - T3B 6A8
Vancouver - V6H 3N1
Montreal - H4A 3J1

Alberta

British Columbia

Quebec