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

AbbVie

Status and phase: Active, not recruiting; Phase 1

Conditions: Juvenile Idiopathic Arthritis (JIA)

Treatments: Drug: Upadacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03725007

M15-340

2018-000715-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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122 participants in 5 patient groups

Participants of age group 12 to <18 years receiving dose A

Experimental group

Description:

Participants of age group 12 to \<18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.

Treatment:

Drug: Upadacitinib

Participants of age group 12 to <18 years receiving dose B

Experimental group

Description:

Participants of age group 12 to \<18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.

Treatment:

Drug: Upadacitinib

Participants of age group 6 to <12 years receiving dose A

Experimental group

Description:

Participants of age group 6 to \<12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.

Treatment:

Drug: Upadacitinib

Participants of age group 2 to <6 years receiving dose A

Experimental group

Description:

Participants of age group 2 to \<6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.

Treatment:

Drug: Upadacitinib

Participants of age group 2 to <18 years receiving dose A

Experimental group

Description:

Participants of age group 2 to \<18 years administered with upadacitinib dose A as described in the protocol.

Treatment:

Drug: Upadacitinib