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

Running, not enrolling · Phase 1

Conditions studied: Juvenile Idiopathic Arthritis (JIA)

In brief

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. Participants \<18 years of age who are ongoing in Parts 2 and 3 will participate in an 104 week open-label extension of the study in Part 4.

Key facts

Study ID

NCT03725007

Run by

AbbVie

People needed

124

Starts

2019-06-24

Expected to finish

2029-03-01

Last updated by the study team

2026-08-03

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• 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
• The 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
• Duplicate_McGill University Health Centre /ID# 251252 — Montreal, Quebec, Canada
• Asklepios Klinik Sankt Augustin /ID# 203264 — Sankt Augustin, North Rhine-Westphalia, Germany
• St. Josef-Stift Sendenhorst /ID# 244740 — Sendenhorst, North Rhine-Westphalia, Germany
• PRI - Pediatric Rheumatology Research Institute /ID# 205954 — Bad Bramstedt, Schleswig-Holstein, Germany
• Helios Klinikum Berlin-Buch /ID# 206859 — Berlin, Germany
• Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571 — Hamburg, Germany
• Semmelweis Egyetem /ID# 208970 — Budapest, Hungary
• The Chaim Sheba Medical Center /ID# 222370 — Ramat Gan, Tel Aviv, Israel
• Ospedale Pediatrico Bambino Gesù /ID# 203835 — Rome, Roma, Italy
• Aichi Children's Health and Medical Center /ID# 248327 — Obu-shi, Aichi-ken, Japan
• Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 246582 — Kobe, Hyōgo, Japan
• Kagoshima University Hospital /ID# 246501 — Kagoshima, Kagoshima-ken, Japan
• St Marianna University School Of Medicine /ID# 246478 — Kawasaki-shi, Kanagawa, Japan
• Miyagi Children's Hospital /ID# 246734 — Sendai, Miyagi, Japan
• Niigata University Medical and Dental Hospital /ID# 247246 — Niigata, Niigata, Japan

Full record on ClinicalTrials.gov

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