A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
Study Identifier
M15-340
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
For general inquiries, please contact
Recruitment Complete
Study Details
Medical Condition
Study Drug
Phase
Phase 1
Sex
Female & Male
Age
2 - 17 Years
Protocol 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.
Study Locations
Location
Status
Location
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162
Chicago, Illinois, United States, 60611
Status
Not applicable
Location
Duplicate_University of Louisville /ID# 202896
Louisville, Kentucky, United States, 40202
Status
Not applicable
Location
Boston Children's Hospital /ID# 202993
Boston, Massachusetts, United States, 02115
Status
Not applicable
Location
Cincinnati Childrens Hospital Medical Center /ID# 209697
Cincinnati, Ohio, United States, 45229
Status
Not applicable
Location
Randall Children's Hospital /ID# 213609
Portland, Oregon, United States, 97227-1654
Status
Not applicable
Location
Children's Hospital of Philadelphia /ID# 209617
Philadelphia, Pennsylvania, United States, 19146-2305
Status
Not applicable
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