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A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
Sponsor: AbbVie
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.
Official 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
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2019-06-24
Completion Date
2027-05
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Locations (35)
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
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 /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 & Dental Hospital /ID# 247246
Niigata, Niigata, Japan
Institute of Science Tokyo Hospital /ID# 246500
Bunkyo-ku, Tokyo, Japan
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406
Bayamón, Puerto Rico
GCM Medical Group PSC /ID# 211702
San Juan, Puerto Rico
Mindful Medical Research /ID# 204488
San Juan, Puerto Rico
Hospital Sant Joan de Deu /ID# 203915
Esplugues de Llobregat, Barcelona, Spain
Hospital Infantil Universitario Nino Jesus /ID# 206466
Madrid, Spain
Hospital Universitario Ramon y Cajal /ID# 203917
Madrid, Spain
Hospital Universitario La Paz /ID# 203927
Madrid, Spain
Hospital Universitario y Politecnico La Fe /ID# 203914
Valencia, Spain
Queen Silvia Children's Hosp /ID# 251145
Gothenburg, Västra Götaland County, Sweden