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ACTIVE NOT RECRUITING
NCT03725007
PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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

Interventions

DRUG

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