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

NCT03725007 · tracked via the Priya Life Science Canada tracker

Sponsor

AbbVie

Phase

Phase 1

Started

2019-06-24

Last updated

2026-08-03

Condition(s) studied

Juvenile Idiopathic Arthritis (JIA)

Investigational drug(s) / intervention(s)

Upadacitinib →

Upadacitinib: Upadacitinib is administered as an oral solution or tablet as described in protocol.

Study 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. 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.

Eligibility

Sex

ALL

Min age

2 Years

Max age

17 Years

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.

Primary outcome measure(s)

Treatment Emergent Adverse Events (TEAEs) — Up to approximately 260 weeks
Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
Part 1: Maximum observed plasma concentration (Cmax) — Day 7
Cmax is defined as the maximum observed plasma concentration for upadacitinib.
Part 1: Time to maximum observed plasma concentration (Tmax) — Day 7
Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.
Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau) — Day 7
The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma.
Part 1: Apparent oral clearance at steady state (CL/F) — Day 7
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Part 1: Half-life — Day 7
Half life of updadacitinib will be determined using non-compartmental method.

Trial sites (35)

Facility	City	Region
Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 211162	Chicago	Illinois
Duplicate_University of Louisville /ID# 202896	Louisville	Kentucky
Boston Children's Hospital /ID# 202993	Boston	Massachusetts
Cincinnati Childrens Hospital Medical Center /ID# 209697	Cincinnati	Ohio
Randall Children's Hospital /ID# 213609	Portland	Oregon
The Children's Hospital of Philadelphia /ID# 209617	Philadelphia	Pennsylvania
Children's Hospital of Pittsburgh of UPMC /ID# 202994	Pittsburgh	Pennsylvania
Seattle Children's Hospital /ID# 203003	Seattle	Washington
Alberta Children's Hospital /ID# 251738	Calgary	Alberta
British Columbia Children and Women's Hospital and Health Centre /ID# 251736	Vancouver	British Columbia
Duplicate_McGill University Health Centre /ID# 251252	Montreal	Quebec
Asklepios Klinik Sankt Augustin /ID# 203264	Sankt Augustin	North Rhine-Westphalia
St. Josef-Stift Sendenhorst /ID# 244740	Sendenhorst	North Rhine-Westphalia
PRI - Pediatric Rheumatology Research Institute /ID# 205954	Bad Bramstedt	Schleswig-Holstein
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
Ospedale Pediatrico Bambino Gesù /ID# 203835	Rome	Roma
Aichi Children's Health and Medical Center /ID# 248327	Obu-shi	Aichi-ken
Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 246582	Kobe	Hyōgo
Kagoshima University Hospital /ID# 246501	Kagoshima	Kagoshima-ken
St Marianna University School Of Medicine /ID# 246478	Kawasaki-shi	Kanagawa
Miyagi Children's Hospital /ID# 246734	Sendai	Miyagi
Niigata University Medical and Dental Hospital /ID# 247246	Niigata	Niigata
Institute of Science Tokyo Hospital /ID# 246500	Bunkyo-ku	Tokyo
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406	Bayamón	Puerto Rico
GCM Medical Group /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
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

On this site

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Other trials for the same condition

CAPRI National Juvenile Idiopathic Arthritis Registry Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03725007 on ClinicalTrials.gov ↗ ← All trials in Canada