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Clinical Trials in Spain / NCT03725007
Active, not recruiting Phase 1

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 Spain 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
No
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)

FacilityCityRegionStatus
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

📄 Rinvoq (upadacitinib) drug profile →

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Other trials for the same condition

Tofacitinib in Juvenile Idiopathic Arthritis Starting soon
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 Spain