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

An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

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 Overview

• Status: Active, not recruiting
• Conditions: Juvenile Idiopathic Arthritis (JIA)
• Intervention / Treatment: Drug: Upadacitinib

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Alberta Children's Hospital /ID# 251738
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • British Columbia Children and Women's Hospital and Health Centre /ID# 251736
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Duplicate_McGill University Health Centre /ID# 251252
• Germany
  • Berlin, Germany, 13125
    • Helios Klinikum Berlin-Buch /ID# 206859
  • Hamburg, Germany, 22081
    • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571
  • Nordrhein-Westfalen
    • Sankt Augustin, Nordrhein-Westfalen, Germany, 53757
      • Asklepios Klinik Sankt Augustin /ID# 203264
    • Sendenhorst, Nordrhein-Westfalen, Germany, 48324
      • St. Josef-Stift Sendenhorst /ID# 244740
  • Schleswig-Holstein
    • Bad Bramstedt, Schleswig-Holstein, Germany, 24576
      • PRI - Pediatric Rheumatology Research Institute /ID# 205954
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 208970
• Israel
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 222370
• Italy
  • Roma
    • Rome, Roma, Italy, 00165
      • Ospedale Pediatrico Bambino Gesù /ID# 203835
• Japan
  • Aichi
    • Obu-shi, Aichi, Japan, 474-8710
      • Aichi Children's Health and Medical Center /ID# 248327
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0047
      • Hyogo Prefectural Kobe Children's Hospital /ID# 246582
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 890-8520
      • Kagoshima University Hospital /ID# 246501
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St Marianna University School Of Medicine /ID# 246478
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 989-3126
      • Miyagi Children's Hospital /ID# 246734
  • Niigata
    • Niigata-shi, Niigata, Japan, 951-8520
      • Niigata University Medical & Dental Hospital /ID# 247246
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Institute of Science Tokyo Hospital /ID# 246500
• Puerto Rico
  • Bayamon, Puerto Rico, 00959
    • Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406
  • San Juan, Puerto Rico, 00917-3104
    • GCM Medical Group PSC /ID# 211702
  • San Juan, Puerto Rico, 00918-3756
    • Mindful Medical Research /ID# 204488
• Spain
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Nino Jesus /ID# 206466
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 203917
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 203927
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 203914
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Deu /ID# 203915
• Sweden
  • Vastra Gotalands Lan
    • Gothenburg, Vastra Gotalands Lan, Sweden, 416 85
      • Queen Silvia Children's Hosp /ID# 251145
• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Duplicate_University of Louisville /ID# 202896
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital /ID# 202993
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center /ID# 209697
  • Oregon
    • Portland, Oregon, United States, 97227-1654
      • Randall Children's Hospital /ID# 213609
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146-2305
      • Children's Hospital of Philadelphia /ID# 209617
    • Pittsburgh, Pennsylvania, United States, 15224-1334
      • Children's Hospital of Pittsburgh of UPMC /ID# 202994
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital /ID# 203003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants of age group 12 to <18 years receiving dose A; Participants of age group 12 to <18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.	Drug: Upadacitinib; Upadacitinib is administered as an oral solution or tablet as described in protocol.; Other Names: ABT-494
Experimental: Participants of age group 12 to <18 years receiving dose B; Participants of age group 12 to <18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.	Drug: Upadacitinib; Upadacitinib is administered as an oral solution or tablet as described in protocol.; Other Names: ABT-494
Experimental: Participants of age group 6 to <12 years receiving dose A; Participants of age group 6 to <12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.	Drug: Upadacitinib; Upadacitinib is administered as an oral solution or tablet as described in protocol.; Other Names: ABT-494
Experimental: Participants of age group 2 to <6 years receiving dose A; Participants of age group 2 to <6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.	Drug: Upadacitinib; Upadacitinib is administered as an oral solution or tablet as described in protocol.; Other Names: ABT-494
Experimental: Participants of age group 2 to <18 years receiving dose A; Participants of age group 2 to <18 years administered with upadacitinib dose A as described in the protocol.	Drug: Upadacitinib; Upadacitinib is administered as an oral solution or tablet as described in protocol.; Other Names: ABT-494

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events (TEAEs)	Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.	Up to approximately 156 weeks
Part 1: Maximum observed plasma concentration (Cmax)	Cmax is defined as the maximum observed plasma concentration for upadacitinib.	Day 7
Part 1: Time to maximum observed plasma concentration (Tmax)	Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.	Day 7
Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)	The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma.	Day 7
Part 1: Apparent oral clearance at steady state (CL/F)	Clearance is defined as the volume of plasma cleared of the drug per unit time.	Day 7
Part 1: Half-life	Half life of updadacitinib will be determined using non-compartmental method.	Day 7

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 27, 2018
• First Submitted That Met QC Criteria: October 27, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Upadacitinib; ABT-494; Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Juvenile; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Upadacitinib
• Other Study ID Numbers: M15-340; 2018-000715-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No