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

July 31, 2026 updated by: AbbVie

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. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
    • North Rhine-Westphalia
      • Sankt Augustin, North Rhine-Westphalia, Germany, 53757
        • Asklepios Klinik Sankt Augustin /ID# 203264
      • Sendenhorst, North Rhine-Westphalia, 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-ken
      • Obu-shi, Aichi-ken, Japan, 474-8710
        • Aichi Children's Health and Medical Center /ID# 248327
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0045
        • Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 246582
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, 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, Miyagi, Japan, 989-3126
        • Miyagi Children's Hospital /ID# 246734
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical and Dental Hospital /ID# 247246
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Institute of Science Tokyo Hospital /ID# 246500
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406
      • San Juan, Puerto Rico, 00918-3756
        • Mindful Medical Research /ID# 204488
      • San Juan, Puerto Rico, 00917-3104
        • GCM Medical Group /ID# 211702
  • 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
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, 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, 19104
        • The 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Maximum observed plasma concentration (Cmax)
Time Frame: Day 7
Cmax is defined as the maximum observed plasma concentration for upadacitinib.
Day 7
Part 1: Time to maximum observed plasma concentration (Tmax)
Time Frame: Day 7
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)
Time Frame: Day 7
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)
Time Frame: Day 7
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Day 7
Part 1: Half-life
Time Frame: Day 7
Half life of updadacitinib will be determined using non-compartmental method.
Day 7
Treatment Emergent Adverse Events (TEAEs)
Time Frame: 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.
Up to approximately 260 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M15-340
  • 2023-505060-11-00 (Ctis)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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