Featured Trial

Study of Oral Upadacitinib and Subcutaneous/ Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis

Study Identifier
M14-682
CT.gov Identifier
NCT05609630
EudraCT Identifier
Not available
EUCTIS ID
2022-501599-25-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
Sign up for trial alerts

Upadacitinib is being investigated for use in sJIA, an unapproved use. Safety and effectiveness have not been established.

Study Details

The SELECT sJIA research study is for children and adolescents (ages 1 to < 18) with active systemic juvenile idiopathic arthritis (sJIA). sJIA is a rare autoinflammatory disease, with symptoms like fever, rash, joint swelling, and joint pain that can affect everything from getting up in the morning to participating in school activities. Although there are approved treatments for sJIA, many patients who receive medication still experience symptoms of sJIA. Sometimes their medication becomes ineffective over time. As a result, there is a need to continue developing safe and effective treatment options for adolescents and children with sJIA.

This study is testing an experimental medicine called upadacitinib, which was designed to help block pro-inflammatory signals in the body. The study lasts 1 year, with regular check-ups and the possibility of continuing treatment if the medicine helps with symptoms. Both you and your child must agree to their participation.

Study Details

Medical Condition
  • Juvenile Idiopathic Arthritis
    • Study Drug
  • Upadacitinib
  • Tocilizumab
    • Phase
    Phase 3
    Estimated Enrollment
    90 patients

    Participating in our Juvenile Idiopathic Arthritis Clinical Trials

    If your child is eligible, they will receive either the investigational drug or a standard-of-care drug for sJIA. You, your child, and the study doctor/staff will know which study drug (investigational or standard-of-care) your child is receiving.

    Your child will receive their study drug for 52 weeks (1 year). If your child receives the investigational drug, they will take it 1 or 2 times a day by mouth. If your child receives the standard-of-care drug, they will receive an injection (a shot under the skin) every 1-2 weeks or an infusion (a needle inserted into a vein in the arm) every 2 weeks, depending on the country in which you live in.

    During the study, your child will be asked to attend approximately 12 study clinic visits for tests and assessments and will have their health closely monitored by the study doctor. Participants may or may not benefit from study participation. However, their participation could help patients with sJIA in the future.

    Study Participant Requirements

    Sex
    Female & Male
    Age
    1 Year - 17 Years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be between 1 and < 18 years old.
    • Have had symptoms of sJIA for at least 6 weeks prior to beginning the study, with onset prior to 16 years of age.
    • Have not improved enough with standard treatments like nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids.

    Participants must not:

    • Have a different type of arthritis or another autoimmune disease.
    • Have serious uncontrolled illness or a recent episode of macrophage activation syndrome (MAS).
    • Have a history of cancer, organ transplant, or serious lung disease.
    • Be pregnant, breastfeeding, or planning pregnancy during the study.

    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Baseline with a total body weight of 10 kg or higher at screening and symptoms of systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) criteria for at least 6 weeks prior to Screening, with onset prior to 16 years old, and meet the following conditions: * Must have active sJIA with at least 2 active joints at Screening and Baseline, fever more than 38°C on at least one day within 14 consecutive days before the Screening Visit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP) \> upper limit of normal (ULN) at Screening. OR At least 4 active joints at Screening and Baseline and an ESR or hsCRP \> ULN at Screening. * Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and/or systemic glucocorticoids, as judged by the investigator. * For Cohort 1, participants must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, participants must have an intolerance or inadequate response to an IL-6 inhibitor as judged by the investigator. Note: For Cohort 1, participants must be ages 2 to \< 18 years old in countries where SC tocilizumab is not approved for sJIA.
    Exclusion Criteria:
    * Has any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined by the ILAR criteria, and must not have a history or presence of any other autoimmune inflammatory condition other than sJIA. * Has uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 1 month prior to Baseline.

    Study Locations

    Location
    Status
    Location
    Phoenix Children's Hospital /ID# 253403
    Phoenix, Arizona, United States, 85016-7710
    Status
    Recruiting
    Location
    Arkansas Children'S Hospital /ID# 278405
    Little Rock, Arkansas, United States, 72202
    Status
    Not yet recruiting
    Location
    Childrens National Medical Center /ID# 253344
    Washington D.C., District of Columbia, United States, 20010-2916
    Status
    Recruiting
    Location
    Joe Dimaggio Children's Hospital Hollywood /ID# 278992
    Hollywood, Florida, United States, 33021
    Status
    Not yet recruiting
    Location
    New York Medical College /ID# 253437
    Valhalla, New York, United States, 10595
    Status
    Recruiting
    Location
    Levine Children's Hospital /ID# 253491
    Charlotte, North Carolina, United States, 28203
    Status
    Completed
    Showing {first} - {last} of {total} Results

    JAKa-US-0111-RM Version 1.0 Nov2025