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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.
EU CTIS ID: 2022-501599-25-00
What this study is testing
The study objective is to assess efficacy, safety, and pharmacokinetics of upadacitinib with a tocilizumab reference arm in children and adolescent subjects from 1 to < 18 years old with active sJIA
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects and/or their legally authorized representative must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date an informed consent (and assent for minors as required by applicable regulation), approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. Demographic and Laboratory Assessments
- Male or female subjects, ages 1 to < 18 years old at Baseline. Note: For Cohort 1, subjects must be ages 2 to < 18 years old in countries where SC tocilizumab is not approved for sJIA.
- Subjects must have total body weight of 10 kg or higher at the time of Screening.
- Laboratory values Subjects must meet all of the following criteria within the screening period prior to the first dose of study drug: Serum aspartate transaminase (AST) and alanine aminotransferase (ALT) < 2.0 × upper limit of normal (ULN) for age and sex; Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 by modified Schwartz equation for Total white blood cell count (WBC) ≥ 3,000/iL; Absolute neutrophil count (ANC) ≥ 2,000/iL; Platelet count ≥ 100,000/iL; Absolute lymphocyte count (ALC) ≥ 750/iL; Hemoglobin ≥ 9 g/dL.
You likely can't join if
- For Cohort 1, subjects must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, subjects must have an intolerance or inadequate response to an IL-6 inhibitor as judged by the investigator.
- Subjects must not have uncontrolled severe systemic disease and/or impeding or active MAS within 1 month prior to Baseline.
- Subjects must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) and/or systemic glucocorticoids, used per local guidelines and as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Japan
- Brazil
- Mexico
- Turkey
- United Kingdom
- United States
- Argentina
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Japan; Brazil; Mexico; Turkey; United Kingdom and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.