CTIS2022-501599-25-00
Recruiting
Phase 1
A multicenter, randomized open-label study to assess the efficacy, safety, and pharmacokinetics of upadacitinib with a tocilizumab reference arm in subjects from 1 year to less than 18 years old with active systemic juvenile idiopathic arthritis. - M14-682
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- juvenile idiopathic arthritis
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Enrollment
- 90
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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., Total body weight of 10 kg or higher at the time of Screening., Laboratory values meeting 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 ages \< 12 years old, and \= 60 mL/min by Cockcroft\-Gault equation for ages \= 12 years old; 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.
Exclusion Criteria
- •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 3 months prior to Baseline., Subjects must have inadequate response to previous treatment with nonsteroidal anti\-inflammatory drugs (NSAIDs) and systemic glucocorticoids, as judged by the investigator
Outcomes
Primary Outcomes
Not specified
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