The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD), as well as to assess the safety and tolerability, of inebilizumab in pediatric participants with IgG4-RD.
Participants must weigh ≥ 17 kg to be eligible for enrollment.
Participant has provided informed consent/assent before initiation of any study-specific activities/procedures. Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent, and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.
Age 2 to < 18 years at the time of screening. For participants who reach the age of legal consent during the clinical study, notification will be required, and a new consent form must be signed by the participant for continuation in the study.
Clinical diagnosis of IgG4-RD.
aspartate aminotransferase (AST) > 10 × upper limit of normal (ULN)
alanine aminotransferase (ALT) > 10 × ULN
total bilirubin (TBL) > 5 × ULN Screening liver function tests may be repeated before Day 1 to permit abnormal values due to hepatobiliary IgG4-RD activity to respond to GC treatment.
platelet count < 75000/μL (or < 75 × 109/L)