Inebilizumab for Immunoglobulin-Related Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for children and teens aged 2 to under 18 years who have IgG4-related disease affecting certain organs, weigh at least 17 kg, have received all required vaccines, and need treatment beyond or in addition to steroids. Consent from a parent/guardian is needed if the child is too young.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Inebilizumab
Trial Overview
The study tests how the drug inebilizumab works and how safe it is in kids with IgG4-related disease. All participants receive inebilizumab, and researchers monitor its effects on the body over time.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive Inebilizumab via intravenous (IV) infusion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
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