Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Immunoglobulin G4-related Disease (IgG4-RD)

Amgen

Summary

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.

Eligibility

Age range: 2–18 years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: 1. Participants must weigh ≥ 17 kg to be eligible for enrollment. 2. 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. 3. Age 2 to \< 18 years at the time of screening. For participants who reach the age of…

Locations (14)

University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania
Centro Oncologia Leonardo Da Vinci
Fortaleza, Ceará
Peking Union Medical College Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan

Summary

Eligibility

Interventions

Locations (14)