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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Inebilizumab will be administered via IV infusion.
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Maximum Plasma Concentration (Cmax) of Inebilizumab
Time frame: Up to Day 561
Area Under the Plasma Concentration-time Curve (AUC) of Inebilizumab
Time frame: Up to Day 561
Clearance (CL) of Inebilizumab
Time frame: Up to Day 561
Terminal Half-life (t½) of Inebilizumab
Time frame: Up to Day 561
Volume of Distribution at Steady-state (Vss) of Inebilizumab
Time frame: Up to Day 561
Change from Baseline in CD20+ B-cell Counts
Time frame: Baseline and Day 561
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to Day 561
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 561
Number of Participants Experiencing Events of Interest (EOIs)
Time frame: Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Laboratory Parameters
Time frame: Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Vital Signs
Time frame: Baseline up to Day 561
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Centro Oncologia Leonardo Da Vinci
Fortaleza, Ceará, Brazil
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Euroclinic Children Hospital
Athens, Greece
General Children Hospital Panagioti and Aglaias Kyriakou
Athens, Greece
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, Poland
Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw, Poland
...and 4 more locations
Time-to-first Treated Flare Across 52 Weeks
Time frame: Up to Week 52
Percentage of Flare-free Participants Across 52 Weeks
Time frame: Up to Week 52
Annualized Flare Rate Across 52 Weeks
Time frame: Up to Week 52
Presence of Antidrug Antibodies (ADA) Before and After Initiation of Treatment
Time frame: Day 1 to Day 561
Percent Reduction from Baseline in Daily Glucocorticoid Dose at Week 52
Time frame: Baseline and Week 52