Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
← catalyst calendarNCT07222553 · readout in 1,755 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 2
Status
Not yet recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
15estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-31 | estimated | When the study began enrolling |
| Primary completion | 2031-06-10 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-06-10 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Immunoglobulin G4-related Disease
Intervention
- Drug: Inebilizumab
Primary outcomes
what the primary-completion date above is the date OFMaximum Plasma Concentration (Cmax) of Inebilizumab
measured Up to Day 561
Area Under the Plasma Concentration-time Curve (AUC) of Inebilizumab
measured Up to Day 561
Clearance (CL) of Inebilizumab
measured Up to Day 561
Terminal Half-life (t½) of Inebilizumab
measured Up to Day 561
Volume of Distribution at Steady-state (Vss) of Inebilizumab
measured Up to Day 561
Change from Baseline in CD20+ B-cell Counts
measured Baseline and Day 561
Number of Participants Experiencing Adverse Events (AEs)
measured Up to Day 561
Number of Participants Experiencing Serious Adverse Events (SAEs)
measured Baseline up to Day 561
Number of Participants Experiencing Events of Interest (EOIs)
measured Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Laboratory Parameters
measured Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Vital Signs
measured Baseline up to Day 561
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