A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
← catalyst calendarNCT06987539 · readout in 1,302 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
15estimated
Sites
4
Countries
France, Spain, United Kingdom +1
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 | 2026-07-21 | actual | When the study began enrolling |
| Primary completion | 2030-03-13 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-03-13 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Generalized Myasthenia Gravis
Intervention
- Drug: Inebilizumab
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Concentration (Cmax) of Inebilizumab
measured Up to Week 52
Area Under the Concentration-time Curve (AUC) of Inebilizumab
measured Up to Week 52
Half-life (t1/2) of Inebilizumab
measured Up to Week 52
Clearance (CL) of Inebilizumab
measured Up to Week 52
Volume of Distribution at Steady State (Vss) of Inebilizumab
measured Up to Week 52
Change from Baseline in Cluster of Differentiation 20 (CD20)+ B-cell Counts
measured Baseline and Week 78
Number of Participants Experiencing Treatment-emergent Adverse Events
measured Up to Week 78
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
measured Up to Week 78
Number of Participants Experiencing Clinically Significant Changes in Vital Signs
measured Up to Week 78
Permalink · AMGN's whole pipeline · Catalyst calendar · Every registered study · What changed