A Phase 2 Open-label Multicenter study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in children from 2 years to less than 18 years of age with generalized Myasthenia Gravis (gMG)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520993-20-00

Enrollment

Registered

2026-02-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Brief summary

"Pharmacokinetic parameters, including maximum observed concentration (Cmax), area under the concentration-time curve (AUC), halflife (t1/2), clearance (CL) and volume of distribution at steady state (Vss)", Change from baseline in cluster of differentiation 20 (CD20)+ B-cell counts, "Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events, adverse events of interest", Changes in laboratory parameters, Changes in vital signs

Detailed description

Change in Quantitative Myasthenia Gravis (QMG) score, Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, Presence of anti-drug antibodies (ADAs)

Interventions

DRUGUplizna 100 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
"Pharmacokinetic parameters, including maximum observed concentration (Cmax), area under the concentration-time curve (AUC), halflife (t1/2), clearance (CL) and volume of distribution at steady state (Vss)", Change from baseline in cluster of differentiation 20 (CD20)+ B-cell counts, "Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events, adverse events of interest", Changes in laboratory parameters, Changes in vital signs	—

Measure

Time frame

—

Secondary

Measure	Time frame
Change in Quantitative Myasthenia Gravis (QMG) score, Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, Presence of anti-drug antibodies (ADAs)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 12, 2026