A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)

Phase 2

Not yet recruiting

• Conditions: Generalized Myasthenia Gravis
• Interventions: Drug: Inebilizumab

• Registration Number: NCT06987539
• Lead Sponsor: Amgen

Brief Summary

The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of inebilizumab administered in pediatric participants with gMG.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-08-29
• Primary Completion: 2030-01-04
• Study Completion: 2030-01-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inebilizumab	Inebilizumab	Inebilizumab will be administered intravenously (IV).

Primary Outcome Measures

Name	Time	Method
Maximum Observed Concentration (Cmax) of Inebilizumab	Up to Week 52
Area Under the Concentration-time Curve (AUC) of Inebilizumab	Up to Week 52
Half-life (t1/2) of Inebilizumab	Up to Week 52
Clearance (CL) of Inebilizumab	Up to Week 52
Volume of Distribution at Steady State (Vss) of Inebilizumab	Up to Week 52
Change from Baseline in Cluster of Differentiation 20 (CD20)+ B-cell Counts	Baseline and Week 78
Number of Participants Experiencing Treatment-emergent Adverse Events	Up to Week 78
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters	Up to Week 78
Number of Participants Experiencing Clinically Significant Changes in Vital Signs	Up to Week 78

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score	Baseline and Week 78
Change from Baseline in Euro Quality of Life-5 Dimension Youth (EQ-5D-Y) Score	Baseline and Week 78
Change from Baseline in Neurological Quality of Life (Neuro-QoL) Paediatric Fatigue Score	Baseline and Week 78
Change from Baseline in Patient Global Impression of Severity (PGI-S) Score	Baseline and Week 78
Change from Baseline in Patient Global Impression of Change (PGI-C) Score	Baseline and Week 78
Change from Baseline in Myasthenia Gravis Quality of Life-15 (MG-QOL15) Score	Baseline and Week 78
Number of Participants with Anti-drug Antibodies (ADAs) Present	Up to Week 78
Hepatitis B Vaccine Antibody (IgG) Titers	Up to Week 78
Hemophilus Influenza Type B Vaccine Antibody (IgG) Titers	Up to Week 78
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score	Baseline and Week 78