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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-17
SponsorAmgen

About this trial

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.

Eligibility criteria

Qualifiers

Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.

Age ≥ 2 to < 18 years of age on the day of enrollment.

Positive serologic test for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody (Ab) titers as confirmed at screening (1 retest allowed), and

History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or

Disqualifiers

Employees of the Sponsor, contract research organization (CRO), site staff, and their family members.

Thymectomy within 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the treatment period.

Unresected thymoma- Participants with benign thymoma resected > 12 months prior to screening may enroll.

History of recurrent significant infections.

Trial design

Treatments tested in this trial

  • Inebilizumab

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators