RecruitingGeneralized Myasthenia Gravis
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
Eligible age
2–17 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Amgen
You may qualify if…
- ✓ 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.
- ✓ Diagnosis of gMG defined as:
- ✓ 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
- ✓ At least 1 of the following:
- ✓ History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or
- ✓ History of positive anticholinesterase test (eg, edrophonium chloride test); or
- ✓ Participant demonstrated improvement in gMG signs on oral cholinesterase inhibitors, as assessed by the treating physician; or
You may not qualify if…
- ✕ 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.
- ✕ Known immunodeficiency disorder, including current infection or positive test for human immunodeficiency virus (HIV).
- ✕ Positive test for chronic hepatitis B infection at screening.
- ✕ History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV).
- ✕ History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for TB was completed per local guidelines.
Where it's recruiting
Texas
Austin
Source: ClinicalTrials.gov · NCT06987539 · last updated 2026-07-09