Actively Recruiting
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
Led by Amgen · Updated on 2026-05-14
15
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant's legally authorized representative has provided informed consent and the participant has provided assent as appropriate before starting study procedures.
- Age between 2 and less than 18 years on the day of enrollment.
- Diagnosis of generalized myasthenia gravis confirmed by positive antibody tests and clinical or diagnostic criteria.
- Myasthenia Gravis Foundation of America Clinical Classification Class II, III, or IV at screening.
- Currently on corticosteroids only with no dose increase within 4 weeks prior to screening, or one allowed non-steroidal immunosuppressive therapy with continuous use for at least 6 months and no dose increase within 4 months prior to screening, or a combination of both under these conditions.
- Stable dose of acetylcholinesterase inhibitors for at least 2 weeks before enrollment.
- Vital signs and laboratory tests within normal ranges or not clinically significant if outside normal ranges at screening.
You will not qualify if you...
- Employees of the sponsor, contract research organizations, site staff, and their family members.
- Thymectomy within 12 months before baseline or planned thymectomy during the treatment period.
- Unresected thymoma; benign thymoma resected more than 12 months prior to screening may enroll.
- History of recurrent significant infections.
- Known immunodeficiency disorders or current infection including positive HIV test.
- Positive test for chronic hepatitis B infection at screening.
- History of untreated hepatitis C infection or positive hepatitis C antibody test.
- History of active or latent tuberculosis or positive TB test unless treated.
- History of progressive multifocal leukoencephalopathy.
- Diagnosis of congenital myasthenic syndromes.
- Receipt of any biologic B-cell-depleting therapy or experimental B-cell-depleting agents within 6 months prior to screening.
- Receipt of other monoclonal antibodies or large molecule biologics within 6 months prior to screening.
- Prior treatments including alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or natalizumab.
- Pregnancy, breastfeeding, or planning to become pregnant.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Austin Neuromuscular Center
Austin, Texas, United States, 78759
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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