Actively Recruiting
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
Led by Amgen · Updated on 2026-05-29
15
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effects of inebilizumab in children aged 2 to less than 18 years who have generalized myasthenia gravis (gMG). The study will focus on understanding how the drug moves through and affects the body in this pediatric population, as well as evaluating the safety and tolerability of the medication. It is a Phase 2, open-label, multicenter study sponsored by Amgen. Participants will receive inebilizumab administered intravenously (IV). The study involves monitoring the drug's concentration in the body over time, its impact on specific immune cells (CD20+ B-cells), and how the participants' symptoms and quality of life change. The treatment and observation periods last up to 78 weeks, during which various tests and assessments will be performed. Throughout the study, participants will undergo evaluations including blood tests to measure drug levels and immune cell counts, assessments of muscle strength and daily living activities, and quality of life questionnaires. Researchers will also monitor for any side effects or significant changes in vital signs and laboratory results. The total participation duration covers up to 78 weeks of follow-up to fully assess the drug's effects and safety.
CONDITIONS
Brief 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 written assent as per local guidelines.
- Age 2 to less than 18 years on the day of enrollment.
- Diagnosis of generalized myasthenia gravis confirmed by positive antibody tests and clinical criteria.
- Myasthenia Gravis Foundation of America Clinical Classification Class II, III, or IV at screening.
- Stable use of corticosteroids or one allowed non-steroidal immunosuppressive therapies for specified durations prior to screening.
- Stable dose of acetylcholinesterase inhibitors for at least 2 weeks before enrollment.
- Vital signs and laboratory tests within normal limits or deemed not clinically significant by the investigator.
You will not qualify if you...
- Employees of the sponsor, CRO, site staff, and their family members.
- Thymectomy within 12 months prior to baseline or planned thymectomy during treatment.
- Unresected thymoma; benign thymoma resected more than 12 months prior may enroll.
- History of recurrent significant infections.
- Known immunodeficiency or positive HIV test.
- Positive test for chronic hepatitis B or untreated hepatitis C infection.
- History of active or latent tuberculosis unless treated.
- History of progressive multifocal leukoencephalopathy.
- Diagnosis of congenital myasthenic syndromes.
- Receipt of biologic B-cell-depleting therapy or other specified biologics within 6 months prior to screening.
- Receipt of certain medications or treatments such as alemtuzumab or bone marrow transplant prior to randomization.
- Pregnant or breastfeeding or planning pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive intravenous administration of Inebilizumab as part of the treatment for generalized myasthenia gravis.
Visits occur during treatment up to Week 52
Duration - Up to 26 weeks after treatment (up to Week 78)
Participants are monitored for safety, tolerability, and long-term outcomes after treatment completion.
Visits occur up to Week 78 for safety and outcome assessments
Trial Site Locations
Total: 3 locations
1
Austin Neuromuscular Center
Austin, Texas, United States, 78759
Actively Recruiting
2
Hopital Armand Trousseau
Paris, France, 75012
Actively Recruiting
3
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
A
Amgen Call Center
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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