A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG) (NCT06987539)

🧪 Interventions in This Study

• Inebilizumab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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.
2. Age ≥ 2 to \< 18 years of age on the day of enrollment.
3. Diagnosis of gMG defined as:
4. 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
5. At least 1 of the following:
6. History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or
7. History of positive anticholinesterase test (eg, edrophonium chloride test); or
8. Participant demonstrated improvement in gMG signs on oral cholinesterase inhibitors, as assessed by the treating physician; or
9. Clinical syndrome consistent with a diagnosis of gMG, and not otherwise explained by another condition.
10. Myasthenia Gravis Foundation of America Clinical Classification Class II, III, or IV at the time of screening.
11. Participants must be on:
12. Corticosteroids only, with no dose increase within 4 weeks prior to screening, or

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

• Austin Neuromuscular Center — Austin, Texas
• Hopital Armand Trousseau — Paris,
• Hospital Universitari i Politecnic La Fe — Valencia,
• John Radcliffe Hospital — Headington, Oxford

📞 Contact the Study Coordinator

Phone: (866) 572-6436

Email: medinfo@amgen.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Generalized Myasthenia Gravis

• A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis — Phoenix, Arizona
• Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) — Phoenix, Arizona
• A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis — Scottsdale, Arizona
• A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis — Scottsdale, Arizona
• Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis — Orange, California

Explore by condition: All Generalized Myasthenia Gravis clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.