ClinicaliQ Trial Snapshot
- A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG) — Recruiting • Phase II • Oncology • NCT06987539.
- What is being tested: Inebilizumab, a monoclonal antibody targeting B cells, is being evaluated for its pharmacokinetics, pharmacodynamics, safety, and tolerability in children with generalized myasthenia gravis (gMG).
- Patient eligibility overview: The trial includes pediatric participants diagnosed with gMG; specific age ranges and disease severity criteria would determine enrollment suitability.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- * 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 * Clinical syndrome consistent with a diagnosis of gMG, and not otherwise explained by another condition. * Myasthenia Gravis Foundation of America Clinical Classification Class II, III, or IV at the time of screening. * Participants must be on: * Corticosteroids only, with no dose increase within 4 weeks prior to screening, or * One allowed non-steroidal immunosuppressive therapies (IST), (azathioprine,…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.