OncoMatch/Clinical Trials/NCT06987539
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
Is NCT06987539 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Inebilizumab for generalized myasthenia gravis.
Treatment: Inebilizumab — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CHRNA1 anti-acetylcholine receptor antibody positive
Positive serologic test for anti-acetylcholine receptor (AChR) antibody titers as confirmed at screening
Required: MUSK anti-muscle-specific tyrosine kinase antibody positive
Positive serologic test for anti-muscle-specific tyrosine kinase (MuSK) antibody titers as confirmed at screening
Disease stage
Required: Stage MYASTHENIA GRAVIS FOUNDATION OF AMERICA CLINICAL CLASSIFICATION CLASS II, III, IV (Myasthenia Gravis Foundation of America Clinical Classification)
Myasthenia Gravis Foundation of America Clinical Classification Class II, III, or IV at the time of screening
Prior therapy
Must have received: corticosteroid — current use
Corticosteroids only, with no dose increase within 4 weeks prior to screening
Must have received: immunosuppressive therapy (azathioprine, mycophenolate mofetil, mycophenolic acid) — current use
One allowed non-steroidal immunosuppressive therapies (IST) (azathioprine, mycophenolate mofetil, or mycophenolic acid) with continuous use for at least 6 months prior to screening and no dose increase within 4 months prior to screening
Must have received: corticosteroid + immunosuppressive therapy (azathioprine, mycophenolate mofetil, mycophenolic acid) — current use
Combination of (1) corticosteroids with no dose increase within 4 weeks prior to screening and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to screening and no dose increase within 4 months prior to screening
Cannot have received: biologic B-cell-depleting therapy (rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab)
Receipt of any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) or any experimental B-cell-depleting agent in the 6 months prior to screening
Cannot have received: monoclonal antibody or large molecule biologic
Receipt of any other monoclonal antibody (mAb) or large molecule biologic, including but not limited to FcRn inhibitors, anti-TNF mAbs, anti-janus kinase (JAK) Stat mAbs, and complement inhibitors within 6 months prior to screening
Cannot have received: other immunomodulatory therapy (alemtuzumab, natalizumab)
Receipt of the following medications or treatments at any time prior to randomization: alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, natalizumab
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Austin Neuromuscular Center · Austin, Texas
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