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Recruiting Phase 2 2025-520993-20-00

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 (gMG)

Phase 2 – studying effectiveness and dosage
Conditions: Generalized Myasthenia Gravis

Sponsor: Amgen Inc.

trial.available_in: БГ
Overview
Trial status: Authorised Change in Quantitative Myasthenia Gravis (QMG) score, Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, Presence of anti-drug antibodies (ADAs) "Pharmacokinetic parameters, including maximum observed concentration (Cmax), area under the concentration-time curve (AUC), halflife (t1/2), clearance (CL) and volume of distribution at steady state (Vss)", Change from baseline in cluster of differentiation 20 (CD20)+ B-cell counts, "Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events, adverse events of interest", Changes in laboratory parameters, Changes in vital signs
Description
Change in Quantitative Myasthenia Gravis (QMG) score, Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, Presence of anti-drug antibodies (ADAs)
Who can participate
Age group: 0-17 years Gender: Female, Male Target enrollment: 4 participants
Interventions
Uplizna 100 mg concentrate for solution for infusion
Drug
Locations 4
France (1)
Italy (1)
Poland (1)
Spain (1)
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Healthy volunteers
No
Start date
09.02.2026
Registry ID
2025-520993-20-00
Source
euclinicaltrials.eu
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