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

Part of paid clinical trials in Austin, Texas.

Sponsor
Amgen
Study ID
NCT06987539
Phase
PHASE2
Status
Recruiting
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Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Mar 13, 2030
Completion
Mar 13, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Inebilizumab
    Inebilizumab will be administered intravenously (IV).

Primary Outcome Measure

Maximum Observed Concentration (Cmax) of Inebilizumab [ Time Frame: Up to Week 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Austin Neuromuscular CenterAustinTexas78759-

Find similar trials in Austin, TX

By research site
Austin Neuromuscular Center· Austin, TX

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