A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
argenx
Study ID
NCT06392386
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to \<18 years. The primary goal is to confirm an appropriate dose of efgartigimod PH20 SC for pediatric patients using PK and PD results from this study. Participants will receive injections of efgartigimod PH20 SC and will be monitored for safety until the end of the study. At the end of the follow-up period, eligible participants may roll over to an open-label extension (OLE) study. The participants will be in the study for up to 14 weeks.

Key Dates

Start date
Jun 28, 2024
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: Efgartigimod PH20 SC
    Participants aged 12 to \<18 years receiving efgartigimod PH20 SC treatment

Primary Outcome Measure

Efgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of Clearance (CL) [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Carolinas HealthCare System Neurosciences Institute - NeurologyCharlotteNorth Carolina28207
Urvi Desai, MD
[email protected]
857-350-4834
Neurology Rare Disease CenterDentonTexas76208
Diana Castro, MD
[email protected]
857-350-4834
University of VirginiaCharlottesvilleVirginia22903
Anna Jesus, MD
[email protected]
857-350-4834

Find similar trials in Charlotte, NC

By research site
Carolinas HealthCare System Neurosciences Institute - Neurology· Charlotte, NCNeurology Rare Disease Center· Denton, TXUniversity of Virginia· Charlottesville, VA

Related Studies