Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
argenx
Study ID
NCT04833894
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod IV — BIOLOGICAL
    Intravenous infusion of Efgartigimod

Study Details

The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: * The maximum trial duration for each individual participant will be approximately 28 weeks * The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)

Key Dates

Start date
Oct 26, 2021
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: Efgartigimod
    Patients receiving efgartigimod intravenous (IV) treatment

Primary Outcome Measure

Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Clearance (CL) [ Time Frame: up to 26 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Ann and Robert H Lurie Children's Hospital of Chicago - Main HospitalChicagoIllinois60611
Nancy Kuntz, MD
[email protected]
8573504834
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
James Howard, MD
[email protected]
8573504834
University of Virginia (UVA) Health - Developmental Pediatrics ClinicCharlottesvilleVirginia22903
Anna Jesus, MD
[email protected]
857-350-4834

Find similar trials in Chicago, IL

By research site
Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital· Chicago, ILUniversity of North Carolina at Chapel Hill· Chapel Hill, NCUniversity of Virginia (UVA) Health - Developmental Pediatrics Clinic· Charlottesville, VA

Related Studies