Summary

Location
at UCSF
Dates
study started
completion around

Description

Summary

The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.

Official Title

A Phase 3, Open-label, Single-arm, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants (6 to < 18 Years of Age) With Generalized Myasthenia Gravis (gMG)

Keywords

Generalized Myasthenia Gravis, gMG, Myasthenia Gravis, Muscle Weakness, Ravulizumab, Ravulizumab Intravenous (IV) Infusion

Eligibility

You can join if…

  • Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period
  • Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening
  • Participants receiving treatment must be on a stable dosing regimen of adequate duration prior to Screening and during the Screening Period.
  • Eculizumab-experienced participants must have been enrolled and treated with eculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have been on a stable dose for ≥ 2 months (60 days) prior to Screening.
  • All participants must be vaccinated against meningococcal infection

You CAN'T join if...

Medical Conditions

  • Any untreated thymic malignancy, carcinoma, or thymoma.
  • Participants with a history of treated benign thymoma
  • History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening
  • History of N meningitidis infection
  • Known to be human immunodeficiency virus (HIV) positive
  • History of unexplained infections
  • Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period

Locations

  • Research Site accepting new patients
    San Francisco California 94143 United States
  • Research Site accepting new patients
    Los Angeles California 90078 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals, Inc.
ID
NCT05644561
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 12 study participants
Last Updated