Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)

Description

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

Conditions

Generalized Myasthenia Gravis, gMG

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Study Overview

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Study Details

Study overview

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

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)

Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)

Condition
Generalized Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Research Site, Los Angeles, California, United States, 90078

San Francisco

Research Site, San Francisco, California, United States, 94143

Chicago

Research Site, Chicago, Illinois, United States, 60611

Boston

Research Site, Boston, Massachusetts, United States, 02115

Chapel Hill

Research Site, Chapel Hill, North Carolina, United States, 27514

Akron

Research Site, Akron, Ohio, United States, 44308

Philadelphia

Research Site, Philadelphia, Pennsylvania, United States, 19104

Denton

Research Site, Denton, Texas, United States, 76208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alexion Pharmaceuticals, Inc.,

Study Record Dates

2028-07-31