RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2023-06-24
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05644561

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period
  2. * Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening
  3. * Participants receiving treatment must be on a stable dosing regimen of adequate duration prior to Screening and during the Screening Period.
  4. * 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.
  5. * All participants must be vaccinated against meningococcal infection
  1. * Any untreated thymic malignancy, carcinoma, or thymoma.
  2. * Participants with a history of treated benign thymoma
  3. * History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening
  4. * History of N meningitidis infection
  5. * Known to be human immunodeficiency virus (HIV) positive
  6. * History of unexplained infections
  7. * Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period

Contacts and Locations

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
1-855-752-2356
clinicaltrials@alexion.com

Study Locations (Sites)

Research Site
Los Angeles, California, 90078
United States
Research Site
San Francisco, California, 94143
United States
Research Site
Chicago, Illinois, 60611
United States
Research Site
Boston, Massachusetts, 02115
United States
Research Site
Chapel Hill, North Carolina, 27514
United States
Research Site
Akron, Ohio, 44308
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Denton, Texas, 76208
United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-24
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2023-06-24
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

  • Generalized Myasthenia Gravis
  • gMG

Additional Relevant MeSH Terms

  • Generalized Myasthenia Gravis
  • gMG