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Not Yet Recruiting NCT05644561

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

Conditions: Generalized Myasthenia Gravis, gMG

Sex: All
Ages: 6 Years – 18 Years
Phase: PHASE3
Enrollment: 12
Sponsor: Alexion Pharmaceuticals

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.

Eligibility Criteria

Inclusion Criteria:Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening PeriodMyasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at ScreeningParticipants 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 infectionExclusion Criteria:Medical ConditionsAny untreated thymic malignancy, carcinoma, or thymoma.Participants with a history of treated benign thymomaHistory of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to ScreeningHistory of N meningitidis infectionKnown to be human immunodeficiency virus (HIV) positiveHistory of unexplained infectionsKnown or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05644561). StuddyBuddy aggregates publicly available trial information.