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Clinical Trials in the USA / NCT05644561
Active, not recruiting Phase 3

Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis

NCT05644561 · tracked via the Priya Life Science USA tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 3
Started
2023-06-24
Last updated
2026-04-17

Condition(s) studied

Generalized Myasthenia GravisgMG

Investigational drug(s) / intervention(s)

Ravulizumab

Ravulizumab: Ravulizumab will be administered by intravenous (IV) infusion.

Study 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

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion 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 Exclusion Criteria: 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

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Research Site Los Angeles California
Research Site Boston Massachusetts
Research Site Chapel Hill North Carolina
Research Site Philadelphia Pennsylvania
Research Site Milan Italy
Research Site Roma Italy
Research Site Torino Italy
Research Site Itabashi-ku Japan
Research Site Belgrade Serbia
Research Site Belgrade Serbia
Research Site Bern Switzerland

On this site

📄 Ultomiris (ravulizumab) drug profile →

More Alexion Pharmaceuticals, Inc. trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05644561 on ClinicalTrials.gov ↗ ← All trials in the USA