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Active (not recruiting) Phase 3 NCT05644561

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

Phase 3 – large-scale trial before approval
Conditions: Generalized Myasthenia Gravis gMG

Sponsor: Alexion Pharmaceuticals, Inc.

trial.available_in: БГ
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.
Who can participate
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
Interventions
Ravulizumab
DRUG
Locations 11
Italy (3)
Research Site
Milan
Research Site
Roma
Research Site
Torino
Japan (1)
Research Site
Itabashi-ku
Serbia (2)
Research Site
Belgrade
Research Site
Belgrade
Switzerland (1)
Research Site
Bern
United States (4)
Research Site
Boston , Massachusetts
Research Site
Chapel Hill , North Carolina
Research Site
Los Angeles , California
Research Site
Philadelphia , Pennsylvania
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Healthy volunteers
No
Start date
24.06.2023
Completion date
30.06.2028
Registry ID
NCT05644561
Source
clinicaltrials.gov
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