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NCT05644561Active, not recruitingPhase 3

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

Phase 3, Open-label, Single-arm, Multicenter Study Evaluating Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants (6 to <18 Years) With Generalized Myasthenia Gravis (gMG)

Source: ClinicalTrials.gov · Last updated 17 Apr 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
12 (actual)
First submitted
1 Dec 2022
Start date
24 Jun 2023
Primary completion date
15 Jul 2026
Lead sponsor
Alexion Pharmaceuticals, Inc.
NCT number
NCT05644561
EU CT number
2022-501882-29-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 12
  • From 24 Jun 2023 to the primary completion date, 15 Jul 2026
  • 15 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening
  • Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period

Other illness

  • Medical Conditions
  • Any untreated thymic malignancy, carcinoma, or thymoma.
  • Participants with a history of treated benign thymoma
  • History of N meningitidis infection
  • Known to be human immunodeficiency virus (HIV) positive
  • History of unexplained infections

Who the study is looking for

  • 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

Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital Universitario Regional de Málaga
Coordinator of this site? Confirm its status
MálagaSpainCompleted
Assistance Publique Hôpitaux de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceCompleted
Trousseau Hospital
Coordinator of this site? Confirm its status
ParisFranceCompleted
The Foundation Of The Carlo Besta Neurological Institute IRCCS
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Bambino Gesu Childrens Hospital
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Coordinator of this site? Confirm its status
TurinItalyRecruiting
-
Coordinator of this site? Confirm its status
tabashi CityJapanUnknown status
Leiden University Medical Center
Coordinator of this site? Confirm its status
LeidenNetherlandsCompleted
-
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BelgradeSerbiaUnknown status
-
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.