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.
- Diseases
- Myasthenia gravis
- 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
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Trousseau Hospital Coordinator of this site? Confirm its status | Paris | France | Completed |
| The Foundation Of The Carlo Besta Neurological Institute IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Completed |
| - Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.