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
Condition(s) studied
Generalized Myasthenia GravisgMG
Investigational drug(s) / intervention(s)
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
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)
- Serum Concentration of Ravulizumab — Day 1 predose through Week 18 predose
- Serum Free C5 Concentration — Day 1 predose through Week 18 predose
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
Other trials for the same condition
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