Who is eligible for clinical trial NCT05644561?

Participants must meet the protocol's inclusion criteria for Generalized Myasthenia Gravis. Confirm all requirements with the study coordinator.

Does clinical trial NCT05644561 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-15

Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis (NCT05644561)

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)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Alexion Pharmaceuticals, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).

Location: Research Site — Los Angeles, California

🧪 Interventions in This Study

Ravulizumab (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗