PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
Condition(s) studied
Investigational drug(s) / intervention(s)
Gefurulimab: Combination product consisting of syringe prefilled with gefurulimab will be administered weekly via subcutaneous (SC) injection.
Study summary
The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.
Eligibility
Primary outcome measure(s)
- Maximum Observed Serum Concentration (Cmax) of Gefurulimab — Day 1 predose through Week 18 predose
- Serum Free Complement Component 5 (C5) Concentration — Day 1 predose through Week 18 predose
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Washington D.C. | District of Columbia | Recruiting |
| Research Site | Norfolk | Virginia | Recruiting |
| Research Site | Joinville | Brazil | Recruiting |
| Research Site | Salvador | Brazil | Recruiting |
| Research Site | São José do Rio Preto | Brazil | Recruiting |
| Research Site | São Paulo | Brazil | Recruiting |
| Research Site | São Paulo | Brazil | Recruiting |
| Research Site | Saitama-Shi | Japan | Recruiting |
| Research Site | Bydgoszcz | Poland | Withdrawn |
| Research Site | Lodz | Poland | Withdrawn |
| Research Site | Warsaw | Poland | Recruiting |
| Research Site | New Taipei City | Taiwan | Recruiting |
| Research Site | Taipei | Taiwan | Recruiting |
More Alexion Pharmaceuticals, Inc. trials in the USA
Other trials for the same condition
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 NCT06607627 on ClinicalTrials.gov ↗ ← All trials in the USA