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PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
Sponsor: Alexion Pharmaceuticals, Inc.
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.
Official title: An Open-Label, Single-arm Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, and Efficacy of Gefurulimab in Pediatric Patients (6 to < 18 Years of Age) With Generalized Myasthenia Gravis (gMG) Who Express Acetylcholine Receptor Antibodies (AChR+)
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2024-11-13
Completion Date
2029-01-23
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Gefurulimab
Combination product consisting of syringe prefilled with gefurulimab will be administered weekly via subcutaneous (SC) injection.
Locations (13)
Research Site
Washington D.C., District of Columbia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Joinville, Brazil
Research Site
Salvador, Brazil
Research Site
São José do Rio Preto, Brazil
Research Site
São Paulo, Brazil
Research Site
São Paulo, Brazil
Research Site
Saitama-Shi, Japan
Research Site
Bydgoszcz, Poland
Research Site
Lodz, Poland
Research Site
Warsaw, Poland
Research Site
New Taipei City, Taiwan
Research Site
Taipei, Taiwan