PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
Recruiting now · Phase 3
Conditions studied: Generalized Myasthenia Gravis, gMG
In brief
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.
Key facts
- Study ID
- NCT06607627
- Run by
- Alexion Pharmaceuticals, Inc.
- People needed
- 12
- Starts
- 2024-11-13
- Expected to finish
- 2029-01-23
- Last updated by the study team
- 2026-04-01
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- United States of America (USA) specific inclusion criterion:
- Participant must be 12 to < 18 years of age at the time of signing the informed consent/assent.
- All participants must be vaccinated against meningococcal infection from serogroups A, B, C, W, and Y within 3 years and at least 2 weeks prior to the first dose of study intervention administration.
- Rest of World (ROW) specific inclusion criteria:
- Participant must be 6 to < 18 years of age at the time of signing the informed consent/assent.
- All participants must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) within 3 years prior to study intervention on Day 1. If vaccination occurs < 2 weeks prior to Day 1, the participants will receive prophylactic antibiotics for at least 2 weeks after initial meningococcal vaccination for serogroups A,C,W,Y (and B, where available)
- Global inclusion criteria:
- Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
- Positive serological test for autoantibodies against AChR
You may not qualify if…
- History of thymectomy, or any other thymic surgery within 12 months prior to Screening
- Untreated thymic malignancy, carcinoma, or thymoma
- History of Neisseria meningitidis infection
- Pregnancy, breastfeeding, or intention to conceive during the course of the study
Where it is running
- Research Site — Taipei, Taiwan (enrolling)
- Research Site — Norfolk, Virginia, United States (enrolling)
- Research Site — Joinville, Brazil (enrolling)
- Research Site — Salvador, Brazil (enrolling)
- Research Site — São José do Rio Preto, Brazil (enrolling)
- Research Site — São Paulo, Brazil (enrolling)
- Research Site — São Paulo, Brazil (enrolling)
- Research Site — Saitama-Shi, Japan (enrolling)
- Research Site — New Taipei City, Taiwan (enrolling)
- Research Site — Washington D.C., District of Columbia, United States (enrolling)
- Research Site — Warsaw, Poland (enrolling)
- Research Site — Bydgoszcz, Poland
- Research Site — Lodz, Poland
Full record on ClinicalTrials.gov
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