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Clinical Trials in the USA / NCT06607627
Recruiting Phase 3

PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis

NCT06607627 · tracked via the Priya Life Science USA tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 3
Started
2024-11-13
Last updated
2026-04-01

Condition(s) studied

Generalized Myasthenia GravisgMG

Investigational drug(s) / intervention(s)

Gefurulimab

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

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
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

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 NCT06607627 on ClinicalTrials.gov ↗ ← All trials in the USA