PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorAlexion Pharmaceuticals, Inc.
About this trial
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 criteria
Qualifiers
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.
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Gefurulimab
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov