Actively Recruiting
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-01
12
Participants Needed
13
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 6 to under 18 years old (12 to under 18 years old in the USA) at consent/assent signing
- Participants must have vaccination against meningococcal infection from serogroups A, C, W, Y (and B where available) within 3 years prior to intervention
- Participants vaccinated less than 2 weeks before Day 1 must receive prophylactic antibiotics for at least 2 weeks after vaccination
- Diagnosis of myasthenia gravis with generalized muscle weakness classified as MGFA Class II, III, or IV
- Positive blood test for autoantibodies against acetylcholine receptor (AChR)
You will not qualify if you...
- History of thymectomy or any thymic surgery within 12 months before screening
- Untreated thymic malignancy, carcinoma, or thymoma
- History of Neisseria meningitidis infection
- Pregnancy, breastfeeding, or intention to conceive during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Research Site
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
Research Site
Norfolk, Virginia, United States, 23507
Actively Recruiting
3
Research Site
Joinville, Brazil, 89202-451
Actively Recruiting
4
Research Site
Salvador, Brazil, 41253-190
Actively Recruiting
5
Research Site
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
6
Research Site
São Paulo, Brazil, 0438-002
Actively Recruiting
7
Research Site
São Paulo, Brazil, 05403-000
Actively Recruiting
8
Research Site
Saitama-Shi, Japan, 330-8777
Actively Recruiting
9
Research Site
Bydgoszcz, Poland, 85-065
Withdrawn
10
Research Site
Lodz, Poland, 93-338
Withdrawn
11
Research Site
Warsaw, Poland, 02-097
Actively Recruiting
12
Research Site
New Taipei City, Taiwan, 23561
Actively Recruiting
13
Research Site
Taipei, Taiwan, 11101
Actively Recruiting
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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