PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
Study Identifier:
D6780C00004
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
Recruiting
Study Details
Medical Condition
- Generalized Myasthenia Gravis
- Unmapped
Study Drug
Date
Nov 2024 - Apr 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 6 - 17 Years
Requirements Information
Inclusion and Exclusion Criteria
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
Sex
Female & Male
Age
6 - 17 Years
Study Details
Medical Condition
- Generalized Myasthenia Gravis
- Unmapped
Study Drug
Date
Nov 2024 - Apr 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 6 - 17 Years years
Requirements Information
Inclusion and Exclusion Criteria
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
Protocol 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.
Trial Locations
Location
Status
Location
Research Site
Washington D.C., District of Columbia, United States, 20010
Status
Recruiting
Location
Research Site
Norfolk, Virginia, United States, 23507
Status
Recruiting
Location
Research Site
Joinville, Brazil, 89202-451
Status
Recruiting
Location
Research Site
Salvador, Brazil, 41253-190
Status
Recruiting
Location
Research Site
São José do Rio Preto, Brazil, 15090-000
Status
Recruiting
Location
Research Site
São Paulo, Brazil, 0438-002
Status
Recruiting
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