Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG

Study Identifier:
D7411C00003
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Eculizumab
Date
Jan 2025 - Dec 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Eculizumab
Date
Jan 2025 - Dec 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information

Protocol Summary

This is an open-label, single-arm, multi-center study to evaluate the efficacy, safety, PK, PD, and immunogenicity of eculizumab in Chinese participants with refractory gMG. Approximately 15 participants will be enrolled in the study.

Trial Locations

Location
Status
Location
Research Site
Changchun, China, 130021
Status
Not yet recruiting
Location
Research Site
Changsha, China, 410008
Status
Not yet recruiting
Location
Research Site
Fuzhou, China, 350001
Status
Not yet recruiting
Location
Research Site
Guangzhou, China, 510080
Status
Not yet recruiting
Location
Research Site
Guangzhou, China, 510620
Status
Not yet recruiting
Location
Research Site
Qingdao, China, 266035
Status
Not yet recruiting