The primary purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adult participants with Acetylcholine receptor (AChR) + Generalized Myasthenia Gravis (gMG).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Participants will receive ravulizumab via intravenous (IV) infusion.
Research Site
Beijing, China
RECRUITINGResearch Site
Changchun, China
NOT_YET_RECRUITINGResearch Site
Fuzhou, China
Change From Baseline in Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Total Score at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Quantitative Myasthenia gravis (QMG) Total Score at Week 26
Time frame: Baseline, Week 26
Number of Participants With Reduction by >=5 Points From Baseline in QMG Total Score at Week 26
Time frame: Baseline up to Week 26
Number of Participants With Reduction by >=3 Points From Baseline in MG-ADL Total Score at Week 26
Time frame: Baseline up to Week 26
Change From Baseline in Revised Myasthenia Gravis Quality of Life 15-Item Scale (MG-QoL15r) Total Score at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26
Time frame: Baseline, Week 26
Serum Ravulizumab Concentration
Time frame: Day 1 up to Week 26
Change From Baseline in Serum Free C5 Concentration
Time frame: Baseline, Week 34
Number of Participants With Anti-Drug Antibodies (ADAs)
Time frame: Baseline up to Week 34
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interests (AESIs)
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Research Site
Jinan, China
NOT_YET_RECRUITINGResearch Site
Shanghai, China
RECRUITINGResearch Site
Shijiazhuang, China
RECRUITINGResearch Site
Taiyuan, China
RECRUITINGResearch Site
Tianjin, China
NOT_YET_RECRUITINGResearch Site
Wuhan, China
NOT_YET_RECRUITINGResearch Site
Zhengzhou, China
RECRUITINGTime frame: Baseline up to Week 34