The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab) + neuromyelitis optica spectrum disorder (NMOSD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Participants will receive ravulizumab via intravenous (IV) infusion.
Research Site
Beijing, China
NOT_YET_RECRUITINGResearch Site
Beijing, China
NOT_YET_RECRUITINGResearch Site
Chengdu, China
NOT_YET_RECRUITINGResearch Site
Dongguan, China
NOT_YET_RECRUITINGResearch Site
Jinan, China
NOT_YET_RECRUITINGResearch Site
Shanghai, China
RECRUITINGResearch Site
Shijiazhuang, China
NOT_YET_RECRUITINGResearch Site
Taiyuan, China
NOT_YET_RECRUITINGResearch Site
Wenzhou, China
NOT_YET_RECRUITINGResearch Site
Wuhan, China
NOT_YET_RECRUITINGAdjudicated On-Trial Annualized Relapse Rate (ARR)
Time frame: Baseline up to Week 50
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score
Time frame: Baseline up to Week 50
Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score
Time frame: Baseline up to Week 50
Change From Baseline in European Quality of Life Health 5-item Questionnaire (EQ-5D) Index Score
Time frame: Baseline, Week 50
Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score
Time frame: Baseline, Week 50
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interests (AESIs)
Time frame: Baseline up to Week 50
Serum Ravulizumab Concentration
Time frame: Day 1 to Day 351
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration
Time frame: Baseline Up to Day 351
Number of Participants With Anti-Drug Antibodies (ADAs)
Time frame: Day 1 up to Day 351
Number of Participants With Neutralizing Antibodies (NAb)
Time frame: Day 1 up to Day 351
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