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A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy
Sponsor: Bisirna Therapeutics (Suzhou) Co., Ltd.
Summary
A study of the efficacy and safety of VSA012 Injection compared to eculizumab for 24 weeks in patients with PNH.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-10-29
Completion Date
2029-12-31
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
VSA012
VSA012 Injection
Eculizumab (Soliris®)
Eculizumab injection
Locations (14)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Jilin
Jilin City, Changchun, China
Quanzhou
Quanzhou, Fujian, China
Guangzhou
Guangzhou, Guangdong, China
Nanning
Nanning, Guangxi, China
Ha'erbin
Harbin, Heilongjiang, China
Zhengzhou
Zhengzhou, Henan, China
Wuhan
Wuhan, Hubei, China
Changsha
Changsha, Hunan, China
Nantong
Nantong, Jiangsu, China
Xi'an
Xi’an, Shanxi, China
Chengdu
Chengdu, Sichuan, China
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China