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NOT YET RECRUITING
NCT07816237
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

VSA012

VSA012 Injection

DRUG

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