A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis

PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

May 31, 2030

Conditions
Membranous NephropathyLupus Nephritis (LN)
Interventions
DRUG

HLX79 10mg/kg/Placebo+HLX01

Subjects with MN will receive HLX79 10mg/kg or placebo, combine with HLX01 375 mg/m2

DRUG

HLX79 20mg/kg/Placebo + HLX01

Subjects with MN will receive HLX79 20mg/kg or placebo combined with HLX01 375 mg/m2

DRUG

HLX79 30mg/kg/placebo+HLX01

Subjects with MN will receive HLX79 30mg/kg or placebo combined with HLX01 375 mg/m2

Trial Locations (17)

Unknown

NOT_YET_RECRUITING

Beijing Tsinghua Changgung Hospital, Beijing

NOT_YET_RECRUITING

Peking University People's Hospital, Beijing

NOT_YET_RECRUITING

Xiangya Hospital Of Gentral South University, Changsha

NOT_YET_RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

NOT_YET_RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

NOT_YET_RECRUITING

The First Affiliated Hospital Zhejiang University School Of Medicine, Hangzhou

NOT_YET_RECRUITING

The Second Hospital of Anhui Medical University, Hefei

NOT_YET_RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang

NOT_YET_RECRUITING

Jiangxi Provincial People's Hospital, Nanchang

NOT_YET_RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

NOT_YET_RECRUITING

Jiangsu Province Hospital, Nanjing

NOT_YET_RECRUITING

Zhongdong Hospital Southeast University, Nanjing

RECRUITING

Shanghai General Hospital, Shanghai

NOT_YET_RECRUITING

Renmin Hospital Of Wuhan University, Wuhan

NOT_YET_RECRUITING

The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an

NOT_YET_RECRUITING

The First Affiliated Hospital Of Xiamen University, Xiamen

NOT_YET_RECRUITING

Su Bei People's Hospital, Yangzhou

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY

NCT07038382 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis | Biotech Hunter | Biotech Hunter