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

NCT07038382 | Recruiting Phase 2 DMC

• 1 other identifier: HLX01HLX79-GN201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 17

Brief Summary

The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis. The secondary objective are to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HLX79 and HLX01, the clinical efficacy, the dynamic changes of biomarkers of HLX79 in combination with HLX01 in the treatment of glomerulonephritis. The subjects will receive different doses of HLX79 (10, 20, or 30 mg/kg) or placebo, all in combination with HLX01. After the end of the first treatment period, subjects will enter a 20-week follow-up period and then undergo pre-second treatment period assessments. If the investigator determines that the subject does not require the second treatment period, the subject will continue in follow-up until completing the total 48-week follow-up period.

Conditions

Membranous Nephropathy; Lupus Nephritis (LN)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  Including incidence, nature, and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, and the incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), abnormal laboratory tests, vital signs, physical examination, and 12-lead ECG

  24 weeks

Secondary Outcomes (18)

• Assessment of safety

  52 weeks

• Plasma concentrations and PK parameters of HLX79 and HLX01

  52 weeks

• Plasma concentrations and PK parameters of HLX79 and HLX01

  52 weeks

• Plasma concentrations and PK parameters of HLX79 and HLX01

  52 weeks

• Plasma concentrations and PK parameters of HLX79 and HLX01

  52 weeks

Study Arms (3)

Group A1

EXPERIMENTAL

Drug: HLX79 10mg/kg/Placebo+HLX01

Group B1

EXPERIMENTAL

Drug: HLX79 20mg/kg/Placebo + HLX01

Group C1

EXPERIMENTAL

Drug: HLX79 30mg/kg/placebo+HLX01

Interventions

HLX79 10mg/kg/Placebo+HLX01 DRUG

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

Group A1

HLX79 20mg/kg/Placebo + HLX01 DRUG

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

Group B1

HLX79 30mg/kg/placebo+HLX01 DRUG

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

Group C1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study procedures.
• Male or female, aged 18-75 years (both inclusive) at the time of signing the ICF.
• Diagnosed with primary membranous nephropathy (MN) within 5 year prior to screening
• If a diagnosis of primary MN is confirmed, a renal biopsy pathological diagnosis prior to screening or a renal biopsy diagnosis obtained during screening should be available, or patients with nephrotic syndrome and a positive anti-PLA2R antibody test within 6 months prior to screening; secondary MN (secondary to infection, tumor, SLE, drugs, etc.) should be excluded; subjects should have received treatment with angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin II receptor blocker (ARBs) at the highest tolerated dose judged by the investigator for 3 months prior to screening (unless intolerance to ACEI/ARB, contraindications to their use or a low blood pressure that could induce side effects, at the investigator's discretion) and also meet one of the following high-risk criteria:
• Urine protein \> 8 g/24 h at screening.(The above 3-month ACEI/ARB treatment observation period is not required)
• eGFR ≥ 60 mL/min/1.73 m2 and urine protein \> 3.5 g/24 h at screening
• Women of childbearing potential (WOCBP) must undergo a pregnancy test at screening and obtain a negative result.
• WOCBP or male subjects must agree to take effective contraceptive measures starting from signing the ICF until 12 months after the last dose of the investigational medicinal product (IMP).

You may not qualify if:

• Pregnant or lactating women, or those with a positive blood pregnancy test prior to randomization.
• WOCBP or partners of male subjects who plan to become pregnant during the study.
• History of drug or alcohol abuse within 1 year prior to screening.
• Malignancy or increased risk of malignancy prior to screening: suspected and/or diagnosed with any malignancy (except for basal cell carcinoma, squamous cell carcinoma of skin in situ, or cervical carcinoma in situ occurring within 5 years prior to screening with no evidence of recurrence after treatment).
• History of organ transplantation or stem cell or bone marrow transplantation prior to screening, or plan to undergo the above-mentioned transplantations during the study.
• Complicated with primary immunodeficiency diseases, type 1 diabetes mellitus, and type 2 diabetes mellitus (Type 2 diabetic patients with a renal biopsy report within one year prior to screening that excludes diabetic nephropathy are eligible to participate in this study) before screening.
• Presence of the following diseases that are significantly unstable or poorly controlled at screening: cardiovascular disorder, hematological disease, respiratory disorder, digestive system disorder, endocrine and metabolic system disease, nervous system disorder or psychiatric disorders, skin and subcutaneous tissue disorders, musculoskeletal system disorder, immune system disorders, or Grade 3 or greater medical abnormalities (CTCAE v5.0), and the investigator believes that the subject should be excluded due to the above diseases or abnormalities, or the investigator believes that the above diseases or abnormalities may interfere with the interpretation of the study results.
• End-stage renal disease requiring kidney transplantation or dialysis, or oliguria (urine volume \< 400 mL/24 h) at screening or prior to randomization.
• Acute, recurrent, or chronic infection (including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacterial infection) at screening,
• Infection requiring intravenous or intramuscular injection of anti-infective drugs within 2 months prior to randomization, or infection requiring hospitalization within 2 months prior to randomization.
• Lung CT or chest X-ray at screening suggesting tuberculosis infection or previous tuberculosis infection.
• Abnormalities in 12-lead ECG at screening, such as corrected QT (QTc) interval \> 450 ms in males and corrected QT (QTc) interval \> 470 ms in females (Fridericia's method).
• Abnormal results of the following laboratory tests at screening:
• Hemoglobin \< 90 g/L, or platelet count \< 100 × 109 L, or neutrophil count \< 1.5 × 109 L.
• Alkaline phosphatase (ALP) \> 2 × upper limit of normal (ULN), or total bilirubin (TB) \> 2 × ULN, or alanine aminotransferase (ALT) \> 2 × ULN, or aspartate aminotransferase (AST) \> 2 × ULN, or blood amylase \> 1.5 × ULN.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (17)

Beijing Tsinghua Changgung Hospital

Beijing, China

NOT YET RECRUITING

Peking University People's Hospital

Beijing, China

NOT YET RECRUITING

Xiangya Hospital Of Gentral South University

Changsha, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, China

NOT YET RECRUITING

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

Guangzhou, China

NOT YET RECRUITING

The First Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, China

NOT YET RECRUITING

The Second Hospital of Anhui Medical University

Hefei, China

NOT YET RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

NOT YET RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, China

NOT YET RECRUITING

Zhongdong Hospital Southeast University

Nanjing, China

NOT YET RECRUITING

Shanghai General Hospital

Shanghai, China

RECRUITING

Renmin Hospital Of Wuhan University

Wuhan, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, China

NOT YET RECRUITING

The First Affiliated Hospital Of Xiamen University

Xiamen, China

NOT YET RECRUITING

Su Bei People's Hospital

Yangzhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Qi Jin

CONTACT

+86-15955160489; qi_jin@henlius.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 26, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)