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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Membranous Nephropathy, Lupus Nephritis (LN)

In brief

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.

Key facts

Study ID

NCT07038382

Run by

Shanghai Henlius Biotech

People needed

24

Starts

2025-08-05

Expected to finish

2030-05-01

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
• International normalized ratio (INR) > 2.5 (not on anticoagulant therapy).
• Interferon gamma release assay positive.
• Serological test positive for human immunodeficiency virus (HIV) antibodies.
• Test results positive for treponema pallidum (syphilis).
• Positive for hepatitis B virus (HBV) surface antigen (HBsAg), or positive for HBV core antibody (HBcAb) and HBV deoxyribonucleic acid (HBV-DNA).
• Hepatitis C virus (HCV) infection (HCV antibody positive with HCV-RNA > ULN).
• History of serious drug allergy before screening: history of allergy to two or more drugs, or history of allergy or serious side effects to HLX01, HLX79, or their excipients, or history of anaphylaxis to intravascular injection of contrast agents, human or murine proteins, or monoclonal antibodies, or history of anaphylactic shock.
• History of or need for treatment with one of the following drugs prior to screening:
• Treatment with glucocorticoids, MMF (or other forms of mycophenolate) within 1 month prior to randomization

Where it is running

• Shanghai General Hospital — Shanghai, China (enrolling)
• Peking University People's Hospital — Beijing, China
• Xiangya Hospital Of Gentral South University — Changsha, China
• Guangdong Provincial People's Hospital — Guangzhou, China
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China
• The First Affiliated Hospital Zhejiang University School Of Medicine — Hangzhou, China
• The Second Hospital of Anhui Medical University — Hefei, China
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, China
• Jiangxi Provincial People's Hospital — Nanchang, China
• The First Affiliated Hospital of Nanchang University — Nanchang, China
• Jiangsu Province Hospital — Nanjing, China
• Zhongdong Hospital Southeast University — Nanjing, China
• Renmin Hospital Of Wuhan University — Wuhan, China
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, China
• The First Affiliated Hospital Of Xiamen University — Xiamen, China
• Beijing Tsinghua Changgung Hospital — Beijing, China
• Su Bei People's Hospital — Yangzhou, China

Full record on ClinicalTrials.gov

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