A Multicenter, Randomized, Open Label, Cyclosporine Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Zuberitamab Injection (HS006) in Patients With Primary Membranous Nephropathy

BioRay Pharmaceutical Co., Ltd.1 site in 1 country135 target enrollmentNovember 13, 2024

ConditionsPrimary Membranous Nephropathy

InterventionsZuberitamab 600mg Zuberitamab 1000mg cyclosporine

Overview

Phase: Phase 2
Intervention: Zuberitamab 600mg
Conditions: Primary Membranous Nephropathy
Sponsor: BioRay Pharmaceutical Co., Ltd.
Enrollment: 135
Locations: 1
Primary Endpoint: The proportion of subjects who achieved overall response (OR) in the urinary protein/creatinine ratio (UPCR) at week 76
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multicenter, randomized, open label, cyclosporine controlled Phase II trial aimed at evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of Zuberitamab in patients with primary membranous nephropathy, and exploring the Phase III dosing regimen, sample size, and endpoint evaluation time

Registry

clinicaltrials.gov

Start Date

November 13, 2024

End Date

May 10, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BioRay Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the informed consent form and be able to complete the trial according to the protocol;
•The age range is between 18 and 75 years old (including the critical value, subject to the day of signing the informed consent form), regardless of gender;
•Diagnosed with primary (idiopathic) membranous nephropathy by renal biopsy before or during screening;
•During the screening period and baseline visit, the urinary protein/creatinine ratio (UPCR) based on 24-hour urine collection should be ≥ 3.5 g/g;
•The estimated glomerular filtration rate (eGFR) using the CKD-EPI formula is ≥ 40mL/min/1.73m2;
•If you are taking angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor antagonists (ARBs), you need to maintain a stable dosage for at least 4 weeks before screening;
•Women with fertility who have a negative pregnancy test during the screening period and before the first treatment with the investigational drug (D1 \[allowed -7-day time window\]) must agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last administration; Women with fertility include all women who have had their first menstrual period and have not undergone sterilization procedures (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or have not yet reached menopause. Menopausal women are defined as having amenorrhea for at least 12 consecutive months without any other reason; Women with irregular menstrual cycles undergoing hormone replacement therapy (HRT) and serum follicle stimulating hormone (FSH) levels\>35 mIU/mL; Women who are using oral, implanted, or injectable contraceptives, or using methods such as intrauterine devices, vaginal diaphragms, condoms, and spermicides for contraception, or women who have limited sexual activity and have had their sexual partners sterilized (such as vasectomy), should be considered to have fertility.

Exclusion Criteria

•Secondary membranous nephropathy (such as malignant tumors, systemic autoimmune diseases, drugs, etc.).
•People with type 1 diabetes or type 2 diabetes with diabetic nephropathy (type 2 diabetics need to have renal biopsy reports within 1 year before screening).
•Individuals with severe allergies to rituximab or other human mouse chimeric antibodies in the past (such as anaphylactic shock and angioedema) or known allergies to any ingredients or excipients of the investigational drug.
•Individuals who have previously been resistant to cyclosporine or cyclophosphamide, or resistant to CD20 or any other therapy that leads to B cell depletion (ineffective) are identified by investigators.
•Individuals with evidence of a \>50% decrease in urine protein/creatinine ratio within the first 6 months of screening .
•There is no evidence during the screening period to suggest that the patient is positive for PMN related antibodies.
•Any of the following abnormal laboratory test results during screening: a. Abnormal liver function, defined as AST or ALT values\>2 x upper limit of normal (ULN), or total bilirubin values\>1.5 x ULN; b. Total white blood cell count\<3.0 x 109/L, absolute neutrophil count\<1.5 x 109/L, platelet count\<75 x 109/L, or hemoglobin\<90g/L.
•Virological examination results during screening: a. Hepatitis B surface antigen (HBsAg) positive individuals; b. The patient is negative for hepatitis B surface antigen and positive for hepatitis B core antibody, and the result of further hepatitis B virus DNA test exceeds the upper limit of the hospital's reference value; c. Patients with positive hepatitis C virus (HCV) antibodies and HCV RNA; d. The human immunodeficiency virus (HIV) serum reaction is positive.
•Suspected active or latent tuberculosis patients based on medical history or tuberculosis screening.
•Individuals with known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding fungal infections of the nail bed) or any major systemic infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to the baseline visit.