Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.

Detailed Description
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This study is a phase II study to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.

Official Title
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A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR1459 Tablets in the Treatment of Primary Membranous Nephropathy (PMN)

Conditions
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Primary Membranous Nephropathy

Intervention / Treatment
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* Drug: SHR1459 Low Dose
* Drug: SHR1459 High Dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of primary membranous nephropathy based on renal biopsy before or during screening Have not received any previous immunosuppressive therapy for primary membranous nephropathy or relapse after the treatment has achieved complete or partial remission (comprehensive judgment and recording by the investigator) PLA2R-Ab titer ≥20RU/mL at screening 24-hour urinary protein ≥ 3.5g/d at screening Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening Exclusion Criteria: Any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy Existence of clinically significant infection within 1 month before screening, Severe or not well controlled other complications Abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators ALT > 2 times ULN and/or AST > 2 times ULN and/or bilirubin >2 times ULN at screening Subject has evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody at screening;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SHR1459 Low Dose<br>Drug: SHR1459 SHR1459 oral 24weeks | Drug: SHR1459 Low Dose<br>* SHR1459 oral tablets taken once daily (QD) for 24weeks<br>|
| Active Comparator: SHR1459 High Dose<br>Drug: SHR0302 SHR1459 oral 24 weeks | Drug: SHR1459 High Dose<br>* SHR1459 oral tablets taken once daily (QD) for 24 weeks<br>|
| Placebo Comparator: Placebo<br>Drug: Placebo Placebo oral 24 weeks | Drug: Placebo<br>* Placebo oral tablets taken once daily (QD) for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving complete or partial remission at week 24 | Proportion of subjects achieving complete or partial remission at week 24 | 24 Weeks |