Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy

Study Overview
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Brief Summary
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The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.

Official Title
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A Phase II Seamless Design, Randomized, Double-blind, Placebo-controlled, Dose-exploration Study Evaluate the Efficacy and Safety of SHR-2010 Injection in Patients With Primary IgA Nephropathy

Conditions
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Primary IgA Nephropathy

Intervention / Treatment
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* Drug: SHR-2010 Injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide a written informed consent Renal biopsy confirmed primary IgA nephropathy 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g eGFR≥30 mL/min/ 1.73m2 40kg≤ Weight ≤100kg Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose). Exclusion Criteria: systemic disease which may cause secondary IgA deposition in the mesangial region Specific type of IgA nephropathy History of severe opportunistic infection A history of chronic or recurrent infection within 1 year prior to screening History of active digestive system within one year Have a malignant tumor or a history of malignant tumor Subjects who have received organ transplants Associated with other serious or poorly controlled systemic diseases Hepatitis, syphilis, human immunodeficiency virus (HIV) infection Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period. Received any systemic glucocorticoid 8 weeks before screening or during run-in period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-2010 Injection<br> | Drug: SHR-2010 Injection<br>* SHR-2010 Injection<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks. |  | 12 weeks | 
| Part 2: change from baseline in UPCR at 24weeks. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in 24 hours urinary protein at 12 weeks (part 1) |  | 12 weeks | 
| change from baseline in 24 hours urinary protein at 24 weeks (part 2) |  | 24 weeks | 
| change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1） |  | 12 weeks | 
| change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）. |  | 24 weeks | 
| change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）. |  | 12, 24 weeks | 
| change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）. |  | 24, 36 weeks |