A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy

Study Overview
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Brief Summary
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This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

Detailed Description
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IgA nephropathy is a kidney disease in which IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. This study will seek to determine the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy. The study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. Subjects with confirmed IgA nephropathy will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).

Official Title
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A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Telitacicept 160mg
* Drug: Telitacicept 240mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IgA nephropathy confirmed by pathological biopsy; Male or female aged ≥ 18 years old; Average 24-hour urine total protein ≥ 0.75 g/24 h Estimated GFR (using the CKD-EPI formula) > 30 mL/min per 1.73 m^2; Stabilized AEI/ARB medications, diuretics, or other antihypertensive therapy. Exclusion Criteria: Patients with clinically significant abnormal laboratory tests at screening; Evidence of rapid eGFR decrease > 15 ml/min during screening; Renal or other organ transplantation prior to, or expected during, the study; Patients with secondary IgA nephropathy; Patients with nephrotic syndrome, crescentic nephritis minimal change nephropathy with IgA deposition, or other pathological or clinical types of renal diseases that may confound the study data interpretation; Patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening; Immunocompromised individuals.

Ages Eligible for Study
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Minimum Age: 18 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: Telitacicept 160mg<br>Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses | Drug: Telitacicept 160mg<br>* Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.<br>|
| Experimental: Telitacicept 240mg<br>Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses | Drug: Telitacicept 240mg<br>* Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.<br>|
| Placebo Comparator: Placebo<br>Placebo subcutaneous injection once weekly, and a total of 24 doses | Drug: Placebo<br>* Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 24-hour urine protein at Week 24. | Change from baseline in urine protein over 24 hours to Week 24 will be measured | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48 | Change from baseline in eGFR by visit | Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48 | 
| Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48; | Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit. | Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48 | 
| Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit. | Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Berger Disease, Berger's Disease, IGA Glomerulonephritis, IGA Nephropathy, Primary IGA Nephropathy, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA