MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

Phase 2Not Yet RecruitingNCT07000292

Shanghai Changzheng Hospital12 enrolled

Overview

This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.

The primary endpoint of Phase Ib：Evaluate the safety of MSC303 in patients with Lupus Nephritis (LN）and ANCA-associated glomerulonephritis (ANCA-GN). The primary endpoint of Phase II：Evaluate the change of Urine Protein/Creatinine Ratio (UPCR) in Week 12 compared with the baseline of MSC303 in patients with Lupus Nephritis(LN） and ANCA-associated glomerulonephritis (ANCA-GN).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lupus Nephritis (LN)ANCA-Associated Glomerulonephritis

Interventions

Injection of MSC303DRUG

Dose Group 1: D1, D8, D15, and D36 were respectively given 1, 5, 15, and 15 mg of MSC303 for injection; The second dose group: D1, D8, D15 and D36 were respectively given for injection MSC303 1, 5, 20, 20 mg.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 to 65 years (including boundary values), gender unspecified； 2. Willing to participate voluntarily in this clinical study and with good compliance； 3. Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases: 1. Diagnosed with lupus nephritis(LN); 2. diagnosed with ANCA-associated glomerulonephritis (ANCA-GN); 4. Sufficient organ function; Exclusion Criteria: 1. History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303； 2. Active infection requiring antibiotic treatment； 3. Concomitant with other serious diseases； 4. Patients with congenital immunoglobulin deficiency； 5. Infection with human immunodeficiency virus (Human immunodeficiency virus (HIV)), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal Hepatitis B Virus DNA (HBV DNA) or Hepatitis C virus RNA (HCV RNA )); 6. Other exclusion criteria may apply.

Locations (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Phase Ib: safety Phase II: Urine Protein/Creatinine Ratio (UPCR)

Phase Ib: To evaluate the safety of MSC303 for injection in subjects with immune glomerular diseases. Phase II: To evaluate the change in Urine Protein/Creatinine Ratio (UPCR) from baseline at Week 12.

Time frame: 12 week

Central Contacts

Huji Xu, Ph.D, MD

CONTACT

+862181885516 xuhuji@smmu.edu.cn

Data from ClinicalTrials.gov

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