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Not yet recruiting NCT07000292

MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

Phase I / Phase II Interventional Lupus Nephritis (LN) ANCA-Associated Glomerulonephritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Injection of MSC303.
Who it may be relevant to
Registry conditions: Lupus Nephritis (LN), ANCA-Associated Glomerulonephritis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics and Efficacy of Subcutaneous Injection of MSC303 for the Treatment of Immune Glomerular Diseases

Overview

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

Detailed description

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).

Interventions

  • Drug Injection of MSC303
    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.

Primary outcome measures

  • Phase Ib: safety Phase II: Urine Protein/Creatinine Ratio (UPCR) [Time frame: 12 week]

Eligibility criteria

Inclusion criteria

  • Aged 18 to 65 years (including boundary values), gender unspecified；
  • Willing to participate voluntarily in this clinical study and with good compliance；
  • Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:
  • Diagnosed with lupus nephritis(LN);
  • diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);
  • Sufficient organ function;

Exclusion criteria

  • History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；
  • Active infection requiring antibiotic treatment；
  • Concomitant with other serious diseases；
  • Patients with congenital immunoglobulin deficiency；
  • 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 ));
  • Other exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Changzheng Hospital — Shanghai

Identifiers

NCT: NCT07000292 · MSC303-CT201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗