A Clinical Study of SCTC21C in Participants With Plasma Cell-driven Autoimmune Diseases

Launched by SINOCELLTECH LTD. · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SCTC21C to see how safe and effective it is for people with IgA nephropathy, a kidney condition caused by an issue with the immune system. The trial aims to learn more about how the drug works in the body and how well it can help manage this disease. It is not yet recruiting participants, but when it starts, it will include adults aged 18 and older who have been diagnosed with IgA nephropathy through a kidney biopsy and have been on a stable dose of certain blood pressure medications for at least 12 weeks.

To qualify for the trial, participants must meet specific criteria, such as having a certain level of kidney function and protein in their urine. They will need to understand the study procedures and agree to use reliable birth control during the study. Participants can expect close monitoring throughout the trial to ensure their safety and to gather information on how well the medication works. It's important to note that certain health conditions or recent treatments may exclude individuals from participating, so it's essential to discuss eligibility with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years at the time of signing the ICF;
• • 2. The subject has been diagnosed with IgA nephropathy through kidney tissue biopsy;
• • 3. The subject has been on a stable and maximally tolerated dose of ACEI or ARB (or the maximum allowable dose according to the prescribing information) for at least 12 weeks prior to the first dose. Subjects using both ACEI and ARB simultaneously will not be accepted;
• • 4. The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula must be ≥30 mL/min/1.73 m²;
• • 5. During the screening period, the subject must have 24-hour proteinuria ≥1.0 g or a urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g based on 24-hour urine protein;
• • 6. All male subjects or women of childbearing potential (with a negative blood pregnancy test within 7 days prior to the first dose of investigational drug) must agree to use reliable contraception together with their partner from the time of signing the ICF until 5 months after the last dose of the study drug;
• • 7. Understand the study procedures and voluntarily sign the informed consent form in writing.
• Exclusion Criteria:
• • 1. IgA nephropathy secondary to other diseases;
• • 2. Any kidney disease with special pathological or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis, etc.;
• • 3. Use of systemic corticosteroids within the 3 months prior to baseline or expected use during the study period;
• • 4. Use of systemic immunosuppressive drugs within the 3 months prior to baseline or expected use during the study period;
• • 5. Use of other B-cell-targeting biologics or unapproved investigational biologics within the 6 months prior to baseline;
• • 6. Patients who have experienced any of the following cardiovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmias, heart failure with NYHA class II or higher, stroke, etc.;
• • 7. A history of solid organ or hematopoietic stem cell or bone marrow transplantation, or expected to undergo a transplant procedure during the treatment period with the investigational drug；
• • 8. Currently undergoing hemodialysis or peritoneal dialysis, or expected to require hemodialysis or peritoneal dialysis during the treatment period with the investigational drug;
• • 9. Any symptoms or signs within 30 days prior to baseline indicating an active infection (excluding the common cold), or requiring systemic anti-infective treatment, or being at high risk for infection;
• • 10. Positive viral serology, including HIV, HCV, and HBV, etc.; Hepatitis B patients: active hepatitis or severe liver disease;
• • 11. Currently or within the past 5 years has had malignant tumors, except for fully treated skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, or cervical intraepithelial neoplasia;
• • 12. Known allergy to the active ingredient or excipients of the investigational drug.