A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTC21C in Subjects With Plasma Cell-driven Autoimmune Diseases

Sinocelltech Ltd.20 sites in 1 country99 target enrollmentJanuary 2025

ConditionsIgA Nephropathy

InterventionsSCTC21C

DrugsSCTC21C

Overview

Phase: Phase 1
Intervention: SCTC21C
Conditions: IgA Nephropathy
Sponsor: Sinocelltech Ltd.
Enrollment: 99
Locations: 20
Primary Endpoint: Phase 1: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs).
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in subjects with plasma cell-driven autoimmune diseases

Detailed Description

This is a randomized, double-blind, placebo-controlled Phase I/II study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of SCTC21C in subjects with plasma cell-driven autoimmune diseases. In phase 1 study, participants will be assigned to receive sequentially higher doses of SCTC21C to determine the recommended dose of SCTC21C for the randomized dose optimization- stage. In phase 2 study, 2 dose levels will be used. A total of 72 participants will be randomized in a 1:1:1 ration to dose 1, dose 2 or placebo groups to better understand the exposure/efficacy/toxicity relationship.

Registry

clinicaltrials.gov

Start Date

January 2025

End Date

March 2029

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sinocelltech Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years at the time of signing the ICF;
•The subject has been diagnosed with IgA nephropathy through kidney tissue biopsy;
•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;
•The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula must be ≥30 mL/min/1.73 m²;
•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;
•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;
•Understand the study procedures and voluntarily sign the informed consent form in writing.

Exclusion Criteria

•IgA nephropathy secondary to other diseases;
•Any kidney disease with special pathological or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis, etc.;
•Use of systemic corticosteroids within the 3 months prior to baseline or expected use during the study period;
•Use of systemic immunosuppressive drugs within the 3 months prior to baseline or expected use during the study period;
•Use of other B-cell-targeting biologics or unapproved investigational biologics within the 6 months prior to baseline;
•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.;
•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；
•Currently undergoing hemodialysis or peritoneal dialysis, or expected to require hemodialysis or peritoneal dialysis during the treatment period with the investigational drug;
•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;
•Positive viral serology, including HIV, HCV, and HBV, etc.; Hepatitis B patients: active hepatitis or severe liver disease;

Intervention: SCTC21C

Outcomes

Primary Outcomes

Phase 1: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs).

Time Frame: 36 Weeks

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.

Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) at Week 24 compared to baseline

Time Frame: 24 Weeks

UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.

Secondary Outcomes

Phase 1: Percentage change in 24-hour urinary protein excretion compared to baseline(36 Weeks)
Phase 1: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)(36 Weeks)
Phase 1: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.(36 Weeks)
Phase 2: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)(104 Weeks)
Phase 1: C-max(24 Weeks)
Phase 1: T1/2(24 Weeks)
Phase 1: Percentage change in urine albumin-to-creatinine ratio (UACR) compared to baseline(36 Weeks)
Phase 1: Percentage change in eGFR compared to baseline(36 Weeks)
Phase 1: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline(36 Weeks)
Phase 1: AUC0-t(24 Weeks)
Phase 2: Percentage change in 24-hour urinary protein excretion compared to baseline(104 Weeks)
Phase 2: Percentage change in urine albumin-to-creatinine ratio (UACR) excretion compared to baseline(104 Weeks)
Phase 2: Percentage change in eGFR compared to baseline(104 Weeks)
Phase 2: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.(104 Weeks)
Phase 2: C-max(32 Weeks)
Phase 2: T1/2(32 Weeks)
Phase 2: AUC0-t(32 Weeks)
Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline(104 Weeks)