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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Биопрепарат SCTC21C
  Drug: SCTC21C Administered SC

Первичные конечные точки

• Phase 1: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs). [Срок оценки: 36 Weeks]
• Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) at Week 24 compared to baseline [Срок оценки: 24 Weeks]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• 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;
• Known allergy to the active ingredient or excipients of the investigational drug.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 20 центров

• The First Affiliated Hospital of Baotou Medical College — Baotou
• Beijing Tsinghua Changgung Hospital — Пекин
• Peking University First Hospital — Пекин
• Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital — Чэнду
• Guangdong Provincial People's Hospital — Гуанчжоу
• The First Affliated Hospital, Zhejiang University School of Medicine — Ханчжоу
• Zhejiang Provincial People's Hospital — Ханчжоу
• Shandong Provincial Hospital — Цзинань
• … и ещё 12 центров

Идентификаторы

NCT: NCT06774664 · SCTC21C-X201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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