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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: IgA Nephropathy
• Intervention / Treatment: Biological: SCTC21C

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.

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qiang Zhou; Phone Number: +86-10-58628288; Email: qiang_zhou@sinocelltech.com

Study Locations

• China
  • Baotou, China
    • The First Affiliated Hospital of Baotou Medical College
  • Beijing, China
    • Peking University First Hospital
    • Contact: Jicheng Lv
  • Beijing, China
    • Beijing Tsinghua Changgung Hospital
    • Contact: Yuehong Li
  • Chengdu, China
    • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
    • Contact: Fang Wang
  • Guangzhou, China
    • Guangdong Provincial People's Hospital
    • Contact: Zhiming Ye
  • Hangzhou, China
    • Zhejiang Provincial People's Hospital
    • Contact: Bin Zhu
  • Hangzhou, China
    • the First Affliated Hospital, Zhejiang University School of Medicine
    • Contact: Fei Han
  • Jinan, China
    • Shandong Provincial Hospital
    • Contact: Rong Wang
  • Nanchang, China
    • The First Affiliated Hospital of NanChang University
  • Nanchang, China
    • The Second Affiliated Hospital of Nanchang University
    • Contact: Gaosi Xu
  • Nanning, China
    • Guangxi Zhuang Autonomous Region People's Hospital
    • Contact: Huijuan Li
    • Contact: Lijia Xiong
  • Ningbo, China
    • Ningbo No.2 Hospital
    • Contact: Qun Luo
  • Shanghai, China
    • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    • Contact: Jingyuan Xie
  • Shanghai, China
    • Shanghai General Hospital
    • Contact: Qiuling Fan
  • Wuxi, China
    • Wuxi People's Hospital
    • Contact: Liang Wang
  • Xi'an, China
    • The First Affiliated Hospital of Xi'an Jiao Tong University
    • Contact: Jiping Sun
  • Xiamen, China
    • The first affiliated hospital of xiamen university
    • Contact: Leping Shao
  • Xingtai, China
    • The Second Affiliated Hospital of Xingtai Medical College
    • Contact: Huixiao Zheng
  • Yantai, China
    • Yantai Yuhuangding Hospital
    • Contact: Peng Li
  • Yinchuan, China
    • General Hospital of Ningxia Medical University
    • Contact: Menghua Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase I: Dose-finding: Group 1; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC
Experimental: Phase I: Dose-finding: Group 2; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC
Experimental: Phase I: Dose-finding: Group 3; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC
Experimental: Phase I: Dose-finding: Group 4; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC
Experimental: Phase 2: Group 1; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC
Experimental: Phase 2: Group 2; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC
Placebo Comparator: Phase I: Dose-finding: Group 5; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC
Placebo Comparator: Phase I: Dose-finding: Group 6; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC
Placebo Comparator: Phase 1: Dose-finding: Group 7; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC
Placebo Comparator: Phase 2: Group 3; Drug: SCTC21C Administered SC	Biological: SCTC21C; Drug: SCTC21C Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs).	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.	36 Weeks
Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) at Week 24 compared to baseline	UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline	UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.	36 Weeks
Phase 1: Percentage change in 24-hour urinary protein excretion compared to baseline		36 Weeks
Phase 1: Percentage change in urine albumin-to-creatinine ratio (UACR) compared to baseline	UACR is calculated by dividing the concentration of albumin in urine by the urine creatinine concentration.	36 Weeks
Phase 1: Percentage change in eGFR compared to baseline	eGFR is calculated using the CKD-EPI formula.	36 Weeks
Phase 1: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.		36 Weeks
Phase 1: C-max	Maximum observed plasma concentration	24 Weeks
Phase 1: T1/2	apparent terminal half-life	24 Weeks
Phase 1: AUC0-t	area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration	24 Weeks
Phase 1: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)	Results for ADA analysis were reported.	36 Weeks
Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline	UPCR is calculated by dividing the concentration of protein in urine by the urine creatinine concentration.	104 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	UPCR is calculated by dividing the concentration of albumin in urine by the urine creatinine concentration.	104 Weeks
Phase 2: Percentage change in eGFR compared to baseline	eGFR is calculated using the CKD-EPI formula.	104 Weeks
Phase 2: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.		104 Weeks
Phase 2: C-max	Maximum observed plasma concentration	32 Weeks
Phase 2: T1/2	apparent terminal half-life	32 Weeks
Phase 2: AUC0-t	area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration	32 Weeks
Phase 2: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)	Results for ADA analysis were reported.	104 Weeks

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.
• Investigators: Principal Investigator: Hong Zhang, Peking University First Hospital, Department of Nephrology

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Immune System Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: SCTC21C-X201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No