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

NCT06774664 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SCTC21C-X201
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 20

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

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Phase 1: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline

  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

  36 Weeks

• Phase 1: Percentage change in eGFR compared to baseline

  36 Weeks

• Phase 1: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.

  36 Weeks

Study Arms (10)

Phase I: Dose-finding: Group 1

EXPERIMENTAL

Drug: SCTC21C Administered SC

Biological: SCTC21C

Phase I: Dose-finding: Group 2

EXPERIMENTAL

Drug: SCTC21C Administered SC

Biological: SCTC21C

Phase I: Dose-finding: Group 3

EXPERIMENTAL

Drug: SCTC21C Administered SC

Biological: SCTC21C

Phase I: Dose-finding: Group 4

EXPERIMENTAL

Drug: SCTC21C Administered SC

Biological: SCTC21C

Phase 2: Group 1

EXPERIMENTAL

Drug: SCTC21C Administered SC

Biological: SCTC21C

Phase 2: Group 2

EXPERIMENTAL

Drug: SCTC21C Administered SC

Biological: SCTC21C

Phase I: Dose-finding: Group 5

PLACEBO COMPARATOR

Drug: SCTC21C Administered SC

Biological: SCTC21C

Phase I: Dose-finding: Group 6

PLACEBO COMPARATOR

Drug: SCTC21C Administered SC

Biological: SCTC21C

Phase 1: Dose-finding: Group 7

PLACEBO COMPARATOR

Drug: SCTC21C Administered SC

Biological: SCTC21C

Phase 2: Group 3

PLACEBO COMPARATOR

Drug: SCTC21C Administered SC

Biological: SCTC21C

Interventions

SCTC21C BIOLOGICAL

Drug: SCTC21C Administered SC

Phase 1: Dose-finding: Group 7; Phase 2: Group 1; Phase 2: Group 2; Phase 2: Group 3; Phase I: Dose-finding: Group 1; Phase I: Dose-finding: Group 2; Phase I: Dose-finding: Group 3; Phase I: Dose-finding: Group 4; Phase I: Dose-finding: Group 5; Phase I: Dose-finding: Group 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (20)

The First Affiliated Hospital of Baotou Medical College

Baotou, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital

Chengdu, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

The First Affliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Shandong Provincial Hospital

Jinan, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, China

Location

Ningbo NO.2 Hospital

Ningbo, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Shanghai General Hospital

Shanghai, China

Location

Wuxi People's Hospital

Wuxi, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, China

Location

The Second Affiliated Hospital of Xingtai Medical College

Xingtai, China

Location

Yantai Yuhuangding Hospital

Yantai, China

Location

General Hospital of Ningxia Medical University

Yinchuan, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hong Zhang

  Peking University First Hospital, Department of Nephrology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Zhou

CONTACT

+86-10-58628288; qiang_zhou@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 14, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

CN (20)