IgA NephropathyPhase 1/2NCT06774664
A Clinical Study of SCTC21C in Participants With Plasma Cell-driven Autoimmune Diseases
A Phase 1/2 study testing SCTC21C in people with IgA Nephropathy, run by Sinocelltech Ltd. at 20 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- SCTC21C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 20 sitesChina
- Study dates
- Jan 2025to Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.;
Show all 12Show fewer
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites
The First Affiliated Hospital of Baotou Medical College
Baotou
Beijing Tsinghua Changgung Hospital
Beijing
Yuehong Li
Peking University First Hospital
Beijing
Jicheng Lv
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu
Fang Wang
Guangdong Provincial People's Hospital
Guangzhou
Zhiming Ye
The First Affliated Hospital, Zhejiang University School of Medicine
Hangzhou
Fei Han
Zhejiang Provincial People's Hospital
Hangzhou
Bin Zhu
Shandong Provincial Hospital
Jinan
Rong Wang
The First Affiliated Hospital of Nanchang University
Nanchang
The Second Affiliated Hospital of Nanchang University
Nanchang
Gaosi Xu
Guangxi Zhuang Autonomous Region People's Hospital
Nanning
Lijia Xiong
Huijuan Li
Ningbo NO.2 Hospital
Ningbo
Qun Luo
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Jingyuan Xie
Shanghai General Hospital
Shanghai
Qiuling Fan
Wuxi People's Hospital
Wuxi
Liang Wang
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an
Jiping Sun
The First Affiliated Hospital of Xiamen University
Xiamen
Leping Shao
The Second Affiliated Hospital of Xingtai Medical College
Xingtai
Huixiao Zheng
Yantai Yuhuangding Hospital
Yantai
Peng Li
General Hospital of Ningxia Medical University
Yinchuan
Menghua Chen
About this study
Official title: 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
Read the 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.
- Conditions
- IgA Nephropathy
- Being tested
- SCTC21C
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTC21CBiological
Drug: SCTC21C Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose-finding: Group 1 | Experimental | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
| Phase I: Dose-finding: Group 2 | Experimental | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
| Phase I: Dose-finding: Group 3 | Experimental | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
| Phase I: Dose-finding: Group 4 | Experimental | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
| Phase 2: Group 1 | Experimental | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
| Phase 2: Group 2 | Experimental | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
| Phase I: Dose-finding: Group 5 | Placebo comparator | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
| Phase I: Dose-finding: Group 6 | Placebo comparator | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
| Phase 1: Dose-finding: Group 7 | Placebo comparator | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
| Phase 2: Group 3 | Placebo comparator | Drug: SCTC21C Administered SC Receives: Biological: SCTC21C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 Weeks
Secondary outcomes (18)
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.
Measured: 36 Weeks
Phase 1: Percentage change in 24-hour urinary protein excretion compared to baseline
Measured: 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.
Measured: 36 Weeks
Phase 1: Percentage change in eGFR compared to baseline
eGFR is calculated using the CKD-EPI formula.
Measured: 36 Weeks
Phase 1: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.
Measured: 36 Weeks
Phase 1: C-max
Maximum observed plasma concentration
Measured: 24 Weeks
Phase 1: T1/2
apparent terminal half-life
Measured: 24 Weeks
Phase 1: AUC0-t
area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
Measured: 24 Weeks
Phase 1: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)
Results for ADA analysis were reported.
Measured: 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.
Measured: 104 Weeks
Phase 2: Percentage change in 24-hour urinary protein excretion compared to baseline
Measured: 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.
Measured: 104 Weeks
Phase 2: Percentage change in eGFR compared to baseline
eGFR is calculated using the CKD-EPI formula.
Measured: 104 Weeks
Phase 2: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.
Measured: 104 Weeks
Phase 2: C-max
Maximum observed plasma concentration
Measured: 32 Weeks
Phase 2: T1/2
apparent terminal half-life
Measured: 32 Weeks
Phase 2: AUC0-t
area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
Measured: 32 Weeks
Phase 2: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)
Results for ADA analysis were reported.
Measured: 104 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Zhang, Principal investigator, Peking University First Hospital, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774664
- Sponsor's protocol ID
- SCTC21C-X201
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06774664
- Acronym / sponsor ID
- SCTC21C-X201
- Conditions
- IgA Nephropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose-finding: Group 1 | Experimental | Biological: SCTC21CDrug: SCTC21C Administered SC |
| Phase I: Dose-finding: Group 2 | Experimental | Biological: SCTC21CDrug: SCTC21C Administered SC |
| Phase I: Dose-finding: Group 3 | Experimental | Biological: SCTC21CDrug: SCTC21C Administered SC |
| Phase I: Dose-finding: Group 4 | Experimental | Biological: SCTC21CDrug: SCTC21C Administered SC |
| Phase 2: Group 1 | Experimental | Biological: SCTC21CDrug: SCTC21C Administered SC |
| Phase 2: Group 2 | Experimental | Biological: SCTC21CDrug: SCTC21C Administered SC |
| Phase I: Dose-finding: Group 5 | Placebo comparator | Biological: SCTC21CDrug: SCTC21C Administered SC |
| Phase I: Dose-finding: Group 6 | Placebo comparator | Biological: SCTC21CDrug: SCTC21C Administered SC |
| Phase 1: Dose-finding: Group 7 | Placebo comparator | Biological: SCTC21CDrug: SCTC21C Administered SC |
| Phase 2: Group 3 | Placebo comparator | Biological: SCTC21CDrug: SCTC21C Administered SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTC21CDrug: SCTC21C Administered SC | Biological | 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 |
Primary outcome
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.
18 secondary outcomes
Phase 1: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline
Time frame: 36 Weeks
Phase 1: Percentage change in 24-hour urinary protein excretion compared to baseline
Time frame: 36 Weeks
Phase 1: Percentage change in urine albumin-to-creatinine ratio (UACR) compared to baseline
Time frame: 36 Weeks
Phase 1: Percentage change in eGFR compared to baseline
Time frame: 36 Weeks
Phase 1: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.
Time frame: 36 Weeks
Phase 1: C-max
Time frame: 24 Weeks
Phase 1: T1/2
Time frame: 24 Weeks
Phase 1: AUC0-t
Time frame: 24 Weeks
Phase 1: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)
Time frame: 36 Weeks
Phase 2: Percentage change in urine protein-to-creatinine ratio (UPCR) compared to baseline
Time frame: 104 Weeks
Phase 2: Percentage change in 24-hour urinary protein excretion compared to baseline
Time frame: 104 Weeks
Phase 2: Percentage change in urine albumin-to-creatinine ratio (UACR) excretion compared to baseline
Time frame: 104 Weeks
Phase 2: Percentage change in eGFR compared to baseline
Time frame: 104 Weeks
Phase 2: Change from baseline in Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG), etc.
Time frame: 104 Weeks
Phase 2: C-max
Time frame: 32 Weeks
Phase 2: T1/2
Time frame: 32 Weeks
Phase 2: AUC0-t
Time frame: 32 Weeks
Phase 2: Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)
Time frame: 104 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong Zhang principal investigator
Peking University First Hospital, Department of Nephrology
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCTC21C in people with IgA Nephropathy, run by Sinocelltech Ltd. at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Zhou (+86-10-58628288, qiang_zhou@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs). (time frame: 36 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.