A Clinica Study of SCTC21C in Participants With Systemic Lupus Erythematosus

April 12, 2026 updated by: Sinocelltech Ltd.

A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTC21C in Participants With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study contains phase Ib and phase II studies. In phase Ib study, participants will be assigned to receive sequentially higher doses of SCTC21C to determine the recomended dose of SCTC21C for the randomized dose optimation-stage. In phase 2 study, 2 dose levels will be uased. A total of 120 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
159

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18-75 years;
  2. Diagnosed with SLE for ≥12 weeks prior to screening, met the 2019 ACR/EULAR diagnostic criteria for SLE screening period;
  3. SELENA-SLEDAI ≥8 at screening;
  4. Positive immunological markers within 12 months prior to baseline;
  5. Currently receiving ≥1 stable doses of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs;
  6. All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 5 months after the last dose of the study drug
  7. Understanding of the study procedures and voluntary signing of the informed consent form

Exclusion Criteria:

  1. Severe active or unstable lupus-related neuropsychiatric disorders;
  2. Combined with active infections, malignant tumors, or other autoimmune diseases;
  3. Catastrophic antiphospholipid syndrome;
  4. severe lupus nephritis;
  5. Study participants who received a live or attenuated vaccine within 28 days prior to baseline or during the screening period;
  6. Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);
  7. Patients at high risk of severe clinical bleeding, or those requiring plasma transfusion, intravenous immunoglobulin, or acute blood products;;
  8. Patients who experienced any of the following cardiovascular or cerebrovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association (NYHA) Class II or higher heart failure, stroke, etc.;
  9. In accordance with the protocol requirements, participants with abnormal laboratory test results;
  10. Participants with positive results of viral serology, including Treponema pallidum, HIV, HCV, and HBV;
  11. participants with a history of tuberculosis or latent tuberculosis infection;
  12. Diagnosed with type 1 or type 2 diabetes with poor control;
  13. Uncontrolled hypertension;
  14. Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTC21C injection;
  15. Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;
  16. History of solid organ or hematopoietic stem cell/bone marrow transplant, or expected to undergo transplant surgery during the study;
  17. Pregnant or breastfeeding;
  18. Any other condition that the investigator deems unsuitable for participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental: SCTC21C
SCTC21C will be administered to participants for about 24 weeks
Biological: SCTC21C
SCTC21C will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTC21C will be applied for the dose-expansion cohorts

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 1: safety and tolerability of SCTC21C
Time Frame: From first dose to Week 48
To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE) and dose-limiting toxicity (DLT)
From first dose to Week 48
Phase II: efficacy of SCTC21C
Time Frame: Up to Week 24
Percentage of participants who achiened an mSRI-4 response at W24
Up to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
dose escalation part#SRI4/5/6/7/8
Time Frame: up to Week 48
percentage of participants who achieved SRI4/5/6/7/8 response at specified time
up to Week 48
Dose- escalation # mSRI4/5/6/7/8
Time Frame: up to Week 48
percentage of participants who achieved mSRI4/5/6/7/8 response at specified time
up to Week 48
Dose-escalation part # BILAG
Time Frame: up to Week 48
The BILAG improvement rate among participants with baseline BILAG score of A or B at specified time
up to Week 48
Dose-escalation part # SLE flare
Time Frame: Up to Week 48
Time to first SLE flare
Up to Week 48
Dose-escalation part # immunogenicity
Time Frame: up to Week 48
Serum anti-SCTC21C antibody and anti-SCTC21C neutralization antibody levels
up to Week 48
Dose-escalation part # SCTC21C
Time Frame: up to Week 48
Serum SCTC21C levels at specified time
up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinocelltech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCTC21C-C201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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