To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SG301 SC Injection in Patients With Systemic Lupus Erythematosus

To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus (NCT07447986) is a Phase 2 interventional studying Systemic Lupus Erythematosus (SLE), sponsored by Hangzhou Sumgen Biotech Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study. The primary objective was to evaluate the efficacy of SG301 SC injection in participants with Systemic Lupus Erythematosus (SLE) based on the Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response rate. The secondary objectives were to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of SG301 SC injection in these participants .

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Systemic Lupus Erythematosus (SLE) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Systemic Lupus Erythematosus (SLE) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily participate in the clinical study and sign a written willing to sign a consent form form. 2. Participants must be diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatism (ACR) SLE classification criteria and have inadequate response to standard treatment, intolerance to standard treatment, or recurrent disease. 3. SLEDAI-2K score ≥ 8 points, with clinical features corresponding to a SLEDAI-2K score ≥ 4 points. 4. Positive serological test results for autoantibodies, defined as antinuclear antibody (ANA) positivity and/or anti-double-stranded DNA (anti-dsDNA) antibody positivity. 5. Body weight ≥ 35 kg. 6. Must have received standard treatment for at least 8 weeks before the first dose and maintained a stable dose of the treatment unchanged for at least 4 weeks before the first dose. 7. Participants of childbearing potential or whose partners are of childbearing potential must agree to use effective contraceptive measures throughout the entire study period and within 6 months after the last dose. Who Should NOT Join This Trial: 1. Previous use of CD38 or monoclonal antibodies targeting CD38. 2. Active central nervous system (CNS) disease within 2 months before the first dose, or CNS disease that the investigator believes may require treatment with prohibited therapies specified in the protocol. 3. Diagnosis of mixed connective tissue disease or a history of any overlap syndrome between SLE and systemic sclerosis. 4. Laboratory abnormalities. 5. Current acute or chronic infection meeting any of the following criteria. 6. Participation in any other clinical trial within 4 weeks before the first dose (excluding participants who provided willing to sign a consent form but did not receive trial treatment, or only received placebo). 7. Use of any targeted T or B lymphocyte drugs (e.g., rituximab) within 3 months before the first dose. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Voluntarily participate in the clinical study and sign a written informed consent form. 2. Participants must be diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatism (ACR) SLE classification criteria and have inadequate response to standard treatment, intolerance to standard treatment, or recurrent disease. 3. SLEDAI-2K score ≥ 8 points, with clinical features corresponding to a SLEDAI-2K score ≥ 4 points. 4. Positive serological test results for autoantibodies, defined as antinuclear antibody (ANA) positivity and/or anti-double-stranded DNA (anti-dsDNA) antibody positivity. 5. Body weight ≥ 35 kg. 6. Must have received standard treatment for at least 8 weeks before the first dose and maintained a stable dose of the treatment unchanged for at least 4 weeks before the first dose. 7. Participants of childbearing potential or whose partners are of childbearing potential must agree to use effective contraceptive measures throughout the entire study period and within 6 months after the last dose. Exclusion Criteria: 1. Previous use of CD38 or monoclonal antibodies targeting CD38. 2. Active central nervous system (CNS) disease within 2 months before the first dose, or CNS disease that the investigator believes may require treatment with prohibited therapies specified in the protocol. 3. Diagnosis of mixed connective tissue disease or a history of any overlap syndrome between SLE and systemic sclerosis. 4. Laboratory abnormalities. 5. Current acute or chronic infection meeting any of the following criteria. 6. Participation in any other clinical trial within 4 weeks before the first dose (excluding participants who provided informed consent but did not receive trial treatment, or only received placebo). 7. Use of any targeted T or B lymphocyte drugs (e.g., rituximab) within 3 months before the first dose. 8. Receipt of any B cell-depleting drugs (such as belimumab, telitacicept) within 4 weeks or 5 half-lives (whichever is shorter) before the first dose. 9. Receipt of JAK inhibitor treatment within 2 weeks before the first dose. 10. Presence of severe cardiovascular and cerebrovascular diseases. 11. Mycobacterium tuberculosis infection. 12. Presence of HIV infection, active hepatitis B, or hepatitis C. 13. Known history of active syphilis. 14. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation. 15. Other conditions that the investigator believes would prevent the participant from participating in the study.

Treatments Being Tested

DRUG

SG301 SC Injection

One injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered.

DRUG

SG301 SC Injection

One injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered, among which 2 injections are placebos

DRUG

SG301 SC placebo

One injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University People's Hospital

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07447986), the sponsor (Hangzhou Sumgen Biotech Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07447986 clinical trial studying?

Who can participate in NCT07447986?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07447986?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07447986. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07447986. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.