SG301 subcutaneous injection for people with active lupus

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

This study will test whether SG301, given as an under-the-skin injection, can help people with active, autoantibody-positive systemic lupus erythematosus who have not adequately responded to standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: rituximab, belimumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07447986 on ClinicalTrials.gov

What this trial studies

This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 study comparing SG301 given subcutaneously to placebo in participants with active SLE. Eligible participants met the 2019 EULAR/ACR classification for SLE, were seropositive for ANA or anti-dsDNA, and had a SLEDAI-2K score of at least 8 while on stable background therapy. The primary efficacy measure was the SRI-4 response rate; secondary assessments included safety, pharmacokinetics, pharmacodynamics, and immunogenicity. Participants received SG301 or placebo while continuing stable standard-of-care therapy under close monitoring.

Who should consider this trial

Good fit: Ideal candidates are people diagnosed with SLE by the 2019 EULAR/ACR criteria who are ANA or anti-dsDNA positive, have an SLEDAI-2K score ≥ 8, weigh at least 35 kg, and have had an inadequate response to or intolerance of standard treatment while on a stable regimen.

Not a fit: People with mild disease activity (SLEDAI-2K < 8), who are seronegative, who are pregnant, or who have not tried or stabilized standard therapies are unlikely to match this study's eligibility and therefore may not benefit from participation.

Why it matters

Potential benefit: If effective, SG301 could lower disease activity and reduce flares, improving symptoms and daily function for people with active, autoantibody-positive SLE.

How similar studies have performed: Other biologic therapies for SLE (for example, belimumab and anifrolumab) have shown benefit in controlled trials, but SG301 appears to be a novel agent with limited published phase 2 data to date.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yue Song

Conditions Systemic Lupus Erythematosus