SG301 subcutaneous injection for people with active lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• The Second Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Xiamen Hospital of Traditional Chinese Medicine
  Xiamen, Fujian, China Recruiting
• Xiamen University Affiliated Zhongshan Hospital
  Xiamen, Fujian, China Recruiting
• GanSu Provincial Hospital
  Lanzhou, Gansu, China Recruiting
• The First Hospital of Lanzhou University
  Lanzhou, Gansu, China Recruiting

Study contacts

• Study coordinator: Yue Song
• Email: songyue@sumgenbio.com
• Phone: +86-18511021346

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.