Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07447986

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

Led by Hangzhou Sumgen Biotech Co., Ltd. · Updated on 2026-04-02

120

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily participate in the clinical study and sign a written informed consent form.
  • Diagnosed with SLE per 2019 EULAR/ACR classification criteria with inadequate response, intolerance, or recurrent disease.
  • SLE Disease Activity Index - 2000 (SLEDAI-2K) score of 8 or higher, with clinical features scoring at least 4 points.
  • Positive antinuclear antibody (ANA) and/or anti-double-stranded DNA (anti-dsDNA) antibody test results.
  • Body weight of at least 35 kg.
  • Received standard treatment for at least 8 weeks before first dose with a stable dose for at least 4 weeks.
  • Agree to use effective contraception during the study and for 6 months after last dose if of childbearing potential or partnered with someone who is.
Not Eligible

You will not qualify if you...

  • Previous use of CD38 or monoclonal antibodies targeting CD38.
  • Active central nervous system (CNS) disease within 2 months before first dose or requiring prohibited therapies.
  • Diagnosis of mixed connective tissue disease or overlap syndrome between SLE and systemic sclerosis.
  • Laboratory abnormalities.
  • Current acute or chronic infection meeting specified criteria.
  • Participation in another clinical trial within 4 weeks before first dose, except informed consent only or placebo.
  • Use of targeted T or B lymphocyte drugs (e.g., rituximab) within 3 months before first dose.
  • Use of B cell-depleting drugs (e.g., belimumab, telitacicept) within 4 weeks or 5 half-lives before first dose.
  • JAK inhibitor treatment within 2 weeks before first dose.
  • Severe cardiovascular or cerebrovascular diseases.
  • Mycobacterium tuberculosis infection.
  • HIV infection, active hepatitis B, or hepatitis C.
  • Known active syphilis.
  • History of major organ or hematopoietic stem cell/bone marrow transplantation.
  • Other conditions deemed by investigators to prevent participation.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

Y

Yue Song

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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