Tests SG301 injection in people with lupus

Trial details

Who runs it

Hangzhou Sumgen Biotech Co., Ltd.

Trial code

NCT07447986

Record updated

17 September 2026

Original description

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 .Read full original descriptionShow less

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 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 .

Inclusion: Voluntarily participate in the clinical study and sign a written informed consent form; 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; SLEDAI-2K score ≥ 8 points, with clinical features corresponding to a SLEDAI-2K score ≥ 4 points; Positive serological test results for autoantibodies, defined as antinuclear antibody (ANA) positivity and/or anti-double-stranded DNA (anti-dsDNA) antibody positivity; Body weight ≥ 35 kg; 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; 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: Previous use of CD38 or monoclonal antibodies targeting CD38; 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; 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); 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; Receipt of JAK inhibitor treatment within 2 weeks before the first dose; Diagnosis of mixed connective tissue disease or a history of any overlap syndrome between SLE and systemic sclerosis; Current acute or chronic infection meeting any of the following criteria; Presence of severe cardiovascular and cerebrovascular diseases; Mycobacterium tuberculosis infection; Presence of HIV infection, active hepatitis B, or hepatitis C; Known history of active syphilis; History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation; Other conditions that the investigator believes would prevent the participant from participating in the study; Laboratory abnormalities; Use of any targeted T or B lymphocyte drugs (e.g., rituximab) within 3 months before the first dose.

ClinicalTrials.gov NCT07447986