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RECRUITING

NCT07447986

PHASE2

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

Sponsor: Hangzhou Sumgen Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

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 .

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-03-26

Completion Date

2027-12-31

Last Updated

2026-08-19

Healthy Volunteers

Conditions

Systemic Lupus Erythematosus (SLE)

Interventions

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.

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.

Locations (41)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Xiamen University Affiliated Zhongshan Hospital

Xiamen, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

The First Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Liujiang City People's Hospital

Liuzhou, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Hebei Zhongyuan Petrolium Central Hospital

Langfang, Hebei, China

Hebei General Hospital

Shijiazhuang, Hebei, China

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Luoyang Central Hospital

Luoyang, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Pingxiang People's Hospital

Pingxiang, Henan, China

Shiyan People's Hospital

Shiyan, Hubei, China

The Central Hospital of Wuhan

Wuhan, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Zhuzhou Central Hospital

Zhuzhou, Hunan, China

Changzhou Second People's Hospital

Changzhou, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Yichun People's Hospital

Yichun, Jiangxi, China

Jilin Provincial People's Hospital

Changchun, Jilin, China

Jilin University First Hospital

Changchun, Jilin, China

Dalian Central Hospital

Dalian, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Jining First People's Hospital

Jining, Shandong, China

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

The First Affiliated Hospital of Gannan Medical University

Ganzhou, Shanxi, China

Linfen Central Hospital

Linfen, Shanxi, China

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

The First People's Hospital of Yunnan Prevince

Kunming, Yunnan, China

Huzhou Third People's Hospital

Huzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (41)