RecruitingPhase 2NCT07447986

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

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

Sponsor

Hangzhou Sumgen Biotech Co., Ltd.

Enrollment

120 participants

Start Date

Mar 26, 2026

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus (SLE)

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 .

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SG301 SC Injection, a drug called SG301 SC Injection, and others for people with systemic lupus erythematosus (sle). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSG301 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.

DRUGSG301 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

DRUGSG301 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.

Locations(40)

Peking University People's Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, Fujian, China

Xiamen University Affiliated Zhongshan Hospital

Xiamen, Fujian, China

GanSu Provincial Hospital

Lanzhou, Gansu, 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

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

People's Hospital of Zhengzhou

Zhengzhou, Henan, China

JingZhou Central Hospital

Jingzhou, Hubei, China

Shiyan People's Hospital

Shiyan, Hubei, China

The Central Hospital of Wuhan

Wuhan, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, 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 Municipal Central Hospital

Dalian, Liaoning, China

Jining First People's Hospital

Jining, Shandong, 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

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NCT07447986

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