To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus
Recruiting · NCT07447986 · Interventional (participants receive a specific treatment) · Lead sponsor: Hangzhou Sumgen Biotech Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
SG301 SC InjectionSG301 SC placebo
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 .
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
- Diagnosis of mixed connective tissue disease or a history of any overlap syndrome between SLE and systemic sclerosis.
- Laboratory abnormalities.
- Current acute or chronic infection meeting any of the following criteria.
- 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).
- Use of any targeted T or B lymphocyte drugs (e.g., rituximab) within 3 months before the first dose.
- 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.
- 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.
Where it is running
40 locations listed.
- 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