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
1 other identifier
interventional
120
1 country
40
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2026
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedStudy Start
First participant enrolled
March 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
September 17, 2026
February 1, 2026
1.5 years
February 25, 2026
September 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points; * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline; * No worsening in Physician's Global Assessment (PGA), defined as an increase of ≥ 0.3 from baseline;
From baseline to week 25
Study Arms (3)
SG301 SC - A
EXPERIMENTALSG301 SC Injection
SG301 SC -B
EXPERIMENTALSG301 SC Injection
Placebo
PLACEBO COMPARATORSG301 SC Placebo
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, Xiamen, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 4, 2026
Study Start
March 26, 2026
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
September 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share