Systemic Lupus Erythematosus (SLE)Phase 2NCT07447986
To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus
A Phase 2 study testing SG301 SC Injection in people with Systemic Lupus Erythematosus (SLE), run by Hangzhou Sumgen Biotech Co., Ltd. at 40 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- SG301 SC Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 40 sitesChina
- Study dates
- 26 Mar 2026to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
40 sites in 1 country
China40 sites, 40 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Zhanguo Li, Doctor, +86-010-88378021
Yue Yang, Doctor, +86-010-88378021
- Recruiting
Jilin Provincial People's Hospital
Changchun, Jilin
Guoping Jiang, Master
- Recruiting
Jilin University First Hospital
Changchun, Jilin
Zhenyu Jiang, Doctor
- Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi
Ziqi Yuan, Master
- Recruiting
Changzhou Second People's Hospital
Changzhou, Jiangsu
Lei Zhou, Master
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Qibing Xie, Doctor
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Lin Tang, Doctor
- Recruiting
Dalian Municipal Central Hospital
Dalian, Liaoning
Bingbing Dai, Bachelor
- Recruiting
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Shanxi
Dibin Guo, Bachelor
- Recruiting
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong
Ligang Jie, Doctor
- Recruiting
The First Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Yuhong Shi, Doctor
- Not yet recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Yingnan Li, Doctor
- Recruiting
Huzhou Third People's Hospital
Huzhou, Zhejiang
Xiaobing Yang, Master
- Recruiting
JingZhou Central Hospital
Jingzhou, Hubei
Xianrong Luo, Master
- Recruiting
Jining First People's Hospital
Jining, Shandong
Shujie Li, Master
- Recruiting
The First People's Hospital of Yunnan Prevince
Kunming, Yunnan
Jing Wang, Doctor
- Recruiting
Hebei Zhongyuan Petrolium Central Hospital
Langfang, Hebei
Wei Gou, Master
- Recruiting
GanSu Provincial Hospital
Lanzhou, Gansu
shuhong Zhou, Doctor
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Yanfei Chen, Master
- Recruiting
Linfen Central Hospital
Linfen, Shanxi
Shuhua Qiang, Bachelor
- Recruiting
Luoyang Central Hospital
Luoyang, Henan
Yi Yuan, Doctor
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Xiaofei Shi, Master
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Ling Lei, Doctor
- Recruiting
Pingxiang People's Hospital
Pingxiang, Henan
Senhua Dai, Master
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong
Xiaoping Hong, Master
- Recruiting
Hebei General Hospital
Shijiazhuang, Hebei
Wei Lin, Doctor
- Recruiting
Shiyan People's Hospital
Shiyan, Hubei
Hong Tao, Master
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Zhichun Liu, Doctor
- Recruiting
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Xiaoxia Wang, Doctor
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Liyun Zhang, Doctor
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Wei Wei, Master
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Li Sun, Master
- Recruiting
The Central Hospital of Wuhan
Wuhan, Hubei
Xun Fang, Master
- Recruiting
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, Xiamen
mingshan Qiu, Master
- Recruiting
Xiamen University Affiliated Zhongshan Hospital
Xiamen, Fujian
Yuan Xue, Master
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu
Hua Wei, Doctor
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei
Xiaoqiang Hou, Master
- Recruiting
Yichun People's Hospital
Yichun, Jiangxi
Sujuan Luo, Master
- Recruiting
People's Hospital of Zhengzhou
Zhengzhou, Henan
Yunzhuan chen, Doctor
- Recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan
Jingyang Li, Master
About this study
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
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 the detailed description
This was a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. The primary objective was to evaluate the efficacy of SG301 SC Injection in participants with systemic lupus erythematosus (SLE) as assessed by the SRI-4 score. The secondary objectives included assessing the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of SG301 SC injection in these participants.
Eligible participants were those diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria, with a Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K )score of ≥ 8 points and seropositivity for antinuclear antibody (ANA) or anti-double-stranded DNA (anti-dsDNA) antibody at the screening visit.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- SG301 SC Injection, SG301 SC placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG301 SC InjectionDrug
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.
SG301 SC InjectionDrug
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
SG301 SC placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SG301 SC - A | Experimental | SG301 SC Injection Receives: Drug: SG301 SC Injection |
| SG301 SC -B | Experimental | SG301 SC Injection Receives: Drug: SG301 SC Injection |
| Placebo | Placebo comparator | SG301 SC Placebo Receives: Drug: SG301 SC placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: From baseline to week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start26 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447986
- Sponsor's protocol ID
- CSG-301 SC-205
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No