Systemic Lupus Erythematosus (SLE)Phase 2NCT07760155
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Systemic Lupus Erythematosus
A Phase 2 study testing ESG206 in people with Systemic Lupus Erythematosus (SLE), run by Shanghai Escugen Biotechnology Co., Ltd at 20 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with Systemic Lupus Erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- ESG206
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 20 sitesChina
- Study dates
- 1 Sep 2026to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years of age) with a confirmed diagnosis of Systemic Lupus Erythematosus
- Evidence of active disease at screening
- Willing and able to provide written informed consent
Who cannot join
- Have other autoimmune diseases that may interfere with the assessment of SLE
- Prior or recent use of prohibited immunomodulatory therapies
- Clinically significant infections, malignancies, or uncontrolled medical conditions
- Pregnancy or breastfeeding
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites
Changde First People's Hospital
Changde, Hunan
Xiangya Hospital, Central South University
Changsha, Hunan
Hongjun Zhao, +86 731 89753999, hongjunzhao2015@sina.com
Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Affiliated Hospital of Hebei Engineering University
Handan, Hebei
Huzhou Third People's Hospital
Huzhou, Zhejiang
Jinhua Municipal Central Hospital
Jinhua, Zhejiang
Linfen Central Hospital
Linfen, Shanxi
Liupanshui Shougang Shuigang Hospital
Liupanshui, Guizhou
Loudi Central Hospital
Loudi, Hunan
Mianyang Central Hospital
Mianyang, Sichuan
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Qiong Fu, +86 21 58752345, Fuqiong5@163.com
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality
Shenzhen Third People's Hospital
Shenzhen, Guangdong
Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Xuzhou Central Hospital
Xuzhou, Jiangsu
Zhongshan Traditional Chinese Medicine Hospital
Zhongshan, Guangdong
Zhuzhou Central Hospital
Zhuzhou, Hunan
Zibo Central Hospital
Zibo, Shandong
Shujun Wang, +86 731 89753999, hongjunzhao2015@sina.com
About this study
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with Systemic Lupus Erythematosus (SLE).
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- ESG206, 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.
ESG206Drug
Anti-BAFF-R Monoclonal Antibody
ESG206Drug
Anti-BAFF-R Monoclonal Antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ESG206 High Dose | Experimental | Not described Receives: Drug: ESG206 |
| ESG206 Low Dose | Experimental | Not described Receives: Drug: ESG206 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo
Measured: Up to approximately 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2028 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Escugen Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760155
- Sponsor's protocol ID
- ESG206-SLE-01
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07760155
- Acronym / sponsor ID
- ESG206-SLE-01
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Escugen Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with Systemic Lupus Erythematosus (SLE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESG206 High Dose | Experimental | Drug: ESG206 |
| ESG206 Low Dose | Experimental | Drug: ESG206 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years of age) with a confirmed diagnosis of Systemic Lupus Erythematosus
- Evidence of active disease at screening
- Willing and able to provide written informed consent
Key exclusion criteria (4 listed)
- Have other autoimmune diseases that may interfere with the assessment of SLE
- Prior or recent use of prohibited immunomodulatory therapies
- Clinically significant infections, malignancies, or uncontrolled medical conditions
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESG206Anti-BAFF-R Monoclonal Antibody | Drug | ESG206 High Dose |
| ESG206Anti-BAFF-R Monoclonal Antibody | Drug | ESG206 Low Dose |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo
Time frame: Up to approximately 25 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ESG206 in people with Systemic Lupus Erythematosus (SLE), run by Shanghai Escugen Biotechnology Co., Ltd at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiuyue Shan Qiuyue shan (86 21 5855 6098, zhaoyonggang@escugen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo (time frame: Up to approximately 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.