Primary Sjögren SyndromePhase 2NCT07375524
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome
A Phase 2 study testing ESG206 in people with Primary Sjögren Syndrome, run by Shanghai Escugen Biotechnology Co., Ltd at 21 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 primary Sjögren's syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren Syndrome
- What is being tested?
- ESG206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 21 sitesChina
- Study dates
- 1 Mar 2026to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years of age) with a confirmed diagnosis of primary Sjögren's syndrome according to the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
- Evidence of active disease at screening
- Willing and able to provide written informed consent
Who cannot join
- Secondary Sjögren's syndrome or other clinically significant autoimmune or inflammatory diseases
- Prior or recent use of prohibited immunomodulatory therapies
- Clinically significant infections, malignancies, or uncontrolled medical conditions
- Pregnancy or breastfeeding
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Peking University Shougang Hospital
Beijing, Beijing Municipality
Changde First People's Hospital
Changde, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Huzhou Third People's Hospital
Huzhou, Zhejiang
Qilu Hospital of Shandong University
Jinan, Shandong
Jinhua Municipal Central Hospital
Jinhua, Zhejiang
Affiliated Hospital of Jining Medical University
Jining, Shandong
Hebei Petro China Central Hospital
Langfang, Hebei
the Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan
Pingxiang People's Hospital
Pingxiang, Jiangxi
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Leading PI, 86 21 58752345, Fuqiong5@163.com
co Leading PI, hongjunzhao2015@sina.com
Wenzhou People's Hospital
Wenzhou, Zhejiang
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Xuzhou Central Hospital
Xuzhou, Jiangsu
Zaozhuang Municipal Hospital
Zaozhuang, Shandong
Zhuzhou Central Hospital
Zhuzhou, Hunan
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 primary Sjögren's syndrome.
- Conditions
- Primary Sjögren Syndrome
- Being tested
- ESG206, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESG206Drug
ESG206 Low Dose administered by intravenous infusion
ESG206Drug
ESG206 High Dose administered by intravenous infusion
PlaceboDrug
Placebo administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ESG206 Low Dose | Active comparator | ESG206 Low Dose Injection administered by intravenous infusion Receives: Drug: ESG206 |
| ESG206 High Dose | Active comparator | ESG206 High Dose Injection administered by intravenous infusion Receives: Drug: ESG206 |
| Placebo | Placebo comparator | Placebo Injection administered by intravenous infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ESSDAI score compared with placebo.
ESSDAI is a validated clinical disease activity index for Sjögren's syndrome. It includes 12 organ-specific domains, each scored by the investigator according to severity using 3- or 4-level scales. Weighted domain scores are summed to generate a total score (maximum score: 123). Domains include constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological, and biological domains. Higher scores on the ESSDAI scale are associated with poorer health states.
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 posted29 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren SyndromeStudies 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
- NCT07375524
- Sponsor's protocol ID
- ESG206-PSS-01
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 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 Primary Sjogren Syndrome
- ClinicalTrials.gov ID
- NCT07375524
- Acronym / sponsor ID
- ESG206-PSS-01
- Conditions
- Primary Sjögren Syndrome
- 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 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Jan 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 primary Sjögren's syndrome.
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 Low Dose | Active comparator | Drug: ESG206ESG206 Low Dose Injection administered by intravenous infusion |
| ESG206 High Dose | Active comparator | Drug: ESG206ESG206 High Dose Injection administered by intravenous infusion |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Injection administered by intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- 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 primary Sjögren's syndrome according to the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
- Evidence of active disease at screening
- Willing and able to provide written informed consent
Key exclusion criteria (4 listed)
- Secondary Sjögren's syndrome or other clinically significant autoimmune or inflammatory diseases
- 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 |
|---|---|---|
| ESG206ESG206 Low Dose administered by intravenous infusion | Drug | ESG206 High Dose |
| ESG206ESG206 High Dose administered by intravenous infusion | Drug | ESG206 Low Dose |
| PlaceboPlacebo administered by intravenous infusion | Drug | Placebo |
Primary outcome
Change from baseline in ESSDAI score compared with placebo.
Time frame: Up to approximately 25 weeks
ESSDAI is a validated clinical disease activity index for Sjögren's syndrome. It includes 12 organ-specific domains, each scored by the investigator according to severity using 3- or 4-level scales. Weighted domain scores are summed to generate a total score (maximum score: 123). Domains include constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological, and biological domains. Higher scores on the ESSDAI scale are associated with poorer health states.
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 3 Feb 2026.
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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.
21 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 Primary Sjögren Syndrome, run by Shanghai Escugen Biotechnology Co., Ltd at 21 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 Qing Zhou, PhD (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?
Change from baseline in ESSDAI score 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 3 Feb 2026.