Primary Sjögren's SyndromePhase 2NCT07727486
A Study to Evaluate the Efficacy and Safety of ICP-488 in Participants With Primary Sjögren's Syndrome
A Phase 2 study testing ICP-488 Tablets in people with Primary Sjögren's Syndrome, run by Beijing InnoCare Pharma Tech Co., Ltd. at 22 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in participants with primary Sjögren's syndrome (pSjS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- ICP-488 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 22 sitesChina
- Study dates
- Aug 2026to Mar 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years inclusive.
- The disease duration (from the date of diagnosis) prior to screening shall be at least 24 weeks and no more than 5 years..
- The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at screening is ≥ 5.
- At screening, the stimulated whole salivary flow (SWSF) ≥ 0.05 mL/min OR unstimulated whole salivary flow (UWSF) ≥ 0.01 mL/min.
- Positive for anti-Sjögren's-syndrome-related antigen A (anti-SSA/Ro) antibodies at screening.
- Stable treatment regimen that can be continued until the end of study treatment (Week 48).
- Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception correctly during the study treatment period and for 1 month (28 days) after the last dose.
- Male participants with a WOCBP partner must agree to use protocol-specified contraceptive methods during the study treatment period and for 3 days after the last dose.
Who cannot join
- SjS secondary to other systemic autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis).
- Other autoimmune or inflammatory diseases that could interfere with the assessment of treatment response in SjS.
- Presence of any other medical condition associated with SjS symptoms.
- Participants with a history of any clinically significant disease other than pSjS.
- Significant ECG abnormalities at screening requiring treatment.
- Participants with gastrointestinal diseases or gastrointestinal surgery present within 3 months prior to the screening visit that could affect the absorption of the study drug.
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- Current or past history of bleeding disorders or diseases related to platelet dysfunction.
- Severe infection (bacterial, fungal, or viral) requiring hospitalization within 60 days prior to screening.
- Participants with any uncontrolled clinically significant laboratory abnormality that, in the opinion of the investigator, could affect the interpretation of study data or the participant's participation in the study.
- Participants considered by the investigator to be unsuitable for participation in this study for any reason.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites
Peking
Beijing, Beijing Municipality, 100034
Zhuoli Zhang, zhuoli.zhang@126.com
Bethune First Hospital of Jilin University
Changchun, Jilin, 130021
Zhenyu Jiang, jzyd0197@163.com
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Hui Luo, luohuihn@sina.com
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Qibing Xie, xqb_fsmygcp@126.com
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Xiaodan Wu, 13008126525@163.com
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400011
Chengyin Li, lichengyinnihao@126.com
"Southwest Hospital, Army Medical University （The First Hospital Affiliated to Army Medical University）"
Chongqing, Chongqing Municipality, 400038
Bing Zhong, dune_zhong@163.com
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Yingqian Mo, toqianye@163.com
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Yunfeng Pan, p-yunfeng@163.com
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Huaxiang Wu, wuhx8855@sina.com
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000
Li Hua, 49124571@qq.com
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Jian Xu, casxujian@126.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Rui Wu, tcmclinic@163.com
"Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School"
Nanjin, Jiangsu, 210008
Lingyun Sun, lingyunsun2012@163.com
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Jing Wen, 475110698@qq.com
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
Jiankang Hu, hjk0799@126.com
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001
Ting Li, leeting007@163.com
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050005
Huifang Guo, 18531135182@163.com
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Zhichun Liu, lzchun5190@sina.com
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300192
Chunyu Kong, kongchunyu72@aliyun.com
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Guixiu Shi, gshi@xmu.edu.cn
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007
Zhenhua Wen, 151728544@qq.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Participants With Primary Sjögren's Syndrome (pSjS)
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in participants with primary Sjögren's syndrome (pSjS).
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- ICP-488 Tablets, ICP-488 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-488 TabletsDrug
Specified dose on specified days
ICP-488 PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| ICP-488 Dose A | Experimental | Not described Receives: Drug: ICP-488 Tablets |
| ICP-488 Dose B | Experimental | Not described Receives: Drug: ICP-488 Tablets |
| ICP-488 Dose C | Experimental | Not described Receives: Drug: ICP-488 Tablets |
| ICP-488 Placebo | Placebo comparator | Not described Receives: Drug: ICP-488 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24
Measured: Baseline, Week 24
Secondary outcomes (10)
Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period.
Measured: Baseline, Week 24
Percentage (%) of participants achieving a reduction from baseline in ESSDAI of ≥3 points at each scheduled visit during the 24-week treatment period.
Measured: Baseline, Week 24
Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period.
Measured: Baseline, Week 24
Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period.
Measured: Baseline, Week 24
Percentage (%) of participants achieving a reduction from baseline in ESSPRI of ≥1 point or 15% at each scheduled visit during the 24-week treatment period.
Measured: Baseline, Week 24
Treatment-emergent adverse events.
Measured: Through study completion, an average of 1 year
Incidence of clinically significant abnormalities in laboratory test results, electrocardiograms (ECGs), vital signs, etc., and changes from baseline.
Measured: Through study completion, an average of 1 year
Maximum Concentration at Steady State(Cmax,ss)
Measured: Through study completion, an average of 1 year
Steady-State Time to Maximum
Measured: Through study completion, an average of 1 year
Area under the curve (AUC)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727486
- Sponsor's protocol ID
- ICP-CL-01010
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Participants With Primary Sjögren's Syndrome (pSjS)
- ClinicalTrials.gov ID
- NCT07727486
- Acronym / sponsor ID
- ICP-CL-01010
- Conditions
- Primary Sjögren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 27 Jul 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 clinical study to evaluate the efficacy and safety of ICP-488 in participants with primary Sjögren's syndrome (pSjS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICP-488 Dose A | Experimental | Drug: ICP-488 Tablets |
| ICP-488 Dose B | Experimental | Drug: ICP-488 Tablets |
| ICP-488 Dose C | Experimental | Drug: ICP-488 Tablets |
| ICP-488 Placebo | Placebo comparator | Drug: ICP-488 Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 to 70 years inclusive.
- The disease duration (from the date of diagnosis) prior to screening shall be at least 24 weeks and no more than 5 years..
- The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at screening is ≥ 5.
- At screening, the stimulated whole salivary flow (SWSF) ≥ 0.05 mL/min OR unstimulated whole salivary flow (UWSF) ≥ 0.01 mL/min.
- Positive for anti-Sjögren's-syndrome-related antigen A (anti-SSA/Ro) antibodies at screening.
Key exclusion criteria (10 listed)
- SjS secondary to other systemic autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis).
- Other autoimmune or inflammatory diseases that could interfere with the assessment of treatment response in SjS.
- Presence of any other medical condition associated with SjS symptoms.
- Participants with a history of any clinically significant disease other than pSjS.
- Significant ECG abnormalities at screening requiring treatment.
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 |
|---|---|---|
| ICP-488 TabletsSpecified dose on specified days | Drug | ICP-488 Dose A, ICP-488 Dose B, ICP-488 Dose C |
| ICP-488 PlaceboSpecified dose on specified days | Drug | ICP-488 Placebo |
Primary outcome
Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24
Time frame: Baseline, Week 24
10 secondary outcomes
Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Percentage (%) of participants achieving a reduction from baseline in ESSDAI of ≥3 points at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Percentage (%) of participants achieving a reduction from baseline in ESSPRI of ≥1 point or 15% at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Treatment-emergent adverse events.
Time frame: Through study completion, an average of 1 year
Incidence of clinically significant abnormalities in laboratory test results, electrocardiograms (ECGs), vital signs, etc., and changes from baseline.
Time frame: Through study completion, an average of 1 year
Maximum Concentration at Steady State(Cmax,ss)
Time frame: Through study completion, an average of 1 year
Steady-State Time to Maximum
Time frame: Through study completion, an average of 1 year
Area under the curve (AUC)
Time frame: Through study completion, an average of 1 year
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 27 Jul 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.
22 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 ICP-488 Tablets in people with Primary Sjögren's Syndrome, run by Beijing InnoCare Pharma Tech Co., Ltd. at 22 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 8 inclusion and 10 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 Alexia Lu (010-66609745, CO_HGRAC@innocarepharma.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 EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24 (time frame: Baseline, Week 24). 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 27 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.