A Study to Evaluate the Efficacy and Safety of ICP-488 in Participants With Primary Sjögren's Syndrome
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)
1 other identifier
interventional
240
1 country
22
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2026
22 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
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
July 27, 2026
July 1, 2026
2.3 years
July 21, 2026
July 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24
Baseline, Week 24
Secondary Outcomes (10)
Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period.
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.
Baseline, Week 24
Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period.
Baseline, Week 24
Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period.
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.
Baseline, Week 24
- +5 more secondary outcomes
Study Arms (4)
ICP-488 Dose A
EXPERIMENTALICP-488 Dose B
EXPERIMENTALICP-488 Dose C
EXPERIMENTALICP-488 Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Peking
Beijing, Beijing Municipality, 100034, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400011, China
"Southwest Hospital, Army Medical University （The First Hospital Affiliated to Army Medical University）"
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050005, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
"Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School"
Nanjin, Jiangsu, 210008, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Bethune First Hospital of Jilin University
Changchun, Jilin, 130021, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300192, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2026
First Posted
July 27, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
July 27, 2026
Record last verified: 2026-07