🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07727486
Starting soon Phase 2

A Study to Evaluate the Efficacy and Safety of ICP-488 in Participants With Primary Sjögren's Syndrome

NCT07727486 · tracked via the Priya Life Science China tracker
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Phase
Phase 2
Started
2026-08
Last updated
2026-07-27

Condition(s) studied

Primary Sjögren's Syndrome

Investigational drug(s) / intervention(s)

ICP-488 Tablets →ICP-488 Placebo

ICP-488 Tablets: Specified dose on specified days

ICP-488 Placebo: Specified dose on specified days

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria 1. Aged 18 to 70 years inclusive. 2. The disease duration (from the date of diagnosis) prior to screening shall be at least 24 weeks and no more than 5 years.. 3. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at screening is ≥ 5. 4. At screening, the stimulated whole salivary flow (SWSF) ≥ 0.05 mL/min OR unstimulated whole salivary flow (UWSF) ≥ 0.01 mL/min. 5. Positive for anti-Sjögren's-syndrome-related antigen A (anti-SSA/Ro) antibodies at screening. 6. Stable treatment regimen that can be continued until the end of study treatment (Week 48). 7. 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. 8. 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. Exclusion Criteria 1. SjS secondary to other systemic autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis). 2. Other autoimmune or inflammatory diseases that could interfere with the assessment of treatment response in SjS. 3. Presence of any other medical condition associated with SjS symptoms. 4. Participants with a history of any clinically significant disease other than pSjS. 5. Significant ECG abnormalities at screening requiring treatment. 6. 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. 7. Current or past history of bleeding disorders or diseases related to platelet dysfunction. 8. Severe infection (bacterial, fungal, or viral) requiring hospitalization within 60 days prior to screening. 9. 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. 10. Participants considered by the investigator to be unsuitable for participation in this study for any reason.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Peking Beijing Beijing Municipality
Chongqing Traditional Chinese Medicine Hospital Chongqing Chongqing Municipality
"Southwest Hospital, Army Medical University (The First Hospital Affiliated to Army Medical University)" Chongqing Chongqing Municipality
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
The Second Hospital of Hebei Medical University Shijiazhuang Hebei
Xiangya Hospital of Central South University Changsha Hunan
Zhuzhou Central Hospital Zhuzhou Hunan
"Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School" Nanjin Jiangsu
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
Pingxiang People's Hospital Pingxiang Jiangxi
Bethune First Hospital of Jilin University Changchun Jilin
Renji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
West China Hospital of Sichuan University Chengdu Sichuan
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital Chengdu Sichuan
Tianjin First Central Hospital Tianjin Tianjin Municipality
The First Affiliated Hospital of Kunming Medical University Kunming Yunnan
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
Jinhua Municipal Central Hospital Jinhua Zhejiang

More Beijing InnoCare Pharma Tech Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07727486 on ClinicalTrials.gov ↗ ← All trials in China