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)
Change from baseline in EULAR sjögren's syndrome disease activity index(ESSDAI ) at Week 24 — Baseline, Week 24
Trial sites (22)
Facility
City
Region
Status
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
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.
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