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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Primary Sjögren's Syndrome

In brief

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).

Key facts

Study ID

NCT07727486

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

240

Starts

2026-08-01

Expected to finish

2029-03-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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