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A Study to Evaluate the Efficacy and Safety of ICP-488 in Participants With Primary Sjögren's Syndrome
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
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).
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)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-08
Completion Date
2029-03
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
ICP-488 Tablets
Specified dose on specified days
ICP-488 Placebo
Specified dose on specified days
Locations (22)
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