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NCT07727486
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

ICP-488 Tablets

Specified dose on specified days

DRUG

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