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Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
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 subjects with cutaneous lupus erythematosus (CLE).
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2026-03
Completion Date
2027-12
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
ICP-488 Tablets
Patients will receive ICP-488 orally as per the protocol
ICP-488 Tablets
Patients will receive ICP-488 orally as per the protocol
ICP-488 Placebo
Patients will receive ICP-488 Placebo orally as per the protocol.
Locations (26)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dongguan people's hospital
Dongguan, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
The First AffiliatedHospital of China Medical University
Shenyang, Liaoning, China
Jinan Central Hospital
Jinan, Shandong, China
Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Hangzhou Third people's Hospital
Hangzhou, Zhejiang, China