ICP-332 in Subjects with Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: ICP-332 TabletsDrug: ICP-332 Placebo Tablets
- Registration Number
- NCT06775860
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 552
-
Male or female subjects between 18 and 75 years of age.
-
Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
-
Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
-
Subjects must meet the following criteria for disease activity:
- Eczema Area and Severity Index (EASI) score ≥ 16 ;
- (Body Surface Area )BSA affected by AD ≥ 10% ;
- (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;
- Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
-
Women of childbearing potential (WOCBP) and Men must agree
-
Women of childbearing potential (WOCBP) and Men must agree to contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- Pregnant or breastfeeding females.
- History of any clinically major diseases, with the exception of atopic dermatitis.
- Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICP-332 ICP-332 Tablets - Placebo ICP-332 Placebo Tablets -
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline 16 weeks Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline 16 weeks
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (70)
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Capital Medical University Affiliated Beijing Chaoyang Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Capital Medical University Affiliated Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing Traditional Chinese Medicine Hospital
🇨🇳Chongqing, Chongqing, China
The Affiliated Union Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The Second Affiliated Hospital of Xiamen Medical College
🇨🇳Xiamen, Fujian, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Zhongshan University Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Yuebei People's Hospital
🇨🇳Shaoguan, Guangdong, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi, China
The First Affiliated Hospital of Hainan Medical University
🇨🇳Haikou, Hainan, China
The People's Hospital of Haikou City
🇨🇳Haikou, Hainan, China
Affiliated Hospital of Chengde Medical University
🇨🇳Chengde, Hebei, China
Affiliated Hospital of Hebei University of Engineering
🇨🇳Handan, Hebei, China
Second Affiliated Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Nanyang First People's Hospital
🇨🇳Nanyang, Henan, China
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
🇨🇳Wuhan, Hubei, China
Central South University Xiangya Hospital
🇨🇳Changsha, Hunan, China
Sanmenxia Central Hospital
🇨🇳Sanmenxia, Henan, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Wuhan Central Hospital
🇨🇳Wuhan, Hubei, China
Changzhou First People's Hospital
🇨🇳Changzhou, Jiangsu, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Sir Run Run Hospital, Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Yancheng First People's Hospital
🇨🇳Yancheng, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University
🇨🇳Ganzhou, Jiangxi, China
Shandong Provincial Dermatosis Hospital
🇨🇳Jinan, Shandong, China
Jining First People's Hospital
🇨🇳Jining, Shandong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Affiliated Hospital of Jiujiang University
🇨🇳Jiujiang, Jiangxi, China
Jiangxi Provincial Dermatology Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Meihekou Central Hospital
🇨🇳Meihekou, Jilin, China
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）
🇨🇳Shenyang, Liaoning, China
Zhongyi Northeast International Hospital Co., Ltd.
🇨🇳Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
🇨🇳Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, Shanghai, China
Taiyuan Central Hospital
🇨🇳Taiyuan, Shanxi, China
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
🇨🇳Tianjin, Tianjin, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Yiwu, Zhejiang, China
Yuncheng Central Hospital
🇨🇳Yuncheng, Shanxi, China
Chengdu Second People's Hospital
🇨🇳Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
General Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The Third People's Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China
Jiaxing First Hospital
🇨🇳Jiaxing, Zhejiang, China
The First Affiliated Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China
Jiaxing Second Hospital
🇨🇳Jiaxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China