ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
Recruiting · NCT06775860 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
ICP-332 Placebo TabletsICP-332 Tablets
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
60 locations listed.
- 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 Municipality, China
- Peking University First Hospital - Beijing, Beijing Municipality, China
- Capital Medical University Affiliated Beijing Friendship Hospital - Beijing, Beijing Municipality, China
- Peking University Third Hospital - Beijing, Beijing Municipality, China
- Beijing Tongren Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- Beijing Tsinghua Changgung Hospital - Beijing, Beijing Municipality, China
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, Chongqing Municipality, China
- Chongqing Traditional Chinese Medicine Hospital - Chongqing, Chongqing Municipality, 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
- 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
- Sanmenxia Central Hospital - Sanmenxia, Henan, China
- Henan Provincial People's Hospital - Zhengzhou, Henan, China
- Jingzhou Central Hospital - Jingzhou, Hubei, China
- Wuhan Central Hospital - Wuhan, Hubei, China
- Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) - Wuhan, Hubei, China
- Central South University Xiangya Hospital - Changsha, Hunan, China
- The Second Xiangya Hospital of Central South University - Changsha, Hunan, China
- The Affiliated Hospital of Inner Mongolia Medical University - Hohhot, Inner Mongolia, China
- Changzhou First People's Hospital - Changzhou, Jiangsu, 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
- 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
- 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
- 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
- Shandong Provincial Dermatosis Hospital - Jinan, Shandong, China
- Jining First People's Hospital - Jining, Shandong, China
- The Affiliated Hospital of Qingdao University - Qingdao, Shandong, China
- Shanghai Tenth People's Hospital - Shanghai, Shanghai Municipality, China
- Shanghai First People's Hospital - Shanghai, Shanghai Municipality, China
- Shanghai Skin Disease Hospital - Shanghai, Shanghai Municipality, 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 Municipality, China
- Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine - Tianjin, Tianjin Municipality, China
- The First Affiliated Hospital of Kunming Medical University - Kunming, Yunnan, China
- Hangzhou First People's Hospital - Hangzhou, Zhejiang, China
- The Second Affiliated Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- The Third People's Hospital of Hangzhou - Hangzhou, Zhejiang, China
- The First Affiliated Hospital of Ningbo University - Ningbo, Zhejiang, China
Showing 60 of 62 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →