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

Status: Recruiting
Location: See all (70) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tongren Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Tsinghua Changgung Hospital
NOT_YET_RECRUITING
Beijing
Capital Medical University Affiliated Beijing Chaoyang Hospital
RECRUITING
Beijing
Capital Medical University Affiliated Beijing Friendship Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Central South University Xiangya Hospital
NOT_YET_RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Changzhou First People's Hospital
RECRUITING
Changzhou
Affiliated Hospital of Chengde Medical University
NOT_YET_RECRUITING
Chengde
Chengdu Second People's Hospital
RECRUITING
Chengdu
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Chongqing Traditional Chinese Medicine Hospital
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
The Affiliated Union Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
The First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
The First Affiliated Hospital of Gannan Medical University
RECRUITING
Ganzhou
Dermatology Hospital of Southern Medical University
RECRUITING
Guangzhou
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Zhongshan University Sun Yat-sen Memorial Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital of Hainan Medical University
NOT_YET_RECRUITING
Haikou
The People's Hospital of Haikou City
NOT_YET_RECRUITING
Haikou
Affiliated Hospital of Hebei University of Engineering
RECRUITING
Handan
The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Third People's Hospital of Hangzhou
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Jiaxing First Hospital
NOT_YET_RECRUITING
Jiaxing
Jiaxing Second Hospital
NOT_YET_RECRUITING
Jiaxing
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong Provincial Dermatosis Hospital
NOT_YET_RECRUITING
Jinan
Jingzhou Central Hospital
NOT_YET_RECRUITING
Jingzhou
Jining First People's Hospital
RECRUITING
Jining
Affiliated Hospital of Jiujiang University
RECRUITING
Jiujiang
The First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
Liuzhou People's Hospital
RECRUITING
Liuzhou
The Second Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
Meihekou Central Hospital
NOT_YET_RECRUITING
Meihekou
Jiangxi Provincial Dermatology Hospital
NOT_YET_RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Sir Run Run Hospital, Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Nanyang First People's Hospital
NOT_YET_RECRUITING
Nanyang
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Sanmenxia Central Hospital
RECRUITING
Sanmenxia
Shanghai First People's Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Skin Disease Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Tenth People's Hospital
NOT_YET_RECRUITING
Shanghai
Yuebei People's Hospital
RECRUITING
Shaoguan
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine (Shenyang Seventh People's Hospital)
NOT_YET_RECRUITING
Shenyang
Zhongyi Northeast International Hospital Co., Ltd.
NOT_YET_RECRUITING
Shenyang
Shenzhen Second People's Hospital
RECRUITING
Shenzhen
Second Affiliated Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Taiyuan Central Hospital
NOT_YET_RECRUITING
Taiyuan
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
NOT_YET_RECRUITING
Tianjin
General Hospital of Tianjin Medical University
NOT_YET_RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Wuhan Central Hospital
NOT_YET_RECRUITING
Wuhan
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
NOT_YET_RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
The Second Affiliated Hospital of Wannan Medical College
RECRUITING
Wuhu
Shaanxi Provincial People's Hospital
RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The Second Affiliated Hospital of Xiamen Medical College
NOT_YET_RECRUITING
Xiamen
Yancheng First People's Hospital
NOT_YET_RECRUITING
Yancheng
General Hospital of Ningxia Medical University
NOT_YET_RECRUITING
Yinchuan
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Yiwu
Yuncheng Central Hospital
NOT_YET_RECRUITING
Yuncheng
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Pengcheng Lei
pengcheng.lei@innocarepharma.com
+86 18501252185
Time Frame
Start Date: 2024-11-14
Estimated Completion Date: 2026-12-25
Participants
Target number of participants: 552
Treatments
Experimental: ICP-332
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.

This content was sourced from clinicaltrials.gov

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