Pharmacodynamic Blood Characteristics of ICP-332 in Patients With Moderate to Severe Atopic Dermatitis
NCT ID: NCT05702268
Last Updated: 2023-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
75 participants
INTERVENTIONAL
2023-03-18
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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High-dose
40 mg ICP-332 tablet 3 tablets, once a day
ICP-332
Tablet, 40 mg
Low-dose
40 mg ICP-332 2 tablets + 1 placebo tablet once daily
ICP-332 Placebo
Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.
ICP-332
Tablet, 40 mg
Blank control
Placebo 3 tablets once daily
ICP-332 Placebo
Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.
Interventions
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ICP-332 Placebo
Tablets, in appearance, size, color, dosage form, packaging, instructions, labels and other aspects of the corresponding specifications of ICP-332.
ICP-332
Tablet, 40 mg
Eligibility Criteria
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Inclusion Criteria
2. A clinical diagnosis of atopic dermatitis or eczema was made at least 1 year prior to D1, and atopic dermatitis was identified at screening visit (according to Williams criteria).
3. During screening and baseline, were defined as meeting the moderate and severe AD criteria as assessed by the researchers.
4. Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) , or other medically unrecommended topical therapy.
5. Able and willing to use an additive free mild emollient twice a day for at least 7 days prior to baseline and for the duration of the study.
6. The serum pregnancy test of all female subjects at screening visit was negative, and the urine pregnancy test of all fertile female subjects at baseline visit was negative before first dosing.
7. Subjects must voluntarily sign and date informed consent prior to the commencement of any screening or study specific procedures.
8. Subject is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
9. Fertile women (WOCBP) menstruation must occur during the screening period and consent to use a supplementary screen contraceptive method in combination with a highly effective contraceptive method during the study period and for 90 days after the last use of the study drug .Male subjects must be willing not to donate sperm during this period.
Exclusion Criteria
2. Subjects who had an active skin disease or skin infection that required systemic treatment or would interfere with the proper assessment of AD.
3. Current or previous infection history, including a history of herpes; Known history of invasive infection; Chronic recurrent infection and/or active invasive infection. Known immunodeficiency syndrome; Subjects with tuberculosis; Non skin related active infection.
4. Active HBV, HCV or HIV, syphilis infection.
5. Potential medical diseases or problems, including but not limited to the following: clinically relevant or significant ECG abnormalities; History of moderate to severe congestive heart failure, recent cerebrovascular accident, myocardial infarction or coronary stent implantation, or uncontrolled hypertension; Have received organ transplantation; A history of gastrointestinal perforation, diverticulitis, or a significant increased risk of gastrointestinal perforation according to the investigator's judgment; Diseases that may interfere with drug absorption; Subjects suffering from any malignant tumor before screening.
6. Except for atopic dermatitis, he has any clinically significant disease history or other clinically significant systemic diseases.
7. Received the specified treatment plan within the specified time frame.
8. The time from the last use of powerful CYP3A inhibitor or inducer to the first trial medication is less than 5 clearance half-life, or it is planned to take powerful CYP3A inhibitor or inducer at the same time during this study.
9. Those with a history of drug or alcohol abuse in the 6 months prior to baseline visit (as determined by the investigator).
10. During the screening period before the first administration of the study drug (baseline visit), the abnormal laboratory values met at least one of the specified standards.
11. The investigator considers for any reason that the subject is not suitable for participation in the study to receive ICP-332.
18 Years
75 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Second Hospital of the Army Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Nanyang First People's Hospital
Nanyang, Henan, China
Shiyan City People's Hospital
Shiyan, Hubei, China
Wuhan University People's Hospital
Wuhan, Hubei, China
Changzhou First People's Hospital
Changzhou, Jiangsu, China
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Suining Central Hospital
Suining, Sichuan, China
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Jiaxing First Hospital
Jiaxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Zhonghong Xie
Role: primary
Linfeng Li
Role: primary
Chunlei Zhang
Role: primary
Rupeng Wang
Role: primary
Chao Ji
Role: primary
Yunsheng Liang
Role: primary
Wenlin Yang
Role: primary
Xinsuo Duan
Role: primary
Guoqiang Zhang
Role: primary
Rixin Chen
Role: primary
Zudong Meng
Role: primary
Tiechi Lei
Role: primary
Ruzhi Zhang
Role: primary
Hui Sun
Role: primary
Yumei Li
Role: primary
Li Zhang
Role: primary
Jie Zheng
Role: primary
Yangfeng Ding
Role: primary
Wenli Feng
Role: primary
Chunshui Yu
Role: primary
Litao Zhang
Role: primary
Danqi Deng
Role: primary
Hong Fang
Role: primary
Aie Xu
Role: primary
Xiaohua Tao
Role: primary
Wenhao Yin
Role: primary
Zhiming Li
Role: primary
Other Identifiers
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ICP-CL-00602
Identifier Type: -
Identifier Source: org_study_id
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