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This is a Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients with Mild-to-Moderate Atopic Dermatitis.
It will consist of phase II and phase III parts, phase II will be a dose-ranging part and phase III will be a pivotal study part.
This study will evaluate the topical SHR0302 ointment, a JAK (Janus Kinase) inhibitor, in atopic dermatitis patients. The EASI (Eczema Area and Severity Index), IGA (immunoglobulin A), SCORAD (Scoring of Atopic Dermatitis),DLQI (Dermatology Life Quality Index)and NRS (Numeric Rating Score) will be applied to assesses to the efficacy, and other safety measurements will be also collected within the whole study duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: SHR0302 Ointment Dose#1 | Active Comparator | Drug: SHR0302 Ointment Twice a day (BID) |
|
| Active Comparator: SHR0302 Ointment Dose#2 | Active Comparator | Drug: SHR0302 Ointment Twice a day (BID) |
|
| Active Comparator: SHR0302 Ointment Dose#3 | Active Comparator | Drug: SHR0302 Ointment Twice a day (BID) |
|
| Placebo Comparator: Placebo | Placebo Comparator | Drug: Vehicle Twice a day (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 Ointment | Drug | SHR0302 Ointment Twice a day (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8 | The percentage of subjects achieving the Investigator's Global Assessment(IGA)of clear (0) or almost clear (1) with a ≥2 points improvement from baseline at Week 8 | 8 weeks |
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Inclusion Criteria:
Male or female subject at least at ≥18 and ≤75years of age at time of informed consent.
Have mild-to- moderate AD (Atopic Dermatitis), as determined by all of the following:
Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study
All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from signing of informed consent, throughout the duration of the study, and for 28 days after last dose of study medication.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhong Cheng | Reistone Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | China | |||
| Beijing Friendship Hospital, Capital Medical University |
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| SHR0302 Ointment | Drug | SHR0302 Ointment Twice a day (BID) |
|
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| SHR0302 Ointment | Drug | SHR0302 Ointment Twice a day (BID) |
|
|
| Vehicle | Drug | Twice a day (BID) |
|
|
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Beijing Hospital | Beijing | Beijing Municipality | China |
| Chongqing Traditional Chinese Medicine Hospital | Chongqing | Chongqing Municipality | China |
| The First Hospital Affiliated to AMU (Southwest Hospital) | Chongqing | Chongqing Municipality | China |
| Xinqiao Hospital of AMU | Chongqing | Chongqing Municipality | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| The First Affiliated Hospital Sun Yat-sen University | Guangzhou | Guangdong | China |
| Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | China |
| Nanyang first people's Hospital | Nanyang | Henan | China |
| Wuhan NO.1 Hospital | Wuhan | Hubei | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Second People's Hospital of Wuxi | Wuxi | Jiangsu | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| Jiangxi Provincial Hospital of Dermatology | Nanchang | Jiangxi | China |
| The Second Hospital of Jilin University | Changchun | Jilin | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | 200071 | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | 300120 | China |
| SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310020 | China |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
| Hangzhou Third People's Hospital | Hangzhou | Zhejiang | China |
| Hwa Mei Hospital | Ningbo | Zhejiang | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| The Third Xiangya Hospital of Central South University | Changsha | 410013 | China |
| Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University | Guangzhou | 51000 | China |
| Zhejiang province People's Hospital | Hangzhou | 310014 | China |
| Huashan Hospital Fudan University | Shanghai | China |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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