A Study of Hemay005 in Adult With Atopic Dermatitis

Study Overview
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Brief Summary
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A multicenter, randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of Hemay005 tablet in the treatment of moderate to severe atopic dermatitis.

Official Title
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A Phase II Study to Evaluate the Efficacy and Safety of Hemay005 Tablet in Adult With Moderate to Severe Atopic Dermatitis

Conditions
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Hemay005, Atopic Dermatitis

Intervention / Treatment
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* Drug: Hemay005


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand and voluntarily sign the informed consent form for this study; 18-75 years old (including boundary value) , gender is not limited; Ability to adhere to follow-up schedules and other program requirements; According to Hanifin & Rajka diagnostic criteria of atopic dermatitis (AD) , the patients with AD history ≥6 months; At baseline, the severity of AD was moderate to severe: IGA score was 3 or more, and the area of involved skin lesion was 10% BSA or more; Participants were required to use contraception during the study period. Exclusion Criteria: A medical history unsuitable for participation in a clinical study； Pregnant or lactating women； Allergic to the drug or its preparation； Patients who had undergone major surgery within 6 months before screening or who were scheduled for major surgery during the trial period； Participants who had participated in any drug or device clinical trial within the previous 3 months were screened； Vaccination with live or attenuated vaccines is planned for the duration of the trial； Any drugs is taking that may affect the effectiveness evaluation; Any clinically significant abnormality in 12-lead ECG at screening that was judged by the investigator as unsuitable for inclusion； When investgater believe that any condition could lead to unnecessary risks for patients participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Atopic dermatitis patients treated with placebo for 12 week. | Drug: Hemay005<br>* A PDE-4 inhibitor<br>|
| Experimental: Hemay005 60mg<br>Atopic dermatitis patients treated with Hemay005 60mg BID for 12 week. | Drug: Hemay005<br>* A PDE-4 inhibitor<br>|
| Experimental: Hemay006 75mg<br>Atopic dermatitis patients treated with Hemay005 75mg BID for 12 week. | Drug: Hemay005<br>* A PDE-4 inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI-75 | Percentage of subjects reaching 75% or higher improvement from baseline | week 12 |