Hemay005, Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
DRUGHemay005
A PDE-4 inhibitor
Sponsors
Ganzhou Hemay Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EASI-75 | week 12 | Percentage of subjects reaching 75% or higher improvement from baseline |
Countries
China
Outcome results
None listed