A Study of Hemay005 in Adult With Atopic Dermatitis

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd
• Treatments: Hemay005

Criteria

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.