A Study of Hemay005 in Adult With Atopic Dermatitis

Ganzhou Hemay Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Hemay005, Atopic Dermatitis

Treatments: Drug: Hemay005

Study type: Interventional

Funder types: Industry

Identifiers

NCT05769946

HM005AD2S01

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Atopic dermatitis patients treated with placebo for 12 week.

Treatment:

Drug: Hemay005

Hemay005 60mg

Experimental group

Description:

Atopic dermatitis patients treated with Hemay005 60mg BID for 12 week.

Treatment:

Drug: Hemay005

Hemay006 75mg

Experimental group

Description:

Atopic dermatitis patients treated with Hemay005 75mg BID for 12 week.

Treatment:

Drug: Hemay005