A Study of Hemay005 in Adult With Atopic Dermatitis

NCT ID: NCT05769946

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-24
• Study Completion Date: 2024-02-21

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.

Conditions

Hemay005, Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

Atopic dermatitis patients treated with placebo for 12 week.

Group Type: PLACEBO_COMPARATOR

Hemay005

Intervention Type: DRUG

A PDE-4 inhibitor

Hemay005 60mg

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

Group Type: EXPERIMENTAL

Hemay005

Intervention Type: DRUG

A PDE-4 inhibitor

Hemay006 75mg

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

Group Type: EXPERIMENTAL

Hemay005

Intervention Type: DRUG

A PDE-4 inhibitor

Interventions

Hemay005

A PDE-4 inhibitor

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ganzhou Hemay Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

HM005AD2S01

Identifier Type: -

Identifier Source: org_study_id