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

Ganzhou Hemay Pharmaceutical Co., Ltd1 site in 1 country79 target enrollmentNovember 24, 2022

ConditionsHemay005, Atopic Dermatitis

InterventionsHemay005

DrugsHemay005

Overview

Phase: Phase 2
Intervention: Hemay005
Conditions: Hemay005, Atopic Dermatitis
Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd
Enrollment: 79
Locations: 1
Primary Endpoint: EASI-75
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 24, 2022

End Date

February 21, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ganzhou Hemay Pharmaceutical Co., Ltd

Responsible Party

Sponsor

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.