A Study of Hemay005 in Adult With Atopic Dermatitis

Phase 2

Completed

• Conditions: Hemay005, Atopic Dermatitis
• Interventions: Drug: Hemay005

• Registration Number: NCT05769946
• Lead Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-24
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-15
• Primary Completion: 2024-01-24
• Status Verified: 2024-02
• Study Completion: 2024-02-21
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemay005 60mg	Hemay005	Atopic dermatitis patients treated with Hemay005 60mg BID for 12 week.
placebo	Hemay005	Atopic dermatitis patients treated with placebo for 12 week.
Hemay006 75mg	Hemay005	Atopic dermatitis patients treated with Hemay005 75mg BID for 12 week.

Primary Outcome Measures

Name	Time	Method
EASI-75	week 12	Percentage of subjects reaching 75% or higher improvement from baseline

Trial Locations

Locations (1)

First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China