A Study of Hemay005 in Adult With Atopic Dermatitis

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

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.

Study Overview

• Status: Completed
• Conditions: Hemay005, Atopic Dermatitis
• Intervention / Treatment: Drug: Hemay005

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • First Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Atopic dermatitis patients treated with placebo for 12 week.	Drug: Hemay005; A PDE-4 inhibitor
Experimental: Hemay005 60mg; Atopic dermatitis patients treated with Hemay005 60mg BID for 12 week.	Drug: Hemay005; A PDE-4 inhibitor
Experimental: Hemay006 75mg; Atopic dermatitis patients treated with Hemay005 75mg BID for 12 week.	Drug: Hemay005; A PDE-4 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EASI-75	Percentage of subjects reaching 75% or higher improvement from baseline	week 12

Collaborators and Investigators

• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Hemay005
• Other Study ID Numbers: HM005AD2S01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No