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A Study of Hemay005 in Adult With Atopic Dermatitis

Primary Purpose

Hemay005, Atopic Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hemay005
Sponsored by
Ganzhou Hemay Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemay005, Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

Hemay005 60mg

Hemay006 75mg

Arm Description

Atopic dermatitis patients treated with placebo for 12 week.

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

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

Outcomes

Primary Outcome Measures

EASI-75
Percentage of subjects reaching 75% or higher improvement from baseline

Secondary Outcome Measures

Full Information

First Posted
March 3, 2023
Last Updated
March 14, 2023
Sponsor
Ganzhou Hemay Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05769946
Brief Title
A Study of Hemay005 in Adult With Atopic Dermatitis
Official Title
A Phase II Study to Evaluate the Efficacy and Safety of Hemay005 Tablet in Adult With Moderate to Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ganzhou Hemay Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemay005, Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Atopic dermatitis patients treated with placebo for 12 week.
Arm Title
Hemay005 60mg
Arm Type
Experimental
Arm Description
Atopic dermatitis patients treated with Hemay005 60mg BID for 12 week.
Arm Title
Hemay006 75mg
Arm Type
Experimental
Arm Description
Atopic dermatitis patients treated with Hemay005 75mg BID for 12 week.
Intervention Type
Drug
Intervention Name(s)
Hemay005
Intervention Description
A PDE-4 inhibitor
Primary Outcome Measure Information:
Title
EASI-75
Description
Percentage of subjects reaching 75% or higher improvement from baseline
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoqiang Zhang, MD
Phone
85917410
Ext
860311
Email
zgq810328@sina.com
First Name & Middle Initial & Last Name & Degree
Guoqiang Zhang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Hemay005 in Adult With Atopic Dermatitis

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