A Study of Hemay005 in Adult With Atopic Dermatitis

• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05769946
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 13.2
• Patients Per Site Per Month: 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemay005, Atopic Dermatitis	Drug: Hemay005	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase II Study to Evaluate the Efficacy and Safety of Hemay005 Tablet in Adult With Moderate to Severe Atopic Dermatitis
• Actual Study Start Date: Nov 24, 2022
• Anticipated Primary Completion Date: Jul 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. EASI-75 [week 12]

   Percentage of subjects reaching 75% or higher improvement from baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050000

Sponsors and Collaborators

• Ganzhou Hemay Pharmaceutical Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ganzhou Hemay Pharmaceutical Co., Ltd
• ClinicalTrials.gov Identifier: NCT05769946
• Other Study ID Numbers: HM005AD2S01
• First Posted: Mar 15, 2023
• Last Update Posted: Mar 16, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Hemay005

Study Results

No Results Posted as of Mar 16, 2023