A Study of Hemay005 in Adult With Atopic Dermatitis

NCT05769946 | Completed Phase 2

• 1 other identifier: HM005AD2S01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemay005, Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• EASI-75

  Percentage of subjects reaching 75% or higher improvement from baseline

  week 12

Study Arms (3)

placebo

PLACEBO COMPARATOR

Atopic dermatitis patients treated with placebo for 12 week.

Drug: Hemay005

Hemay005 60mg

EXPERIMENTAL

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

Drug: Hemay005

Hemay006 75mg

EXPERIMENTAL

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

Drug: Hemay005

Interventions

Hemay005 DRUG

A PDE-4 inhibitor

Hemay005 60mg; Hemay006 75mg; placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign the informed consent form for this study;
• 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.

You may not qualify if:

• 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;
• When investgater believe that any condition could lead to unnecessary risks for patients participating in the study.

Sponsors & Collaborators

• Ganzhou Hemay Pharmaceutical Co., Ltd: lead

Study Sites (1)

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Hemay005

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: November 24, 2022
• Primary Completion: January 24, 2024
• Study Completion: February 21, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)