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Completed

NCT Number: NCT05769946

A Study of Hemay005 in Adult With 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.

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Key information

Conditions

Hemay005, Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hemay005

Drug

A PDE-4 inhibitor

Primary outcomes

  1. EASI-75

    Time frame: week 12

    Percentage of subjects reaching 75% or higher improvement from baseline

Sponsors and collaborators

Lead sponsor

Ganzhou Hemay Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2023
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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