NCT05769946CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 1 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 3 Mar 2023
- Start date
- 24 Nov 2022
- Primary completion date
- 24 Jan 2024
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05769946
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 79
- From 24 Nov 2022 to the primary completion date, 24 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Allergic to the drug or its preparation；
- When investgater believe that any condition could lead to unnecessary risks for patients participating in the study.
Other
- A medical history unsuitable for participation in a clinical study；
- Pregnant or lactating women；
- Any clinically significant abnormality in 12-lead ECG at screening that was judged by the investigator as unsuitable for inclusion；
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.