Hemay005, Atopic DermatitisPhase 2NCT05769946
A Study of Hemay005 in Adult With Atopic Dermatitis
A Phase 2 study testing Hemay005 in people with Hemay005, Atopic Dermatitis, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemay005, Atopic Dermatitis
- What is being tested?
- Hemay005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2022to 21 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: A Phase II Study to Evaluate the Efficacy and Safety of Hemay005 Tablet in Adult With Moderate to Severe 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.
- Conditions
- Hemay005, Atopic Dermatitis
- Being tested
- Hemay005
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay005Drug
A PDE-4 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Atopic dermatitis patients treated with placebo for 12 week. Receives: Drug: Hemay005 |
| Hemay005 60mg | Experimental | Atopic dermatitis patients treated with Hemay005 60mg BID for 12 week. Receives: Drug: Hemay005 |
| Hemay006 75mg | Experimental | Atopic dermatitis patients treated with Hemay005 75mg BID for 12 week. Receives: Drug: Hemay005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI-75
Percentage of subjects reaching 75% or higher improvement from baseline
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start24 Nov 2022
- Primary completion24 Jan 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemay005, Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769946
- Sponsor's protocol ID
- HM005AD2S01
- Status last verified
- Feb 2024
- First submitted
- 3 Mar 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy and Safety of Hemay005 Tablet in Adult With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05769946
- Acronym / sponsor ID
- HM005AD2S01
- Conditions
- Hemay005, Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Hemay005Atopic dermatitis patients treated with placebo for 12 week. |
| Hemay005 60mg | Experimental | Drug: Hemay005Atopic dermatitis patients treated with Hemay005 60mg BID for 12 week. |
| Hemay006 75mg | Experimental | Drug: Hemay005Atopic dermatitis patients treated with Hemay005 75mg BID for 12 week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemay005A PDE-4 inhibitor | Drug | Hemay005 60mg, Hemay006 75mg, placebo |
Primary outcome
EASI-75
Time frame: week 12
Percentage of subjects reaching 75% or higher improvement from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemay005 in people with Hemay005, Atopic Dermatitis, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EASI-75 (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.