Atopic DermatitisPhase 2NCT04352595
A Phase Ⅱ Study of Hemay808 for Atopic Dermatitis Patients
A Phase 2 study testing Hemay808 in people with Atopic Dermatitis, run by Tianjin Hemay Pharmaceutical Co., Ltd at 2 sites in China.
Trial summary
Assess Hemay808 concentration of 1%/3%/7% for treatment of mild and moderate adult atopic dermatitis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Hemay808
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 2 sitesChina
- Study dates
- 24 Apr 2020to 2 Apr 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old and ≤65 years old, gender is not limited;
- It met the diagnostic criteria for atopic dermatitis (AD) of Hanifin\&Rajka, and the history of AD before screening was ≥6 months;
- The investigator's overall score (IGA) at the screening period/baseline visit was 2-3;
- The skin lesion area of atopic dermatitis (excluding scalp lesions) is 3%-20% of body surface area (BSA) and suitable for local treatment;
- During the study period and within 3 months after the last administration, fertile female subjects and male subjects who did not receive vasectomy were required to take effective contraceptive measures;
- Those who have full knowledge of the test, participate in the test voluntarily and sign the informed consent.
Who cannot join
- The lesion area of AD is infected and requires local or systematic treatment with anti-infective drugs, or external administration of strong or potent glucocorticoids (see annex 4) or systematic administration of glucocorticoids to control AD Useing of systemic glucocorticoids and/or immunosuppressants within 4 weeks; Or sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.); Or systematic use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis;
- The AD lesion area was marked, tattooed, or hyperpigmented, and was judged by the investigator to interfere with the evaluation of the response to the study's drug therapy;
- Previous use of systemic or local pde-4 inhibitors;
- Suffering from clinically significant active systemic infections;
- 2 times the normal upper limit of ALT or AST >, or the normal upper limit of Cr and > of renal function (study allowed 1 reexamination, excluded if still not meeting the inclusion requirements);
- Unwilling to limit their excessive uv exposure during the study period (e.g., sunbathing and/or tanning devices);
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- Received the following treatment in the limited time period prior to baseline evaluation:
- . Received biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives, whichever is greater;
- . Use of systemic glucocorticoids and/or immunosuppressants within 4 weeks; Or sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.); Or systematic use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis;
- . The following treatment was administered within 2 weeks: systemic anti-infective drugs (both oral and intravenous); Or local use of glucocorticoid or local use of calcineurin inhibitor; Local use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis; Or other topical drugs for the treatment of atopic dermatitis [zinc oxide oil (paste), black bean oil ointment, doxepin cream, etc.];
- . Local anti - microbial preparation was used within 1 week;
- Suffering from serious diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal system, urinary system, endocrine system or blood system, and the researcher believes that may confused result or affect the safety of the subjects;
- Suffering from a serious mental illness or other condition that affects research compliance and may interfere with the conduct of clinical trials;
- A history of malignant tumor;
- With a history of severe allergic reactions to skin topical preparations (including angioedema, allergic reactions, etc.) or known allergic reactions to Hemay808 accessories;
- Screening people who had a long history of drug abuse or alcohol abuse in the first 6 months;
- Female subjects who are suspected to be pregnant, lactating or preparing for pregnancy during the test;
- The subject plans to undergo surgery requiring hospitalization or surgery during his or her participation in the study;
- Those who participated in clinical studies of other drugs/devices and used experimental drugs/devices within the last 3 months of randomized enrollment;
- Other conditions made the researchers considered inappropriate for the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Dermotology hospital, Chinese academy of medical science
Nanjing, Jiangsu, 210042
Ningbo second hospital
Ningbo, Zhejiang, 315010
About this study
Official title: Assess Hemay808 Concentration of Different Dosage Regimen for Mild and Moderate Atopic Dermatitis Patients the Safety and Efficacy of Multicenter, Randomized, Blinded, Excipient Parallel-group Phase Ⅱ Clinical Study
Assess Hemay808 concentration of 1%/3%/7% for treatment of mild and moderate adult atopic dermatitis patients.
- Conditions
- Atopic Dermatitis
- Being tested
- Hemay808
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay808Drug
Hemay808 is a onitment of Hemay028, a small molecule PDE4 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| 1% Hemay808 | Experimental | Not described Receives: Drug: Hemay808 |
| 3% Hemay808 | Experimental | Not described Receives: Drug: Hemay808 |
| 7% Hemay808 | Experimental | Not described Receives: Drug: Hemay808 |
| vehicle | Placebo comparator | Not described Receives: Drug: Hemay808 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the EASI score relative to the baseline.
EASI Clinical Signs Severity Sum Score change from Baseline at Day 29
Measured: Day 29
Secondary outcomes (7)
The percentage of subjects achieving Investigator's Global Score (IGA) response which improvement ≥ 2 from baseline.
The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
Measured: Day 8, Day 15, Day 22, Day 28
The percentage of subjects achieving Investigator's Global Score (IGA) score 0-1.
The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
Measured: Day 8, Day 15, Day 22, Day 28
The change in the IGA score relative to the baseline.
Change From Baseline in the IGA Clinical Signs Severity Sum Score.
Measured: Day 8, Day 15, Day 22, Day 28
The percentage of subjects achieving EASI90, EASI75, EASI50.
EASI Clinical Signs Severity Sum Score ≥50%, 75%, 90% improvement from baseline.
Measured: Day 8, Day 15, Day 22, Day 28
Absolute change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS).
Range of 0 (No itch) to 10 (Worst imaginable itch)
Measured: Day 8, Day 15, Day 22, Day 28
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score.
The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality
Measured: Day 8, Day 15, Day 22, Day 28
The percentage of AD invoved BSA (body surface area) change From Baseline.
AD invoved body surface area.
Measured: Day 8, Day 15, Day 22, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start24 Apr 2020
- Primary completion28 Feb 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352595
- Sponsor's protocol ID
- HM808AD2S01
- Status last verified
- Feb 2024
- First submitted
- 20 Mar 2020
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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
- Assess Hemay808 Concentration of Different Dosage Regimen for Mild and Moderate Atopic Dermatitis Patients the Safety and Efficacy of Multicenter, Randomized, Blinded, Excipient Parallel-group Phase Ⅱ Clinical Study
- ClinicalTrials.gov ID
- NCT04352595
- Acronym / sponsor ID
- HM808AD2S01
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 20 Apr 2020 (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.
Assess Hemay808 concentration of 1%/3%/7% for treatment of mild and moderate adult atopic dermatitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1% Hemay808 | Experimental | Drug: Hemay808 |
| 3% Hemay808 | Experimental | Drug: Hemay808 |
| 7% Hemay808 | Experimental | Drug: Hemay808 |
| vehicle | Placebo comparator | Drug: Hemay808 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years old and ≤65 years old, gender is not limited;
- It met the diagnostic criteria for atopic dermatitis (AD) of Hanifin\&Rajka, and the history of AD before screening was ≥6 months;
- The investigator's overall score (IGA) at the screening period/baseline visit was 2-3;
- The skin lesion area of atopic dermatitis (excluding scalp lesions) is 3%-20% of body surface area (BSA) and suitable for local treatment;
- During the study period and within 3 months after the last administration, fertile female subjects and male subjects who did not receive vasectomy were required to take effective contraceptive measures;
Key exclusion criteria (20 listed)
- The lesion area of AD is infected and requires local or systematic treatment with anti-infective drugs, or external administration of strong or potent glucocorticoids (see annex 4) or systematic administration of glucocorticoids to control AD Useing of systemic glucocorticoids and/or immunosuppressants within 4 weeks; Or sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.); Or systematic use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis;
- The AD lesion area was marked, tattooed, or hyperpigmented, and was judged by the investigator to interfere with the evaluation of the response to the study's drug therapy;
- Previous use of systemic or local pde-4 inhibitors;
- Suffering from clinically significant active systemic infections;
- 2 times the normal upper limit of ALT or AST >, or the normal upper limit of Cr and > of renal function (study allowed 1 reexamination, excluded if still not meeting the inclusion requirements);
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 |
|---|---|---|
| Hemay808Hemay808 is a onitment of Hemay028, a small molecule PDE4 inhibitor. | Drug | 1% Hemay808, 3% Hemay808, 7% Hemay808, vehicle |
Primary outcome
The change in the EASI score relative to the baseline.
Time frame: Day 29
EASI Clinical Signs Severity Sum Score change from Baseline at Day 29
7 secondary outcomes
The percentage of subjects achieving Investigator's Global Score (IGA) response which improvement ≥ 2 from baseline.
Time frame: Day 8, Day 15, Day 22, Day 28
The percentage of subjects achieving Investigator's Global Score (IGA) score 0-1.
Time frame: Day 8, Day 15, Day 22, Day 28
The change in the IGA score relative to the baseline.
Time frame: Day 8, Day 15, Day 22, Day 28
The percentage of subjects achieving EASI90, EASI75, EASI50.
Time frame: Day 8, Day 15, Day 22, Day 28
Absolute change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS).
Time frame: Day 8, Day 15, Day 22, Day 28
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score.
Time frame: Day 8, Day 15, Day 22, Day 28
The percentage of AD invoved BSA (body surface area) change From Baseline.
Time frame: Day 8, Day 15, Day 22, Day 28
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
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemay808 in people with Atopic Dermatitis, run by Tianjin Hemay Pharmaceutical Co., Ltd at 2 sites 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 20 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 2 sites 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?
The change in the EASI score relative to the baseline. (time frame: Day 29). 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.