SafetyPhase 2NCT07877155
To Evaluate the Safety and Efficacy of Hemay5394 in Patients With Mild to Moderate Atopic Dermatitis
A Phase 2 study testing Hemay5394 group in people with Safety and Efficiency, run by Hemay Pharmaceutical PTY. LTD. at 1 site in Australia.
Trial summary
Evaluate the safety and efficacy of Hemay5394 in patients with mild to moderate atopic dermatitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Safety, Efficiency
- What is being tested?
- Hemay5394 group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Aged ≥18 years and ≤75 years, male or female, at the time of signing the ICF;
- Meeting the Hanifin \& Rajka diagnostic criteria for atopic dermatitis (AD), with a documented history of AD of at least 6 months prior to screening (participants with prior diagnoses described as "eczema", "dermatitis" or similar terms, who have a disease history meeting the inclusion criteria and can provide corresponding medical records, such as inpatient or outpatient charts, and are judged by the investigator to have AD at screening, may be enrolled);
- Having a vIGA-AD score of 2 or 3 at the baseline visit;
- Having an EASI score between 5 and 21 (inclusive) at baseline;
- Having AD-affected lesion areas (excluding lesions on the scalp, palms, and soles, but including facial lesions) involving 5%-25% of body surface area (BSA) at the baseline visit, and the lesion sites are suitable for topical treatment;
- Female participants of childbearing potential and male participants who have not undergone vasectomy must agree to use effective contraception during the study period and for 3 months after the last dose, and must fully understand the study content;
- Voluntarily participation in the study with signed informed consent form.
Who cannot join
- Presence of infection in the AD lesion area requiring topical or systemic anti-infective therapy, or requiring very potent or potent topical corticosteroids or systemic corticosteroids to control AD disease activity;
- Presence of other active inflammatory skin diseases (e.g., psoriasis, seborrheic dermatitis, lupus, etc.) that, in the investigator's judgment, would interfere with the assessment of response to study drugs;
- Presence of scarring, tattoos, or hyperpigmentation in the AD lesion area that, in the investigator's judgment, would interfere with the assessment of response to study drugs;
- Presence of systemic or local active infection within 14 days prior to randomization;
- At screening, laboratory tests showing ALT or AST >2 × the upper limit of normal, or severe renal insufficiency (creatinine clearance <30 mL/min calculated using the Cockcroft-Gault formula; one repeat test is allowed, and participants who still fail to meet the inclusion criteria after repeat testing will be excluded);
- Unwillingness to limit excessive ultraviolet exposure (e.g., sunbathing and/or use of tanning devices) during the study;
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- History of tuberculosis or active tuberculosis (presence of signs or symptoms suggestive of active tuberculosis as judged by the investigator at screening); Note: Participants with a prior history of tuberculosis may be screened if, in the investigator's assessment, the condition has been cured for at least 3 years prior to randomization.
- Prior or suspected human immunodeficiency virus (HIV) infection, or positive HIV antibody at screening; or positive hepatitis B surface antigen (HbsAg); or positive hepatitis B core antibody (HBcAb) with hepatitis B virus deoxyribonucleic acid (HBV-DNA) above the upper limit of normal; or positive hepatitis C virus (HCV) antibody with HCV RNA above the upper limit of normal; or positive treponemal-specific antibody test (participants with a positive treponemal-specific antibody test may be enrolled if the non-treponemal antibody test is negative and, based on clinical judgment, the infection is considered inactive);
- Receipt of the following treatments within the specified time periods prior to baseline evaluation:
- Treatment with biologic agents (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer);
- Use of JAK inhibitors, systemic corticosteroids and/or immunosuppressants, or undergoing sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.), or systemic use of traditional Chinese medicines or natural medicines for the purpose of treating AD within 4 weeks;
- Systemic or topical use of PDE4 inhibitors within 4 weeks, or prior history of inadequate response or intolerance to PDE4 inhibitors;
- Use of systemic anti-infective agents (including oral and intravenous administration), or topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, or topical traditional Chinese medicines or natural medicines for the purpose of treating AD, or other topical therapies for AD [e.g., zinc oxide oil (paste), Heidouliuyou Ruangao, doxepin cream, etc.] within 2 weeks;
- Use of sedating antihistamines or other over-the-counter drugs containing sedating antihistamines, or topical products containing urea within 1 week prior to randomization;
- Use of non-sedating antihistamines at non-stable doses within 2 weeks or 5 half-lives (whichever is longer) prior to randomization;
- Use of topical antimicrobial agents within 1 week;
- Presence of severe central nervous system, cardiovascular, respiratory, hepatic, renal, gastrointestinal, urogenital, endocrine, or hematological disorders that, in the investigator's judgment, may confound study results or affect participant safety;
- Diagnosis of severe psychiatric disorders or other conditions affecting study compliance that may interfere with the conduct of the clinical study;
- History of malignancy (except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma of the skin, and cervical carcinoma in situ, with documented cure);
- Prior severe hypersensitivity to topical dermatological preparations (including angioedema, anaphylaxis, etc.), or known allergy to any excipient of Hemay5394;
- History of long-term drug abuse or chronic alcohol abuse within 6 months prior to screening;
- Female participants who are suspected of being pregnant, are currently pregnant, are breastfeeding, or plan to become pregnant during the study;
- Participants who are scheduled to undergo inpatient surgery or require surgical intervention during the participation in the study;
- Participation in another drug/device clinical study and use of the trial drug/device within 3 months or 5 half-lives (whichever is longer) prior to randomization;
- Any other conditions that, in the investigator's judgment, make the participant unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Innovate Clinical Research
Waitara, New South Wales
McGirr, Dr, +61 2 9159 3838, info@innovateclinical.com.au
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 2 Clinical Study to Evaluate the Safety and Efficacy of Hemay5394 in Participants With Mild to Moderate Atopic Dermatitis
Evaluate the safety and efficacy of Hemay5394 in patients with mild to moderate atopic dermatitis
- Conditions
- Safety, Efficiency
- Being tested
- Hemay5394 group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay5394 groupDrug
investigational product，Topical administration, twice daily
Control groupDrug
Compared with the experimental group，Topical administration, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Hemay5394 group | Experimental | Not described Receives: Drug: Hemay5394 group |
| Control group | Active comparator | Not described Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving Eczema Area and Severity Index (EASI)-75
Measured: Week 4
Secondary outcomes (6)
Proportion of participants with success in the Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)
Measured: Week1,Week2, Week3, Week4, Week6, Week8, and Week9,
Proportion of participants with a ≥4-point reduction from baseline in the weekly average of the Worst Itch Numeric Rating Scale (WI-NRS) score
Measured: Week1,Week2, Week3, Week4, Week6, Week8, and Week9,
Percentage of participants achieving EASI-50
Measured: Week1, Week2, Week3, Week4, Week6, Week8, and Week9
Percentage of participants achieving EASI-75
Measured: Week1, Week2, Week3, Week4,Week6, Week8, and Week9
Percentage of participants achieving EASI-90
Measured: Week1, Week2, Week3, Week4,Week6, Week8, and Week9
Adverse events
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Measured: through study completion, an average of 9 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion3 Nov 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemay Pharmaceutical PTY. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877155
- Sponsor's protocol ID
- HM5394AD2S02
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 2 Clinical Study to Evaluate the Safety and Efficacy of Hemay5394 in Participants With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07877155
- Acronym / sponsor ID
- HM5394AD2S02
- Conditions
- Safety, Efficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hemay Pharmaceutical PTY. LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 3 Nov 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Oct 2026 (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.
Evaluate the safety and efficacy of Hemay5394 in patients with mild to moderate atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemay5394 group | Experimental | Drug: Hemay5394 group |
| Control group | Active comparator | Drug: Control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years and ≤75 years, male or female, at the time of signing the ICF;
- Meeting the Hanifin \& Rajka diagnostic criteria for atopic dermatitis (AD), with a documented history of AD of at least 6 months prior to screening (participants with prior diagnoses described as "eczema", "dermatitis" or similar terms, who have a disease history meeting the inclusion criteria and can provide corresponding medical records, such as inpatient or outpatient charts, and are judged by the investigator to have AD at screening, may be enrolled);
- Having a vIGA-AD score of 2 or 3 at the baseline visit;
- Having an EASI score between 5 and 21 (inclusive) at baseline;
- Having AD-affected lesion areas (excluding lesions on the scalp, palms, and soles, but including facial lesions) involving 5%-25% of body surface area (BSA) at the baseline visit, and the lesion sites are suitable for topical treatment;
Key exclusion criteria (25 listed)
- Presence of infection in the AD lesion area requiring topical or systemic anti-infective therapy, or requiring very potent or potent topical corticosteroids or systemic corticosteroids to control AD disease activity;
- Presence of other active inflammatory skin diseases (e.g., psoriasis, seborrheic dermatitis, lupus, etc.) that, in the investigator's judgment, would interfere with the assessment of response to study drugs;
- Presence of scarring, tattoos, or hyperpigmentation in the AD lesion area that, in the investigator's judgment, would interfere with the assessment of response to study drugs;
- Presence of systemic or local active infection within 14 days prior to randomization;
- At screening, laboratory tests showing ALT or AST >2 × the upper limit of normal, or severe renal insufficiency (creatinine clearance <30 mL/min calculated using the Cockcroft-Gault formula; one repeat test is allowed, and participants who still fail to meet the inclusion criteria after repeat testing will be excluded);
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 |
|---|---|---|
| Hemay5394 groupinvestigational product，Topical administration, twice daily | Drug | Hemay5394 group |
| Control groupCompared with the experimental group，Topical administration, twice daily | Drug | Control group |
Primary outcome
Proportion of participants achieving Eczema Area and Severity Index (EASI)-75
Time frame: Week 4
6 secondary outcomes
Proportion of participants with success in the Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)
Time frame: Week1,Week2, Week3, Week4, Week6, Week8, and Week9,
Proportion of participants with a ≥4-point reduction from baseline in the weekly average of the Worst Itch Numeric Rating Scale (WI-NRS) score
Time frame: Week1,Week2, Week3, Week4, Week6, Week8, and Week9,
Percentage of participants achieving EASI-50
Time frame: Week1, Week2, Week3, Week4, Week6, Week8, and Week9
Percentage of participants achieving EASI-75
Time frame: Week1, Week2, Week3, Week4,Week6, Week8, and Week9
Percentage of participants achieving EASI-90
Time frame: Week1, Week2, Week3, Week4,Week6, Week8, and Week9
Adverse events
Time frame: through study completion, an average of 9 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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.
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 Hemay5394 group in people with Safety and Efficiency, run by Hemay Pharmaceutical PTY. LTD. at 1 site in Australia.
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 7 inclusion and 25 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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 Australia. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zimeng Wang (022-24929667, wangzimeng@hemay.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving Eczema Area and Severity Index (EASI)-75 (time frame: Week 4). 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 16 Oct 2026.