Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.

Detailed Description
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Part 1 (2 cohorts): Total 33 subjects Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo) Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo) Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo) Part 2 (3 treatment groups): Total 177 subjects Low dose of HY209gel: 59 subjects High dose of HY209gel: 59 subjects Placebo (Vehicle): 59 subjects Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the Safety Monitoring Committee(SMC) that will review all available safety data of the planned dose level within the timeline specified on SMC charter after all enrolled subjects of each cohort complete 2-week treatment and determine the escalation to the next dose to be safe. Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel, compared to placebo (vehicle) for 8-week treatment period.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)

Conditions
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Atopic Dermatitis, Atopic Dermatitis Eczema, Atopic Dermatitis of Scalp

Intervention / Treatment
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* Drug: HY209GEL Active
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female subjects aged 18 or older Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist at least 6 months ago from screening Subjects who have a minimum of 5% and a maximum of 30% of total body surface area (BSA) affected by AD at screening and baseline visits Subjects with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visit Subjects who can give written informed consent Key Exclusion Criteria: Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) or any consistent requirement for any potency topical corticosteroids Subjects who have topical treatment with corticosteroids within 2 weeks prior to baseline visit or other topical treatments of the AD area at screening (moisturizers/emollients are allowed) Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatments within 4 weeks prior to baseline visit Subjects who had dupilumab or any other biologics within 6 months prior to baseline visit Subjects who take any systemic anti-infective or antibiotic treatments within 1 week prior to baseline visit Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks prior to screening Subjects who have active malignancy or history of cancer in 5 years prior to screening, except for treated cautions basal cell carcinoma and in situ cervical cancer Subjects who have any other skin diseases that would affect the ability to assess the AD Subjects who are taking strong CYP3A4 inhibitor or any other concomitant drug that, in the opinion of the PI, may cause interference with the treatment Subjects who participated in another drug or device trial within 4 weeks prior to screening...etc

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PART 2 High-Dose<br>Active group selected for PART1 as a high-dose | Drug: HY209GEL Active<br>* Selected two among three doses (HY209GEL 0.5% or 1% or 2%) in PART1<br>|
| Active Comparator: PART 2 Low-Dose<br>Active group selected for PART1 as a Low-dose | Drug: HY209GEL Active<br>* Selected two among three doses (HY209GEL 0.5% or 1% or 2%) in PART1<br>|
| Placebo Comparator: PART 2 Placebo<br>Placebo group | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in Eczema Area and Severity Index (EASI) score | To achieve lower score means disease improvement . | at Week 8 |