This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)

Study Overview
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Brief Summary
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This is a Phase 3 Double Blind multi-center study conducted at 40 investigational sites in United States to assess the efficacy and safety of Difamilast Ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.

Official Title
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A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Difamilast Ointment 1% in Children, Adolescents, and Adults With Mild to Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Difamilast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Important Inclusion Criteria: Subjects who are male or female ≥2 years of age Subjects and/or their parent(s)/legal guardian(s) (if subject is under the legal age of consent) provide written informed consent in accordance with federal and/or local laws prior to the conduct of any study-related procedures. Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria Subjects who have had a diagnosis of AD for at least 6 months prior to Screening visit Subjects who have AD involvement ≥5% to ≤40% of treatable Body Surface Area (BSA) excluding scalp Subjects who have an AD Severity of mild (2) or moderate (3) as measured by the IGA of AD Severity score at screening and baseline visit Important Exclusion Criteria: Female subjects who are pregnant or breastfeeding or who plan to become pregnant during the study and through 90 days after the last dose of study drug Subjects who have evidence of spontaneous clearance of AD between screening and baseline visits Subjects who have a history of unstable AD as assessed by the Investigator. Unstable AD is defined as disease flares occurring within 4 weeks prior to baseline visit Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected AD Subject with greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits Subjects who have a known history of alcohol abuse or illicit drugs within 6 months prior to screening Etc.,

Ages Eligible for Study
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Minimum Age: 2 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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Difamilast Ointment<br>1% Difamilast Ointment | Drug: Difamilast<br>* Off-white ointment containing active ingredient, petrolatum and other ingredients<br>|
| Placebo Comparator: Vehicle Controlled<br>Matching placebo | Drug: Placebo<br>* Matching Difamilast (Study drug) ointment without active ingradient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of twice-daily topical application of Difamilast ointment 1% compared to vehicle control in subjects ≥2 years of age with mild to moderate AD | The proportion of subjects achieving success on the the 5-point Investigator Global Assessment (IGA) of AD Severity score at Day 29, and the success is defined as as a score of Clear (0) or Almost clear (1), with at least a 2-grade improvement from Baseline on the 5-point IGA of AD Severity score at Day 29 | Baseline, Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD | The proportion of subjects achieving an IGA of AD Severity score of Clear (0) or Almost clear (1) at Day 29; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15 | Baseline, Day 15, Day 22 and Day 29 |