A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis

Study Overview
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Brief Summary
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This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.

Official Title
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A Multicenter, Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in the Treatment of 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


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 at Screening (Visit 1). 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 3 months prior to Screening . Subjects who have an IGA of mild or moderate AD Severity and treatable body surface area (BSA) ≥3%at Baseline if not previously enrolled in study MEDI-MM36-301 OR b. IGA ≤ 3, with no minimum BSA and completed through Week 4/EOT Visit 6 of the study MEDI-MM36-301. Subject is willing and able to comply with all study-related procedures, including, but not limited to, application of the study drug, and visit requirements. Important Exclusion Criteria: Subjects who have an AD flare (defined as rapid intensification of AD) within 28 days prior to Screening or Baseline (except for those previously enrolled in Study MEDI-MM36-301) or history of consistent requirement for high-potency topical corticosteroids to manage AD signs and symptoms. Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD Subjects with significant systemic or localized infection Subjects with minimal/mild depression and suicidal ideation Subjects using restricted medications, biologics and alternative therapies, or using investigational drug -

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Difamilast Ointment 1%<br>A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart) | Drug: Difamilast<br>* Difamilast Ointment 1%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug |  | 52 week study period | 
| Proportion of subjects who discontinue due to an AE over the study period |  | 52-week study period |