Study Description
Brief Summary
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.
Condition or Disease
Atopic Dermatitis
Study Design
| Study Type: |
Interventional (Clinical Trial) |
| Estimated Enrollment: |
500 participants |
| Allocation: |
N/A |
| Intervention Model: |
Single Group Assignment |
| Masking: |
None (Open Label) |
| Primary Purpose: |
Treatment |
| Official Title: |
| 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 |
|
| Actual Study Start Date: |
September 15, 2022 |
| Estimated Primary Completion Date: |
March 2024 |
| Estimated Study Completion Date: |
June 2024 |
Eligibility Criteria
| Ages Eligible for Study: |
2 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: |
All |
| Accepts Healthy Volunteers: |
No |
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.
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
ADDITIONAL DETAILS
