Atopic Dermatitis (Difamilast Study)

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