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NCT Number: NCT05571943

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AllerVie Health, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Difamilast

Drug

Difamilast Ointment 1%

Primary outcomes

  1. The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug

    Time frame: 52 week study period

  2. Proportion of subjects who discontinue due to an AE over the study period

    Time frame: 52-week study period

Sponsors and collaborators

Lead sponsor

Acrotech Biopharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2022
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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