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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Difamilast

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • AllerVie Health
    • Birmingham, Alabama, United States, 35205
      • Qualmedica Research, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies, LLC
  • Arkansas
    • Jonesboro, Arkansas, United States, 72405
      • NEA Baptist Clinic-Dermatology
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fremont, California, United States, 94538
      • Center For Dermatology Clinical Research, Inc.
    • Laguna Niguel, California, United States, 92677
      • Southern CA Dermatology Skin and Laser
    • Lancaster, California, United States, 93534
      • Antelope Valley Clinical Trials
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Thousand Oaks, California, United States, 91320
      • Clinical Trials Research Institute
  • Colorado
    • Castle Rock, Colorado, United States, 80109
      • Clarity Dermatology, LLC
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers
  • Florida
    • Brandon, Florida, United States, 33511
      • TrueBlue Clinical Research
    • DeLand, Florida, United States, 32720
      • Annexus Dermatology & Aethestics
    • Edgewater, Florida, United States, 32132
      • Accel Research - Edgewater Clinical Research Unit
    • Hollywood, Florida, United States, 33021
      • Skin Care Research
    • Naples, Florida, United States, 34102
      • Kirsch Dermatology
    • North Miami Beach, Florida, United States, 33162
      • Tory Sullivan, Md Pa
    • Orlando, Florida, United States, 32829
      • Nona Pediatrics
    • Orlando, Florida, United States, 32819
      • Pure Skin Dermatology & Aesthetics
    • Ormond Beach, Florida, United States, 32174
      • Accel Research - Ormond Clinical Research Unit
    • Saint Petersburg, Florida, United States, 33706
      • Olympian Clinical Research
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • DS Research
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research, LLC
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
    • West Lafayette, Indiana, United States, 47906
      • Options Research Group, Llc
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Meridian Clinical Research
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Qualmedica Research, LLC
    • Louisville, Kentucky, United States, 40241
      • DS Research
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management, LLC
    • Crowley, Louisiana, United States, 70526
      • Avant Research Associates, LLC
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management, LLC
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates, LLC
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology, PC
    • Waterford, Michigan, United States, 48328
      • Michigan Dermatology Institute
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Missouri
    • Kirksville, Missouri, United States, 63501
      • Cleaver Dermatology
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Vivida Dermatology
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Bexley dermatology research
    • Boardman, Ohio, United States, 44512
      • Optima Research
    • Columbus, Ohio, United States, 43215
      • Remington-Davis, Inc.
    • Columbus, Ohio, United States, 43235
      • Optimed Research
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Dermatology Associates of Plymouth Meeting
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • PEAK Research, LLC
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Palmetto Clinical Trial Services, LLC
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research - Tennessee, LLC
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Austin, Texas, United States, 78759
      • Derm Research
    • College Station, Texas, United States, 77845
      • J&S Studies
    • Frisco, Texas, United States, 75034
      • North Texas Center for Clinical Research
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, Ltd, LLP
    • Plano, Texas, United States, 75093
      • Research Your Health
    • Sugar Land, Texas, United States, 77479
      • Houston Center for Clinical Research
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Important Inclusion Criteria:

1. Subjects who are male or female ≥2 years of age at Screening (Visit 1).
2. Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria
3. Subjects who have had a diagnosis of AD for at least 3 months prior to Screening .
4. 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.
5. 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:

1. 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.
2. Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD
3. Subjects with significant systemic or localized infection
4. Subjects with minimal/mild depression and suicidal ideation

5. Subjects using restricted medications, biologics and alternative therapies, or using investigational drug

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Acrotech Biopharma Inc.
• Investigators: Study Director: Uma S Atmuri, MPharm MS, Acrotech Biopharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: MM36-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No