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

Last updated: August 8, 2024
Sponsor: Acrotech Biopharma Inc.
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Allergy

Skin Infections/disorders

Treatment

Difamilast

Clinical Study ID

NCT05571943
MM36-302
  • Ages > 2
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ADdiagnostic 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 surfacearea (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 studyMEDI-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.

Exclusion

Important Exclusion Criteria:

  1. Subjects who have an AD flare (defined as rapid intensification of AD) within 28days prior to Screening or Baseline (except for those previously enrolled in StudyMEDI-MM36-301) or history of consistent requirement for high-potency topicalcorticosteroids to manage AD signs and symptoms.

  2. Subjects who have an active or acute skin infection (eg, herpes simplex, herpeszoster, 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 usinginvestigational drug

Study Design

Total Participants: 542
Treatment Group(s): 1
Primary Treatment: Difamilast
Phase: 3
Study Start date:
September 15, 2022
Estimated Completion Date:
July 31, 2024

Connect with a study center

  • AllerVie Health

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Elite Clinical Studies, LLC

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • NEA Baptist Clinic-Dermatology

    Jonesboro, Arkansas 72405
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California 94538
    United States

    Site Not Available

  • Southern CA Dermatology Skin and Laser

    Laguna Niguel, California 92677
    United States

    Site Not Available

  • Antelope Valley Clinical Trials

    Lancaster, California 93534
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Clinical Trials Research Institute

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Clarity Dermatology, LLC

    Castle Rock, Colorado 80109
    United States

    Site Not Available

  • IMMUNOe Research Centers

    Centennial, Colorado 80112
    United States

    Site Not Available

  • TrueBlue Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Annexus Dermatology & Aethestics

    DeLand, Florida 32720
    United States

    Site Not Available

  • Accel Research - Edgewater Clinical Research Unit

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Complete Health Research

    Edgewater, Florida 32132
    United States

    Active - Recruiting

  • Skin Care Research

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Kirsch Dermatology

    Naples, Florida 34102
    United States

    Site Not Available

  • Tory Sullivan, MD PA

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Nona Pediatrics

    Orlando, Florida 32829
    United States

    Site Not Available

  • Pure Skin Dermatology & Aesthetics

    Orlando, Florida 32819
    United States

    Site Not Available

  • Accel Research - Ormond Clinical Research Unit

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Complete Health Research

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Olympian Clinical Research

    Saint Petersburg, Florida 33706
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • DS Research

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • The Indiana Clinical Trials Center

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • South Bend Clinic

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Options Research Group, LLC

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • Meridian Clinical Research

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • DS Research

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Avant Research Associates, LLC

    Crowley, Louisiana 70526
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • DermAssociates, LLC

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Metro Boston Clinical Partners

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Oakland Hills Dermatology, PC

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • Michigan Dermatology Institute

    Waterford, Michigan 48328
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • Cleaver Dermatology

    Kirksville, Missouri 63501
    United States

    Site Not Available

  • Vivida Dermatology

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Forest Hills Dermatology Group

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Optima Research

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Optimed Research

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Remington-Davis, Inc.

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania 19462
    United States

    Site Not Available

  • Peak Research, LLC

    Upper Saint Clair, Pennsylvania 15241
    United States

    Site Not Available

  • Palmetto Clinical Trial Services, LLC

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Coastal Pediatric Research

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • International Clinical Research - Tennessee, LLC

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Arlington Research Center, Inc.

    Arlington, Texas 76011
    United States

    Site Not Available

  • Derm Research

    Austin, Texas 78759
    United States

    Site Not Available

  • J&S Studies

    College Station, Texas 77845
    United States

    Site Not Available

  • North Texas Center for Clinical Research

    Frisco, Texas 75034
    United States

    Site Not Available

  • Center for Clinical Studies, Ltd, LLP

    Houston, Texas 77004
    United States

    Site Not Available

  • Research Your Health

    Plano, Texas 75093
    United States

    Site Not Available

  • Houston Center for Clinical Research

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

  • Premier Clinical Research, LLC

    Spokane, Washington 99202
    United States

    Site Not Available

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