This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)

A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Difamilast Ointment 1% in Children, Adolescents, and Adults With Mild to Moderate Atopic Dermatitis

This is a Phase 3 Double Blind multi-center study conducted at 40 investigational sites in United States to assess the efficacy and safety of Difamilast Ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Difamilast; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Stephanie Magajna, MS; Phone Number: 208-719-7876; Email: smagajna@therapeuticsinc.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • AllerVie Health
  • 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.
    • Lancaster, California, United States, 93534
      • Antelope Valley Clinical Trials
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Sherman Oaks, California, United States, 91403
      • Shahram Jacobs, MD Inc.
    • Thousand Oaks, California, United States, 91320
      • Clinical Trials Research Institute
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers
  • Florida
    • Brandon, Florida, United States, 33511
      • TrueBlue Clinical Research
    • Edgewater, Florida, United States, 32132
      • Accel Research - Edgewater Clinical Research Unit
    • North Miami Beach, Florida, United States, 33162
      • Tory Sullivan, Md Pa
    • Orlando, Florida, United States, 32829
      • Nona Pediatrics
    • Ormond Beach, Florida, United States, 32174
      • Accel Research - Ormond Clinical Research Unit
    • Saint Petersburg, Florida, United States, 33706
      • Olympian Clinical Research
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • DS Research
    • 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
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • DS Research
  • Louisiana
    • 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
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services, PLLC
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Bexley dermatology research
    • Boardman, Ohio, United States, 44512
      • Optima Research
    • Columbus, Ohio, United States, 43215
      • Remington-Davis, Inc.
  • Pennsylvania
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • PEAK Research, LLC
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research - Tennessee LLC
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Frisco, Texas, United States, 75034
      • North Texas Center for Clinical Research
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, Ltd, LLP
    • Sugar Land, Texas, United States, 77479
      • Houston Center for Clinical Research
  • 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
2. Subjects and/or their parent(s)/legal guardian(s) (if subject is under the legal age of consent) provide written informed consent in accordance with federal and/or local laws prior to the conduct of any study-related procedures.
3. Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria
4. Subjects who have had a diagnosis of AD for at least 6 months prior to Screening visit
5. Subjects who have AD involvement ≥5% to ≤40% of treatable Body Surface Area (BSA) excluding scalp
6. Subjects who have an AD Severity of mild (2) or moderate (3) as measured by the IGA of AD Severity score at screening and baseline visit

Important Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding or who plan to become pregnant during the study and through 90 days after the last dose of study drug
2. Subjects who have evidence of spontaneous clearance of AD between screening and baseline visits
3. Subjects who have a history of unstable AD as assessed by the Investigator. Unstable AD is defined as disease flares occurring within 4 weeks prior to baseline visit
4. Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected AD
5. Subject with greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits
6. Subjects who have a known history of alcohol abuse or illicit drugs within 6 months prior to screening

Etc.,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Difamilast Ointment; 1% Difamilast Ointment	Drug: Difamilast; Off-white ointment containing active ingredient, petrolatum and other ingredients
Placebo Comparator: Vehicle Controlled; Matching placebo	Drug: Placebo; Matching Difamilast (Study drug) ointment without active ingradient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of twice-daily topical application of Difamilast ointment 1% compared to vehicle control in subjects ≥2 years of age with mild to moderate AD	The proportion of subjects achieving success on the the 5-point Investigator Global Assessment (IGA) of AD Severity score at Day 29, and the success is defined as as a score of Clear (0) or Almost clear (1), with at least a 2-grade improvement from Baseline on the 5-point IGA of AD Severity score at Day 29	Baseline, Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD	The proportion of subjects achieving an IGA of AD Severity score of Clear (0) or Almost clear (1) at Day 29; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15	Baseline, Day 15, Day 22 and Day 29

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

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: MM36-301

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