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

NCT05608343 | Completed Phase 3 FDA Drug

• 1 other identifier: MM36-301
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 39

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD

  Baseline, Day 15, Day 22 and Day 29

Study Arms (2)

Difamilast Ointment

ACTIVE COMPARATOR

1% Difamilast Ointment

Drug: Difamilast

Vehicle Controlled

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Difamilast DRUG

Off-white ointment containing active ingredient, petrolatum and other ingredients

Difamilast Ointment

Placebo DRUG

Matching Difamilast (Study drug) ointment without active ingradient

Vehicle Controlled

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are male or female ≥2 years of age
• 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.
• 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 6 months prior to Screening visit
• Subjects who have AD involvement ≥5% to ≤40% of treatable Body Surface Area (BSA) excluding scalp
• 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

You may not qualify if:

• 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
• Subjects who have evidence of spontaneous clearance of AD between screening and baseline visits
• 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
• Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected AD
• Subject with greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits
• Subjects who have a known history of alcohol abuse or illicit drugs within 6 months prior to screening
• Etc.,

Sponsors & Collaborators

• Acrotech Biopharma Inc.: lead

Study Sites (39)

AllerVie Health

Birmingham, Alabama, 35244, United States

Location

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

Location

NEA Baptist Clinic-Dermatology

Jonesboro, Arkansas, 72405, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Shahram Jacobs, MD Inc.

Sherman Oaks, California, 91403, United States

Location

Clinical Trials Research Institute

Thousand Oaks, California, 91320, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

TrueBlue Clinical Research

Brandon, Florida, 33511, United States

Location

Accel Research - Edgewater Clinical Research Unit

Edgewater, Florida, 32132, United States

Location

Tory Sullivan, MD PA

North Miami Beach, Florida, 33162, United States

Location

Nona Pediatrics

Orlando, Florida, 32829, United States

Location

Accel Research - Ormond Clinical Research Unit

Ormond Beach, Florida, 32174, United States

Location

Olympian Clinical Research

St. Petersburg, Florida, 33706, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

DS Research

Clarksville, Indiana, 47129, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Avant Research Associates, LLC

Crowley, Louisiana, 70526, United States

Location

Clinical Trials Management, LLC

Metairie, Louisiana, 70006, United States

Location

DermAssociates, LLC

Rockville, Maryland, 20850, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

Oakland Hills Dermatology, PC

Auburn Hills, Michigan, 48326, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

Bexley Dermatology Research

Bexley, Ohio, 43209, United States

Location

Optima Research

Boardman, Ohio, 44512, United States

Location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

Location

Peak Research, LLC

Upper Saint Clair, Pennsylvania, 15241, United States

Location

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

North Texas Center for Clinical Research

Frisco, Texas, 75034, United States

Location

Center for Clinical Studies, Ltd, LLP

Houston, Texas, 77004, United States

Location

Houston Center for Clinical Research

Sugar Land, Texas, 77479, United States

Location

Premier Clinical Research, LLC

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

difamilast

Condition Hierarchy (Ancestors)

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

Study Officials

• Uma Srinivas Atmuri, MPharm MS

  Acrotech Biopharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: October 1, 2022
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (39)