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

Primary Purpose

Atopic Dermatitis

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Difamilast
Placebo
Sponsored by
Acrotech Biopharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Important Inclusion Criteria: 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 Important Exclusion Criteria: 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.,

Sites / Locations

  • AllerVie Health
  • Elite Clinical Studies, LLC
  • NEA Baptist Clinic-Dermatology
  • First OC Dermatology
  • Center for Dermatology Clinical Research, Inc.
  • Antelope Valley Clinical Trials
  • Dermatology Research Associates
  • Shahram Jacobs, MD Inc.
  • Clinical Trials Research Institute
  • IMMUNOe Research Centers
  • TrueBlue Clinical Research
  • Accel Research - Edgewater Clinical Research Unit
  • Tory Sullivan, MD PA
  • Nona Pediatrics
  • Accel Research - Ormond Clinical Research Unit
  • Olympian Clinical Research
  • Arlington Dermatology
  • DS Research
  • Dawes Fretzin Clinical Research Group, LLC
  • The Indiana Clinical Trials Center
  • South Bend Clinic
  • DS Research
  • Avant Research Associates, LLC
  • Clinical Trials Management, LLC
  • DermAssociates, LLC
  • Metro Boston Clinical Partners
  • Oakland Hills Dermatology, PC
  • Minnesota Clinical Study Center
  • Dermatology Consulting Services, PLLC
  • Bexley Dermatology Research
  • Optima Research
  • Remington-Davis, Inc.
  • Peak Research, LLC
  • International Clinical Research - Tennessee LLC
  • Arlington Research Center, Inc.
  • North Texas Center for Clinical Research
  • Center for Clinical Studies, Ltd, LLP
  • Houston Center for Clinical Research
  • Premier Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Difamilast Ointment

Vehicle Controlled

Arm Description

1% Difamilast Ointment

Matching placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2022
Last Updated
June 2, 2023
Sponsor
Acrotech Biopharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05608343
Brief Title
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acrotech Biopharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Difamilast Ointment
Arm Type
Active Comparator
Arm Description
1% Difamilast Ointment
Arm Title
Vehicle Controlled
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Difamilast
Intervention Description
Off-white ointment containing active ingredient, petrolatum and other ingredients
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Difamilast (Study drug) ointment without active ingradient
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Baseline, Day 29
Secondary Outcome Measure Information:
Title
To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD
Description
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
Time Frame
Baseline, Day 15, Day 22 and Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Important Inclusion Criteria: 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 Important Exclusion Criteria: 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.,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uma Srinivas Atmuri, MPharm MS
Organizational Affiliation
Acrotech Biopharma Inc.
Official's Role
Study Director
Facility Information:
Facility Name
AllerVie Health
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
NEA Baptist Clinic-Dermatology
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72405
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Antelope Valley Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Shahram Jacobs, MD Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Clinical Trials Research Institute
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
TrueBlue Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Accel Research - Edgewater Clinical Research Unit
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Tory Sullivan, MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Nona Pediatrics
City
Orlando
State/Province
Florida
ZIP/Postal Code
32829
Country
United States
Facility Name
Accel Research - Ormond Clinical Research Unit
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Olympian Clinical Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33706
Country
United States
Facility Name
Arlington Dermatology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
DS Research
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Avant Research Associates, LLC
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
DermAssociates, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Metro Boston Clinical Partners
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Oakland Hills Dermatology, PC
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Dermatology Consulting Services, PLLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Optima Research
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Remington-Davis, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Peak Research, LLC
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
International Clinical Research - Tennessee LLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Arlington Research Center, Inc.
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
North Texas Center for Clinical Research
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Center for Clinical Studies, Ltd, LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Houston Center for Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Premier Clinical Research, LLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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