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

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Difamilast
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:

  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

    -

Sites / Locations

  • Qualmedica Research, LLCRecruiting
  • AllerVie HealthRecruiting
  • Elite Clinical Studies, LLCRecruiting
  • NEA Baptist Clinic-DermatologyRecruiting
  • First OC DermatologyRecruiting
  • Center for Dermatology Clinical Research, Inc.Recruiting
  • Southern CA Dermatology Skin and LaserRecruiting
  • Antelope Valley Clinical TrialsRecruiting
  • Dermatology Research AssociatesRecruiting
  • Clinical Trials Research InstituteRecruiting
  • Clarity Dermatology, LLCRecruiting
  • IMMUNOe Research CentersRecruiting
  • TrueBlue Clinical ResearchRecruiting
  • Annexus Dermatology & AethesticsRecruiting
  • Accel Research - Edgewater Clinical Research UnitRecruiting
  • Skin Care ResearchRecruiting
  • Kirsch DermatologyRecruiting
  • Tory Sullivan, MD PARecruiting
  • Pure Skin Dermatology & AestheticsRecruiting
  • Nona PediatricsRecruiting
  • Accel Research - Ormond Clinical Research UnitRecruiting
  • Olympian Clinical ResearchRecruiting
  • Solaris Clinical ResearchRecruiting
  • Arlington DermatologyRecruiting
  • DS ResearchRecruiting
  • Qualmedica Research, LLCRecruiting
  • Dawes Fretzin Clinical Research Group, LLCRecruiting
  • The Indiana Clinical Trials CenterRecruiting
  • South Bend ClinicRecruiting
  • Options Research Group, LLCRecruiting
  • Meridian Clinical ResearchRecruiting
  • Qualmedica Research, LLCRecruiting
  • DS ResearchRecruiting
  • Clinical Trials Management, LLCRecruiting
  • Avant Research Associates, LLCRecruiting
  • Clinical Trials Management, LLCRecruiting
  • DermAssociates, LLCRecruiting
  • Metro Boston Clinical PartnersRecruiting
  • Oakland Hills Dermatology, PCRecruiting
  • Michigan Dermatology InstituteRecruiting
  • Minnesota Clinical Study CenterRecruiting
  • Cleaver DermatologyRecruiting
  • Vivida DermatologyRecruiting
  • Forest Hills Dermatology GroupRecruiting
  • Bexley Dermatology ResearchRecruiting
  • Optima ResearchRecruiting
  • Remington-Davis, Inc.Recruiting
  • Optimed ResearchRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Dermatology Associates of Plymouth MeetingRecruiting
  • Peak Research, LLCRecruiting
  • Palmetto Clinical Trial Services, LLCRecruiting
  • Coastal Pediatric ResearchRecruiting
  • International Clinical Research - Tennessee, LLCRecruiting
  • Arlington Research Center, Inc.Recruiting
  • Derm ResearchRecruiting
  • J&S StudiesRecruiting
  • North Texas Center for Clinical ResearchRecruiting
  • Center for Clinical Studies, Ltd, LLPRecruiting
  • Research Your HealthRecruiting
  • Houston Center for Clinical ResearchRecruiting
  • Center for Clinical StudiesRecruiting
  • Premier Clinical Research, LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Difamilast Ointment 1%

Arm Description

A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)

Outcomes

Primary Outcome Measures

The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug
Proportion of subjects who discontinue due to an AE over the study period

Secondary Outcome Measures

Full Information

First Posted
October 5, 2022
Last Updated
October 19, 2023
Sponsor
Acrotech Biopharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05571943
Brief Title
A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (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

5. Study Description

Brief 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.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Difamilast Ointment 1%
Arm Type
Experimental
Arm Description
A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)
Intervention Type
Drug
Intervention Name(s)
Difamilast
Intervention Description
Difamilast Ointment 1%
Primary Outcome Measure Information:
Title
The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug
Time Frame
52 week study period
Title
Proportion of subjects who discontinue due to an AE over the study period
Time Frame
52-week study period

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 at Screening (Visit 1). 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 3 months prior to Screening . 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. 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: 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. Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD Subjects with significant systemic or localized infection Subjects with minimal/mild depression and suicidal ideation Subjects using restricted medications, biologics and alternative therapies, or using investigational drug -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Magajna, MS
Phone
208-719-7876
Email
smagajna@therapeuticsinc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uma S Atmuri, MPharm MS
Organizational Affiliation
Acrotech Biopharma Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Qualmedica Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
AllerVie Health
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Recruiting
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
NEA Baptist Clinic-Dermatology
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72405
Country
United States
Individual Site Status
Recruiting
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern CA Dermatology Skin and Laser
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Individual Site Status
Recruiting
Facility Name
Antelope Valley Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Research Institute
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Individual Site Status
Recruiting
Facility Name
Clarity Dermatology, LLC
City
Castle Rock
State/Province
Colorado
ZIP/Postal Code
80109
Country
United States
Individual Site Status
Recruiting
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Name
TrueBlue Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Annexus Dermatology & Aethestics
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research - Edgewater Clinical Research Unit
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Care Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Kirsch Dermatology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Name
Tory Sullivan, MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Name
Pure Skin Dermatology & Aesthetics
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Nona Pediatrics
City
Orlando
State/Province
Florida
ZIP/Postal Code
32829
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research - Ormond Clinical Research Unit
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Olympian Clinical Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33706
Country
United States
Individual Site Status
Recruiting
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Individual Site Status
Recruiting
Facility Name
Arlington Dermatology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Individual Site Status
Recruiting
Facility Name
DS Research
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Individual Site Status
Recruiting
Facility Name
Qualmedica Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Individual Site Status
Recruiting
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Individual Site Status
Recruiting
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Individual Site Status
Recruiting
Facility Name
Options Research Group, LLC
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Name
Qualmedica Research, LLC
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Individual Site Status
Recruiting
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Management, LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Name
Avant Research Associates, LLC
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
DermAssociates, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Name
Metro Boston Clinical Partners
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
Facility Name
Oakland Hills Dermatology, PC
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Dermatology Institute
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48328
Country
United States
Individual Site Status
Recruiting
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleaver Dermatology
City
Kirksville
State/Province
Missouri
ZIP/Postal Code
63501
Country
United States
Individual Site Status
Recruiting
Facility Name
Vivida Dermatology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Name
Forest Hills Dermatology Group
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Individual Site Status
Recruiting
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Individual Site Status
Recruiting
Facility Name
Optima Research
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Recruiting
Facility Name
Remington-Davis, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Name
Optimed Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Associates of Plymouth Meeting
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Individual Site Status
Recruiting
Facility Name
Peak Research, LLC
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Individual Site Status
Recruiting
Facility Name
Palmetto Clinical Trial Services, LLC
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Name
International Clinical Research - Tennessee, LLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Individual Site Status
Recruiting
Facility Name
Arlington Research Center, Inc.
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Recruiting
Facility Name
Derm Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremiah Fortenberry
Facility Name
J&S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Center for Clinical Research
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies, Ltd, LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Your Health
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Center for Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Clinical Research, LLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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