Clinical trial NCT05571943: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Acrotech Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 542
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

   -

Primary outcomes:
measure: The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug
timeFrame: 52 week study period
measure: Proportion of subjects who discontinue due to an AE over the study period
timeFrame: 52-week study period
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Qualmedica Research, LLC
state: Alabama
city: Birmingham
country: United States
facility: AllerVie Health
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic-Dermatology
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Laguna Niguel
country: United States
facility: Southern CA Dermatology Skin and Laser
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute
state: California
city: Castle Rock
country: United States
facility: Clarity Dermatology, LLC
state: Colorado
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Brandon
country: United States
facility: TrueBlue Clinical Research
state: Florida
city: DeLand
country: United States
facility: Annexus Dermatology & Aethestics
state: Florida
city: Edgewater
country: United States
facility: Accel Research - Edgewater Clinical Research Unit
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research
state: Florida
city: Naples
country: United States
facility: Kirsch Dermatology
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, MD PA
state: Florida
city: Orlando
country: United States
facility: Pure Skin Dermatology & Aesthetics
state: Florida
city: Orlando
country: United States
facility: Nona Pediatrics
state: Florida
city: Ormond Beach
country: United States
facility: Accel Research - Ormond Clinical Research Unit
state: Florida
city: Saint Petersburg
country: United States
facility: Olympian Clinical Research
state: Florida
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Clarksville
country: United States
facility: DS Research
state: Indiana
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: West Lafayette
country: United States
facility: Options Research Group, LLC
state: Indiana
city: Overland Park
country: United States
facility: Meridian Clinical Research
state: Kansas
city: Bowling Green
country: United States
facility: Qualmedica Research, LLC
state: Kentucky
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Covington
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Crowley
country: United States
facility: Avant Research Associates, LLC
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Rockville
country: United States
facility: DermAssociates, LLC
state: Maryland
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology, PC
state: Michigan
city: Waterford
country: United States
facility: Michigan Dermatology Institute
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Kirksville
country: United States
facility: Cleaver Dermatology
state: Missouri
city: Las Vegas
country: United States
facility: Vivida Dermatology
state: Nevada
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Boardman
country: United States
facility: Optima Research
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
city: Columbus
country: United States
facility: Optimed Research
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Peak Research, LLC
state: Pennsylvania
city: Anderson
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee, LLC
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Austin
country: United States
facility: Derm Research
state: Texas
city: College Station
country: United States
facility: J&S Studies
state: Texas
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, Ltd, LLP
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: Sugar Land
country: United States
facility: Houston Center for Clinical Research
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research, LLC
state: Washington
Study officials:
affiliation: Acrotech Biopharma Inc.
name: Uma S Atmuri, MPharm MS
role: STUDY_DIRECTOR
References: