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Atopic DermatitisPhase 3NCT05571943

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

A Phase 3 study testing Difamilast in people with Atopic Dermatitis, run by Acrotech Biopharma Inc. at 63 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Difamilast
Could I receive a placebo?
No, everyone receives an active treatment
How many people
542 participants
Where
63 sitesUnited States
Study dates
15 Sep 2022to 31 Jul 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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 -

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

United States63 sites

  • Palmetto Clinical Trial Services, LLC

    Anderson, South Carolina, 29621

  • Arlington Research Center, Inc.

    Arlington, Texas, 76011

  • Oakland Hills Dermatology, PC

    Auburn Hills, Michigan, 48326

  • Derm Research

    Austin, Texas, 78759

  • Bexley Dermatology Research

    Bexley, Ohio, 43209

  • Qualmedica Research, LLC

    Birmingham, Alabama, 35205

  • AllerVie Health

    Birmingham, Alabama, 35244

  • Optima Research

    Boardman, Ohio, 44512

  • Qualmedica Research, LLC

    Bowling Green, Kentucky, 42101

  • TrueBlue Clinical Research

    Brandon, Florida, 33511

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135

  • Clarity Dermatology, LLC

    Castle Rock, Colorado, 80109

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414

  • DS Research

    Clarksville, Indiana, 47129

  • J&S Studies

    College Station, Texas, 77845

  • Remington-Davis, Inc.

    Columbus, Ohio, 43215

  • Optimed Research

    Columbus, Ohio, 43235

  • Clinical Trials Management, LLC

    Covington, Louisiana, 70433

  • Avant Research Associates, LLC

    Crowley, Louisiana, 70526

  • Annexus Dermatology & Aethestics

    DeLand, Florida, 32720

  • Accel Research - Edgewater Clinical Research Unit

    Edgewater, Florida, 32132

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California, 94538

  • North Texas Center for Clinical Research

    Frisco, Texas, 75034

  • Skin Care Research

    Hollywood, Florida, 33021

  • Center for Clinical Studies, Ltd, LLP

    Houston, Texas, 77004

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • NEA Baptist Clinic-Dermatology

    Jonesboro, Arkansas, 72405

  • Forest Hills Dermatology Group

    Kew Gardens, New York, 11415

  • Cleaver Dermatology

    Kirksville, Missouri, 63501

  • Southern CA Dermatology Skin and Laser

    Laguna Niguel, California, 92677

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • Vivida Dermatology

    Las Vegas, Nevada, 89119

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • DS Research

    Louisville, Kentucky, 40241

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • International Clinical Research - Tennessee, LLC

    Murfreesboro, Tennessee, 37130

  • Kirsch Dermatology

    Naples, Florida, 34102

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112

  • Tory Sullivan, MD PA

    North Miami Beach, Florida, 33162

  • Pure Skin Dermatology & Aesthetics

    Orlando, Florida, 32819

  • Nona Pediatrics

    Orlando, Florida, 32829

  • Accel Research - Ormond Clinical Research Unit

    Ormond Beach, Florida, 32174

  • Meridian Clinical Research

    Overland Park, Kansas, 66210

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Research Your Health

    Plano, Texas, 75093

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania, 19462

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • DermAssociates, LLC

    Rockville, Maryland, 20850

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Premier Clinical Research, LLC

    Spokane, Washington, 99202

  • Olympian Clinical Research

    St. Petersburg, Florida, 33706

  • Houston Center for Clinical Research

    Sugar Land, Texas, 77479

  • Clinical Trials Research Institute

    Thousand Oaks, California, 91320

  • Peak Research, LLC

    Upper Saint Clair, Pennsylvania, 15241

  • Michigan Dermatology Institute

    Waterford, Michigan, 48328

  • Center for Clinical Studies

    Webster, Texas, 77598

  • Options Research Group, LLC

    West Lafayette, Indiana, 47906

Other trials in United States

About this study

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

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.

Being tested
Difamilast
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DifamilastDrug

    Difamilast Ointment 1%

Study groups in NCT05571943
Study groupRoleWhat they receive
Difamilast Ointment 1%ExperimentalA thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)
Receives: Drug: Difamilast

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug

    Measured: 52 week study period

  2. Proportion of subjects who discontinue due to an AE over the study period

    Measured: 52-week study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2022
  2. Study start15 Sep 2022
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
542 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05571943
Sponsor's protocol ID
MM36-302
Status last verified
Aug 2024
First submitted
5 Oct 2022
Last updated
9 Aug 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Difamilast in people with Atopic Dermatitis, run by Acrotech Biopharma Inc. at 63 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05571943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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