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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years and Over
Gender	All

More Inclusion & Exclusion 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. -

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05571943
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Acrotech Biopharma Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Uma S Atmuri, MPharm MS
Principal Investigator Affiliation	Acrotech Biopharma Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Atopic Dermatitis

Arms & Interventions

Arms

Experimental: Difamilast Ointment 1%

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

Interventions

Drug: - Difamilast

Difamilast Ointment 1%

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Qualmedica Research, LLC, Birmingham, Alabama

Status

Recruiting

Address

Qualmedica Research, LLC

Birmingham, Alabama, 35205

Site Contact

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