ClinicalTrials.Veeva

Menu

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

Acrotech Biopharma logo

Acrotech Biopharma

Status and phase

Active, not recruiting
Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Difamilast

Study type

Interventional

Funder types

Industry

Identifiers

NCT05571943
MM36-302

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

Difamilast Ointment 1%
Experimental group
Description:
A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)
Treatment:
Drug: Difamilast

Trial contacts and locations

63

Loading...

Central trial contact

Stephanie Magajna, MS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems