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

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Difamilast

• Registration Number: NCT05571943
• Lead Sponsor: Acrotech Biopharma Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-07
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 542

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Difamilast Ointment 1%	Difamilast	A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who discontinue due to an AE over the study period	52-week study period
The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug	52 week study period

Trial Locations

Locations (59)

Qualmedica Research, LLC; 🇺🇸 Bowling Green, Kentucky, United States

AllerVie Health; 🇺🇸 Birmingham, Alabama, United States

Elite Clinical Studies, LLC; 🇺🇸 Phoenix, Arizona, United States

NEA Baptist Clinic-Dermatology; 🇺🇸 Jonesboro, Arkansas, United States

First OC Dermatology; 🇺🇸 Fountain Valley, California, United States

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Southern CA Dermatology Skin and Laser; 🇺🇸 Laguna Niguel, California, United States

Antelope Valley Clinical Trials; 🇺🇸 Lancaster, California, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Clinical Trials Research Institute; 🇺🇸 Thousand Oaks, California, United States

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