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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05571943
Recruitment Status : Active, not recruiting
First Posted : October 7, 2022
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Acrotech Biopharma Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Difamilast Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Difamilast Ointment 1%
A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)
 Drug: Difamilast
Difamilast Ointment 1%


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Proportion of subjects who discontinue due to an AE over the study period [ Time Frame: 52-week study period ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05571943


Locations
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Sponsors and Collaborators
Acrotech Biopharma Inc.
Investigators
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Study Director: Uma S Atmuri, MPharm MS Acrotech Biopharma Inc.
More Information
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Responsible Party: Acrotech Biopharma Inc.
ClinicalTrials.gov Identifier: NCT05571943    
Other Study ID Numbers: MM36-302
First Posted: October 7, 2022    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases