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Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

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ClinicalTrials.gov Identifier: NCT04845620
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.

Study Description
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Brief Summary:
This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: ARQ-151 Active Drug: ARQ-151 Vehicle Phase 3

Detailed Description:
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis
Actual Study Start Date : April 7, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: ARQ-151 Cream 0.05%
Active comparator
 Drug: ARQ-151 Active
ARQ-151 Cream 0.05% - Active
Placebo Comparator: ARQ-151 Vehicle Cream
Placebo comparator
 Drug: ARQ-151 Vehicle
ARQ-151 Cream - Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at Week 4. [ Time Frame: Week 4 ]
    The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).


Secondary Outcome Measures :
  1. In subjects with vIGA-AD score of 'Moderate' at randomization, IGA Success at Week 4 [ Time Frame: Week 4 ]
    IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).

  2. In subjects with vIGA-AD score of 'Moderate' at randomization, achievement of at least 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 [ Time Frame: Week 4 ]
    EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.

  3. In subjects with vIGA-AD score of 'Moderate' at randomization, vIGA-AD score of 'clear' or 'almost clear' at Week 4 [ Time Frame: Week 4 ]
    The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).

  4. vIGA-AD success at Week 2 [ Time Frame: Week 2 ]
    The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).

  5. vIGA-AD success at Week 1 [ Time Frame: Week 1 ]
    The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).

  6. vIGA-AD of 'clear' or 'almost 'clear' at Week 2 [ Time Frame: Week 2 ]
    The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).

  7. vIGA-AD of 'clear' or 'almost 'clear' at Week 1 [ Time Frame: Week 1 ]
    The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent by parent(s) or legal guardian as required by local laws.
  2. Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).
  3. Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
  4. In good health as judged by the Investigator.
  5. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

  1. Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
  2. Has unstable AD or any consistent requirement for high potency topical steroids.
  3. Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
  4. Previous treatment with ARQ-151.
  5. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
  6. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled (in other studies of ARQ-151) subjects living in the same house.
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): NCT04845620


Contacts
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Contact: Arcutis Medical Information 1-844-692-6729 medinfo@arcutis.com

Locations
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Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
Investigators
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Study Director: David Berk, MD Arcutis Biotherapeutics, Inc.
More Information
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Responsible Party: Arcutis Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04845620    
Other Study ID Numbers: ARQ-151-315
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023

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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