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Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-I)

Primary Purpose

Atopic Dermatitis Eczema

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ARQ-151 Active
ARQ-151 Vehicle
Sponsored by
Arcutis Biotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis Eczema

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
  2. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
  3. Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
  4. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
  5. In good health as judged by the Investigator.
  6. 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 and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
  4. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  5. Previous treatment with ARQ-151.
  6. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
  7. 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.
  8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.

Sites / Locations

  • Arcutis Clinical Site 57
  • Arcutis Clinical Site 34
  • Arcutis Clinical Site 58
  • Arcutis Clinical Site 40
  • Arcutis Clinical Site 06
  • Arcutis Clinical Site 52
  • Arcutis Clinical Site 05
  • Arcutis Clinical Site 08
  • Arcutis Clinical Site 62
  • Arcutis Clinical Site 30
  • Arcutis Clinical Site 04
  • Arcutis Clinical Site 15
  • Arcutis Clinical Site 39
  • Arcutis Clinical Site 38
  • Arcutis Clinical Site 01
  • Arcutis Clinical Site 61
  • Arcutis Clinical Site 26
  • Arcutis Clinical Site 13
  • Arcutis Clinical Site 48
  • Arcutis Clinical Site 02
  • Arcutis Clinical Site 03
  • Arcutis Clinical Site 36
  • Arcutis Clinical Site 55
  • Arcutis Clinical Site 54
  • Arcutis Clinical Site 46
  • Arcutis Clinical Site 37
  • Arcutis Clinical Site 10
  • Arcutis Clinical Site 33
  • Arcutis Clinical Site 42
  • Arcutis Clinical Site 17
  • Arcutis Clinical Site 16
  • Arcutis Clinical Site 14
  • Arcutis Clinical Site 35
  • Arcutis Clinical Site 101
  • Arcutis Clinical Site 31
  • Arcutis Clinical Site 19
  • Arcutis Clinical Site 43
  • Arcutis Clinical Site 27
  • Arcutis Clinical Site 20
  • Arcutis Clinical Site 28
  • Arcutis Clinical Site 21
  • Arcutis Clinical Site 12
  • Arcutis Clinical Site 41
  • Arcutis Clinical Site 29
  • Arcutis Clinical Site 11
  • Clinical Site 25
  • Arcutis Clinical Site 32
  • Arcutis Clinical Site 09
  • Arcutis Clinical Site 24

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ARQ-151 Cream 0.15%

ARQ-151 Vehicle Cream

Arm Description

Active comparator

Placebo comparator

Outcomes

Primary Outcome Measures

IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at 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

Subjects with a vIGA-AD score of 'Moderate' at randomization, vIGA-AD Success at 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).
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 4
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 2
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 1
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Achievement of at least a 75% (percent) reduction in the Eczema Area and Severity Index (EASI-75) at 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.
vIGA-AD of 'clear' or 'almost clear' at 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).
vIGA-AD success at 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).
vIGA-AD success at 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).
vIGA-AD of 'clear' or 'almost clear' at 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).
vIGA-AD of 'clear' or 'almost clear' at 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).

Full Information

First Posted
February 24, 2021
Last Updated
July 25, 2023
Sponsor
Arcutis Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04773587
Brief Title
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Acronym
INTEGUMENT-I
Official Title
A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcutis Biotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
654 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARQ-151 Cream 0.15%
Arm Type
Experimental
Arm Description
Active comparator
Arm Title
ARQ-151 Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
ARQ-151 Active
Intervention Description
ARQ-151 Cream 0.15% - Active
Intervention Type
Drug
Intervention Name(s)
ARQ-151 Vehicle
Intervention Description
ARQ-151 Cream - Vehicle
Primary Outcome Measure Information:
Title
IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at Week 4.
Description
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).
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Subjects with a vIGA-AD score of 'Moderate' at randomization, vIGA-AD Success at Week 4
Description
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).
Time Frame
Week 4
Title
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 4
Description
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time Frame
Week 4
Title
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 2
Description
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time Frame
Week 2
Title
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 1
Description
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time Frame
Week 1
Title
Achievement of at least a 75% (percent) reduction in the Eczema Area and Severity Index (EASI-75) at Week 4
Description
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.
Time Frame
Week 4
Title
vIGA-AD of 'clear' or 'almost clear' at Week 4
Description
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).
Time Frame
Week 4
Title
vIGA-AD success at Week 2
Description
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).
Time Frame
Week 2
Title
vIGA-AD success at Week 1
Description
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).
Time Frame
Week 1
Title
vIGA-AD of 'clear' or 'almost clear' at Week 2
Description
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).
Time Frame
Week 2
Title
vIGA-AD of 'clear' or 'almost clear' at Week 1
Description
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).
Time Frame
Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada. Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. In good health as judged by the Investigator. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator. Exclusion Criteria: 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 Has unstable AD or any consistent requirement for high potency topical steroids. Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. Previous treatment with ARQ-151. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening. 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. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Berk, MD
Organizational Affiliation
Arcutis Biotherapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arcutis Clinical Site 57
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
Arcutis Clinical Site 34
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Arcutis Clinical Site 58
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Arcutis Clinical Site 40
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Arcutis Clinical Site 06
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Arcutis Clinical Site 52
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Facility Name
Arcutis Clinical Site 05
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Arcutis Clinical Site 08
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
Country
United States
Facility Name
Arcutis Clinical Site 62
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Facility Name
Arcutis Clinical Site 30
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Arcutis Clinical Site 04
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Arcutis Clinical Site 15
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Arcutis Clinical Site 39
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Arcutis Clinical Site 38
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Arcutis Clinical Site 01
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Arcutis Clinical Site 61
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Arcutis Clinical Site 26
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Arcutis Clinical Site 13
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
33770
Country
United States
Facility Name
Arcutis Clinical Site 48
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Facility Name
Arcutis Clinical Site 02
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Arcutis Clinical Site 03
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Arcutis Clinical Site 36
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Arcutis Clinical Site 55
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Facility Name
Arcutis Clinical Site 54
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Arcutis Clinical Site 46
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Arcutis Clinical Site 37
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Arcutis Clinical Site 10
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Arcutis Clinical Site 33
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Arcutis Clinical Site 42
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Arcutis Clinical Site 17
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Arcutis Clinical Site 16
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Arcutis Clinical Site 14
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Arcutis Clinical Site 35
City
Newtown Square
State/Province
Pennsylvania
ZIP/Postal Code
19073
Country
United States
Facility Name
Arcutis Clinical Site 101
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Arcutis Clinical Site 31
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Arcutis Clinical Site 19
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Arcutis Clinical Site 43
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Arcutis Clinical Site 27
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Arcutis Clinical Site 20
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Arcutis Clinical Site 28
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Arcutis Clinical Site 21
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Arcutis Clinical Site 12
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Arcutis Clinical Site 41
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
Arcutis Clinical Site 29
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Arcutis Clinical Site 11
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
Clinical Site 25
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Arcutis Clinical Site 32
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Arcutis Clinical Site 09
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Arcutis Clinical Site 24
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

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