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

Primary Purpose

Atopic Dermatitis Eczema

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Roflumilast (ARQ-151) cream
Vehicle cream
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 31
  • Arcutis Clinical Site 51
  • Arcutis Clinical Site 46
  • Arcutis Clinical Site 19
  • Arcutis Clinical Site 36
  • Arcutis Clinical Site 13
  • Arcutis Clinical Site 54
  • Arcutis Clinical Site 55
  • Arcutis Clinical Site 30
  • Arcutis Clinical Site 37
  • Arcutis Clinical Site 58
  • Arcutis Clinical Site 41
  • Arcutis Clinical Site 11
  • Arcutis Clinical Site 57
  • Arcutis Clinical Site 62
  • Clinical Site 04
  • Arcutis Clinical Site 43
  • Arcutis Clinical Site 63
  • Arcutis Clinical Site 42
  • Arcutis Clinical Site 38
  • Arcutis Clinical Site 06
  • Arcutis Clinical Site 34
  • Arcutis Clinical Site 29
  • Arcutis Clinical Site 21
  • Arcutis Clinical Site 61
  • Arcutis Clinical Site 245
  • Arcutis Clinical Site 53
  • Arcutis Clinical Site 39
  • Arcutis Clinical Site 33
  • Arcutis Clinical Site 01
  • Arcutis Clinical Site 24
  • Arcutis Clinical Site 07
  • Arcutis Clinical Site 35
  • Arcutis Clinical Site 18
  • Arcutis Clinical Site 15
  • Clinical Site 05
  • Arcutis Clinical Site 03
  • Arcutis Clinical Site 59
  • Arcutis Clinical Site 250
  • Arcutis Clinical Site 52
  • Arcutis Clinical Site 02
  • Arcutis Clinical Site 32
  • Arcutis Clinical Site 22
  • Arcutis Clinical Site 17
  • Arcutis Clinical Site 12
  • Arcutis Clinical Site 09
  • Arcutis Clinical Site 26
  • Arcutis Clinical Site 20
  • Arcutis Clinical Site 23
  • Arcutis Clinical Site 25
  • Arcutis Clinical Site 16
  • Arcutis Clinical Site 08
  • Arcutis Clinical Site 27

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Roflumilast (ARQ-151) cream 0.15%

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 inthe 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 inthe 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 inthe 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 andSeverity 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
September 14, 2023
Sponsor
Arcutis Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04773600
Brief Title
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)
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
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
September 29, 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

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
683 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roflumilast (ARQ-151) cream 0.15%
Arm Type
Active Comparator
Arm Description
Active comparator
Arm Title
Vehicle cream
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
Roflumilast (ARQ-151) cream
Other Intervention Name(s)
Roflumilast cream
Intervention Description
Roflumilast (ARQ-151) cream 0.15% - Active
Intervention Type
Drug
Intervention Name(s)
Vehicle cream
Intervention Description
Vehicle cream
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 inthe 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 inthe 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 inthe 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 andSeverity 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 31
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Arcutis Clinical Site 51
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Arcutis Clinical Site 46
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Arcutis Clinical Site 19
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Arcutis Clinical Site 36
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Arcutis Clinical Site 13
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Arcutis Clinical Site 54
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Arcutis Clinical Site 55
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Arcutis Clinical Site 30
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Arcutis Clinical Site 37
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Arcutis Clinical Site 58
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Arcutis Clinical Site 41
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Arcutis Clinical Site 11
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Arcutis Clinical Site 57
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Arcutis Clinical Site 62
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Clinical Site 04
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Arcutis Clinical Site 43
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Arcutis Clinical Site 63
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Arcutis Clinical Site 42
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Arcutis Clinical Site 38
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70448
Country
United States
Facility Name
Arcutis Clinical Site 06
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Arcutis Clinical Site 34
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Arcutis Clinical Site 29
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Arcutis Clinical Site 21
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Arcutis Clinical Site 61
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Arcutis Clinical Site 245
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Arcutis Clinical Site 53
City
New York
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
Arcutis Clinical Site 39
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Arcutis Clinical Site 33
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Arcutis Clinical Site 01
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Arcutis Clinical Site 24
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Arcutis Clinical Site 07
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Arcutis Clinical Site 35
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Arcutis Clinical Site 18
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Arcutis Clinical Site 15
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Clinical Site 05
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Arcutis Clinical Site 03
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Arcutis Clinical Site 59
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Arcutis Clinical Site 250
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Arcutis Clinical Site 52
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Arcutis Clinical Site 02
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Arcutis Clinical Site 32
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Arcutis Clinical Site 22
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Arcutis Clinical Site 17
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Arcutis Clinical Site 12
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Arcutis Clinical Site 09
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Arcutis Clinical Site 26
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Arcutis Clinical Site 20
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
Arcutis Clinical Site 23
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Arcutis Clinical Site 25
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Facility Name
Arcutis Clinical Site 16
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Arcutis Clinical Site 08
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 5L4
Country
Canada
Facility Name
Arcutis Clinical Site 27
City
Québec
State/Province
Quebec
ZIP/Postal Code
H3Z 2S6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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