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Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Roflumilast Cream 0.05%
Roflumilast Cream 0.15%
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

Eligibility Criteria

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

Inclusion Criteria:

  1. Participants legally competent to sign and give informed consent or, in the case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local laws.
  2. Males and females ages 12 years and older (inclusive) at the time of consent.
  3. Clinical diagnosis of active atopic dermatitis for at least 6 months.
  4. BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline.
  5. vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' ('2') or 'moderate ('3') at Baseline.
  6. EASI (Eczema Area and Severity Index) score of ≥ 5 at Baseline.
  7. Females of childbearing potential must have a negative serum pregnancy test at Screening and, if sexually active, agree to use birth control throughout the trial.
  8. In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests.

Exclusion Criteria:

  1. Subjects with any serious medical condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
  2. Evidence of skin conditions other than AD (atopic dermatitis) that would interfere with evaluation of the effect of the study medication.
  3. Pregnant or lactating women or women planning to become pregnant during the study.
  4. Known allergies to excipients in ARQ-151 cream.
  5. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors .
  6. Subjects who are unwilling to refrain from using a tanning bed as well as outdoor tanning or excessive sun exposure.
  7. Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies for the treatment of AD.

  8. Known or suspected:

    • severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C)
    • history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
    • within last 5 years, a history of severe depression, suicidal ideation
  9. Previous treatment with ARQ-151.
  10. Subjects with a history of chronic alcohol or drug abuse in past 6 months.
  11. Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
  12. Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
  13. Subjects with a history of a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
  14. Subjects with any condition which makes them unsuitable for clinical study participation or are family members of the clinical study site, clinical study staff, sponsor, or family members of enrolled subjects.

Sites / Locations

  • Arcutis Clinical Site 25
  • Arcutis Clinical Site 01
  • Arcutis Clinical Site 19
  • Arcutis Clinical Site 18
  • Arcutis Clinical Site 17
  • Arcutis Clinical Site 16
  • Arcutis Clinical Site 12
  • Arcutis Clinical Site 13
  • Arcutis Clinical Site 15
  • Arcutis Clinical Site 03
  • Arcutis Clinical Site 02
  • Arcutis Clinical Site 08
  • Arcutis Clinical Site 23
  • Arcutis Clinical Site 20
  • Arcutis Clinical Site 09
  • Arcutis Clinical Site 04
  • Arcutis Clinical Site 21
  • Arcutis Clinical Site 14
  • Arcutis Clinical Site 10
  • Arcutis Clinical Site 06

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Roflumilast Cream 0.05%

Roflumilast Cream 0.15%

Vehicle Cream

Arm Description

Participants apply roflumilast cream 0.05% QD for 28 days.

Participants apply roflumilast cream 0.15% QD for 28 days.

Participants apply vehicle cream QD for 28 days.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

Secondary Outcome Measures

Percentage Change From Baseline in EASI Total Score
The LS mean (SD) percentage change from baseline in EASI Total Score at Weeks 1, 2, and 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Mean Change From Baseline in EASI Total Score at Weeks 1 and 2
The LS mean (SD) change from baseline in EASI Total Score at Weeks 1 and 2 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50)
The number of participants with a decrease of at least 50% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)
The number of participants with a decrease of at least 75% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90)
The number of participants with a decrease of at least 90% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases.
Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100)
The number of participants with a decrease of 100% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases.
Mean Change From Baseline in Body Surface Area (BSA) Involvement
The LS mean (SE) change from baseline in BSA involvement at Weeks 1, 2, and 4 is presented. The BSA affected by AD was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. Negative scores indicate improvement of symptoms, whereas positive scores indicate worsening.
Worse Itch Numerical Rating Score (WI-NRS) Score Change
The LS mean (SE) change from baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity.
Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score
The number of participants achieving a ≥4-point improvement from Baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity.

Full Information

First Posted
April 10, 2019
Last Updated
January 13, 2023
Sponsor
Arcutis Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03916081
Brief Title
Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis
Official Title
A Phase 2, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% and ARQ-151 Cream 0.15% Administered QD (Quaque Die) in Adolescent and Adult Subjects With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (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
The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.
Detailed Description
This is a parallel group, double blind, vehicle-controlled study in which roflumilast cream 0.05% or 0.15% or vehicle is applied QD x 28 days to adolescent and adult subjects with atopic dermatitis. A subset of subjects will have serial PK testing, which will include the first few adolescents and adults enrolled in the study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roflumilast Cream 0.05%
Arm Type
Active Comparator
Arm Description
Participants apply roflumilast cream 0.05% QD for 28 days.
Arm Title
Roflumilast Cream 0.15%
Arm Type
Active Comparator
Arm Description
Participants apply roflumilast cream 0.15% QD for 28 days.
Arm Title
Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Participants apply vehicle cream QD for 28 days.
Intervention Type
Drug
Intervention Name(s)
Roflumilast Cream 0.05%
Other Intervention Name(s)
ARQ-151
Intervention Description
Roflumilast 0.05% cream for topical application
Intervention Type
Drug
Intervention Name(s)
Roflumilast Cream 0.15%
Other Intervention Name(s)
ARQ-151
Intervention Description
Roflumilast 0.15% cream for topical application
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Intervention Description
Inactive vehicle cream matched to roflumilast cream for topical application.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
Description
The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Percentage Change From Baseline in EASI Total Score
Description
The LS mean (SD) percentage change from baseline in EASI Total Score at Weeks 1, 2, and 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Time Frame
Baseline and Weeks 1, 2, and 4
Title
Mean Change From Baseline in EASI Total Score at Weeks 1 and 2
Description
The LS mean (SD) change from baseline in EASI Total Score at Weeks 1 and 2 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Time Frame
Baseline and Weeks 1 and 2
Title
Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50)
Description
The number of participants with a decrease of at least 50% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Time Frame
Baseline and Weeks 1, 2, and 4
Title
Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)
Description
The number of participants with a decrease of at least 75% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Time Frame
Baseline and Weeks 1, 2, and 4
Title
Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90)
Description
The number of participants with a decrease of at least 90% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases.
Time Frame
Baseline and Weeks 1, 2, and 4
Title
Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100)
Description
The number of participants with a decrease of 100% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases.
Time Frame
Baseline and Weeks 1, 2, and 4
Title
Mean Change From Baseline in Body Surface Area (BSA) Involvement
Description
The LS mean (SE) change from baseline in BSA involvement at Weeks 1, 2, and 4 is presented. The BSA affected by AD was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. Negative scores indicate improvement of symptoms, whereas positive scores indicate worsening.
Time Frame
Baseline and Weeks 1, 2, and 4
Title
Worse Itch Numerical Rating Score (WI-NRS) Score Change
Description
The LS mean (SE) change from baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity.
Time Frame
Baseline and Weeks 1, 2, and 4
Title
Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score
Description
The number of participants achieving a ≥4-point improvement from Baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity.
Time Frame
Baseline and Weeks 1, 2, and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants legally competent to sign and give informed consent or, in the case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local laws. Males and females ages 12 years and older (inclusive) at the time of consent. Clinical diagnosis of active atopic dermatitis for at least 6 months. BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline. vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' ('2') or 'moderate ('3') at Baseline. EASI (Eczema Area and Severity Index) score of ≥ 5 at Baseline. Females of childbearing potential must have a negative serum pregnancy test at Screening and, if sexually active, agree to use birth control throughout the trial. In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests. Exclusion Criteria: Subjects with any serious medical condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk. Evidence of skin conditions other than AD (atopic dermatitis) that would interfere with evaluation of the effect of the study medication. Pregnant or lactating women or women planning to become pregnant during the study. Known allergies to excipients in ARQ-151 cream. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors . Subjects who are unwilling to refrain from using a tanning bed as well as outdoor tanning or excessive sun exposure. Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies for the treatment of AD. Known or suspected: severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C) history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)) within last 5 years, a history of severe depression, suicidal ideation Previous treatment with ARQ-151. Subjects with a history of chronic alcohol or drug abuse in past 6 months. Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix. Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents. Subjects with a history of a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study. Subjects with any condition which makes them unsuitable for clinical study participation or are family members of the clinical study site, clinical study staff, sponsor, or family members of enrolled subjects.
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 25
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Arcutis Clinical Site 01
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Arcutis Clinical Site 19
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Arcutis Clinical Site 18
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Arcutis Clinical Site 17
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Arcutis Clinical Site 16
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Arcutis Clinical Site 12
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Arcutis Clinical Site 13
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Arcutis Clinical Site 15
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Arcutis Clinical Site 03
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Arcutis Clinical Site 02
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Arcutis Clinical Site 08
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Arcutis Clinical Site 23
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Arcutis Clinical Site 20
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Arcutis Clinical Site 09
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Arcutis Clinical Site 04
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Arcutis Clinical Site 21
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23224
Country
United States
Facility Name
Arcutis Clinical Site 14
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 4J9
Country
Canada
Facility Name
Arcutis Clinical Site 10
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Arcutis Clinical Site 06
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada

12. IPD Sharing Statement

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Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

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