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The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis (ARQ-151-201)

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Roflumilast Cream 0.3%
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 Plaque Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • Participants legally competent to sign and give informed consent
  • Males and females ages 18 years and older (inclusive)
  • Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
  • Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
  • In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
  • Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

  • Planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed.
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  • Previous treatment with roflumilast cream or its active ingredient
  • Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
  • Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
  • 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.

Sites / Locations

  • Arcutis Clinical Site 35
  • Arcutis Clinical Site 29
  • Arcutis Clinical Site 28
  • Arcutis Clinical Site 27
  • Arcutis Clinical Site 12
  • Arcutis Clinical Site 16
  • Arcutis Clinical Site 21
  • Arcutis Clinical Site 34
  • Arcutis Clinical Site 33
  • Arcutis Clinical Site 20
  • Arcutis Clinical Site 22
  • Arcutis Clinical Site 14
  • Arcutis Clinical Site 39
  • Arcutis Clinical Site 15
  • Arcutis Clinical Site 19
  • Arcutis Clinical Site 37
  • Arcutis Clinical Site 13
  • Arcutis Clinical Site 23
  • Arcutis Clinical Site 24
  • Arcutis Clinical Site 31
  • Arcutis Clinical Site 18
  • Arcutis Clinical Site 11
  • Arcutis Clinical Site 38
  • Arcutis Clinical Site 10
  • Arcutis Clinical Site 25
  • Arcutis Clinical Site 26
  • Arcutis Clinical Site 32
  • Arcutis Clinical Site 17
  • Arcutis Clinical Site 30
  • Arcutis Clinical Site 36

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Roflumilast Cream 0.3%

Roflumilast Cream 0.15%

Vehicle Cream

Arm Description

Roflumilast cream 0.3% topically applied QD for 12 weeks.

Roflumilast cream 0.15% topically applied QD for 12 weeks.

Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.

Secondary Outcome Measures

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score
The percent change from baseline in mPASI score is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. For scoring, the body is divided into four sections (head [h]: 10% of a person's skin; arms [a] 20%; trunk [t] 30%; legs (l] 40%); for each section, the percent of area involved is estimated from 0 (0% involved) to 6 (90 to 100% involved). Then, within each area, the severity is estimated by three clinical signs: erythema ('E'; redness), induration ('T'; thickness), and desquamation ('S'; scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum severity possible. Each of these areas is scored by itself, and then the four scores are combined into the final mPASI, using the formula mPASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 0.4 (El + Tl + Sl) Al.
Percent Change From Baseline in Body Surface Area (BSA) Affected
The BSA affected by psoriasis was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. The mean percent change from baseline in BSA is presented.
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') plus a 2-grade improvement from baseline is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline
The percentage of participants (who had intertriginous area involvement with an I-IGA score of at least mild at baseline) with at least a 2-grade improvement in I-IGA score at Weeks 4, 6, 8, and 12 is presented.
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score
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. The mean (SD) change in WI-NRS score from baseline is presented.
Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction
The percentage of participants who had baseline WI-NRS scores ≥6 who achieved a 4-point reduction in WI-NRS score at Weeks 4, 6, 8, and 12 is reported. 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.
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline
The percentage of subjects achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline
The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. The percentage of subjects achieving a 90% reduction in mPASI (eg, mPASI-90) score relative to baseline is presented.
Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 11 ("worst imaginable symptoms"). Scores range from 0 to 176, with higher scores indicating greater symptom severity. The mean (SD) change in PSD total score relative to baseline is presented for each treatment arm.
Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score
The Itch-Related Sleep Loss NRS is a single item scale scored from 0 ("no itch-related sleep loss") to 10 ("itch-related sleep loss as bad as it could be") assessing the severity of itch-related sleep loss in the past 24 hours. The mean (SD) change from the baseline NRS score is presented for each treatment arm.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
The DLQI is a 10-item scale asking subject to rate the severity of symptoms during the past week. Each item is scored from 0 ("not at all" or "not relevant") to 3 or 4 ("very much") [2 questions are scored 0 to 3 and 8 questions are scored 0 to 4]. The total DLQI score ranges from 0 to 48, with higher scores indicating greater symptom severity. The mean (SD) change from baseline DLQI score is presented.
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Two items from the PSD asking participants to rate the overall severity of psoriasis-related itching and pain during the past 24 hours are presented. Each item is scored on an 11-point scale ranging from 0 ("no symptom") to 10 ("worst imaginable symptom"), with lower scores indicating lower symptoms severity. The mean (SD) score is presented for each treatment arm.

Full Information

First Posted
August 16, 2018
Last Updated
August 31, 2022
Sponsor
Arcutis Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03638258
Brief Title
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
Acronym
ARQ-151-201
Official Title
A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream 0.3% and ARQ-151 Cream 0.15% Administered Once Daily in Subjects With Chronic Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 21, 2018 (Actual)
Primary Completion Date
May 29, 2019 (Actual)
Study Completion Date
May 29, 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
This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel group, double blind, vehicle-controlled study
Masking
ParticipantInvestigator
Masking Description
Roflumilast drug product will be supplied as a 0.3% and 0.15% cream. The matching vehicle cream will contain only excipients of roflumilast cream.
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roflumilast Cream 0.3%
Arm Type
Experimental
Arm Description
Roflumilast cream 0.3% topically applied QD for 12 weeks.
Arm Title
Roflumilast Cream 0.15%
Arm Type
Experimental
Arm Description
Roflumilast cream 0.15% topically applied QD for 12 weeks.
Arm Title
Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Roflumilast Cream 0.3%
Other Intervention Name(s)
ARQ-151
Intervention Description
Applied once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Roflumilast Cream 0.15%
Other Intervention Name(s)
ARQ-151
Intervention Description
Applied once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Intervention Description
Applied once daily for 12 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6
Description
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
Description
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Time Frame
Weeks 4, 8, and 12
Title
Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score
Description
The percent change from baseline in mPASI score is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. For scoring, the body is divided into four sections (head [h]: 10% of a person's skin; arms [a] 20%; trunk [t] 30%; legs (l] 40%); for each section, the percent of area involved is estimated from 0 (0% involved) to 6 (90 to 100% involved). Then, within each area, the severity is estimated by three clinical signs: erythema ('E'; redness), induration ('T'; thickness), and desquamation ('S'; scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum severity possible. Each of these areas is scored by itself, and then the four scores are combined into the final mPASI, using the formula mPASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 0.4 (El + Tl + Sl) Al.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Percent Change From Baseline in Body Surface Area (BSA) Affected
Description
The BSA affected by psoriasis was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. The mean percent change from baseline in BSA is presented.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline
Description
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') plus a 2-grade improvement from baseline is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline
Description
The percentage of participants (who had intertriginous area involvement with an I-IGA score of at least mild at baseline) with at least a 2-grade improvement in I-IGA score at Weeks 4, 6, 8, and 12 is presented.
Time Frame
Weeks 4, 6, 8, and 12
Title
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score
Description
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. The mean (SD) change in WI-NRS score from baseline is presented.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction
Description
The percentage of participants who had baseline WI-NRS scores ≥6 who achieved a 4-point reduction in WI-NRS score at Weeks 4, 6, 8, and 12 is reported. 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.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline
Description
The percentage of subjects achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline
Description
The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. The percentage of subjects achieving a 90% reduction in mPASI (eg, mPASI-90) score relative to baseline is presented.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score
Description
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 11 ("worst imaginable symptoms"). Scores range from 0 to 176, with higher scores indicating greater symptom severity. The mean (SD) change in PSD total score relative to baseline is presented for each treatment arm.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score
Description
The Itch-Related Sleep Loss NRS is a single item scale scored from 0 ("no itch-related sleep loss") to 10 ("itch-related sleep loss as bad as it could be") assessing the severity of itch-related sleep loss in the past 24 hours. The mean (SD) change from the baseline NRS score is presented for each treatment arm.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Description
The DLQI is a 10-item scale asking subject to rate the severity of symptoms during the past week. Each item is scored from 0 ("not at all" or "not relevant") to 3 or 4 ("very much") [2 questions are scored 0 to 3 and 8 questions are scored 0 to 4]. The total DLQI score ranges from 0 to 48, with higher scores indicating greater symptom severity. The mean (SD) change from baseline DLQI score is presented.
Time Frame
Baseline (Day 1) and Weeks 4, 6, 8, and 12
Title
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
Description
Two items from the PSD asking participants to rate the overall severity of psoriasis-related itching and pain during the past 24 hours are presented. Each item is scored on an 11-point scale ranging from 0 ("no symptom") to 10 ("worst imaginable symptom"), with lower scores indicating lower symptoms severity. The mean (SD) score is presented for each treatment arm.
Time Frame
Weeks 4, 6, 8, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants legally competent to sign and give informed consent Males and females ages 18 years and older (inclusive) Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial. In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator. Exclusion Criteria: Planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. Previous treatment with roflumilast cream or its active ingredient Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication. 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.
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 35
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Arcutis Clinical Site 29
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Arcutis Clinical Site 28
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Arcutis Clinical Site 27
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Arcutis Clinical Site 12
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Arcutis Clinical Site 16
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Arcutis Clinical Site 21
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Arcutis Clinical Site 34
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Arcutis Clinical Site 33
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Arcutis Clinical Site 20
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Arcutis Clinical Site 22
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Arcutis Clinical Site 14
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Arcutis Clinical Site 39
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Arcutis Clinical Site 15
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Arcutis Clinical Site 19
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Arcutis Clinical Site 37
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Arcutis Clinical Site 13
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Arcutis Clinical Site 23
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Arcutis Clinical Site 24
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Arcutis Clinical Site 31
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Arcutis Clinical Site 18
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Arcutis Clinical Site 11
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Arcutis Clinical Site 38
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Arcutis Clinical Site 10
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
Arcutis Clinical Site 25
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Arcutis Clinical Site 26
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Arcutis Clinical Site 32
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Arcutis Clinical Site 17
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Arcutis Clinical Site 30
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Arcutis Clinical Site 36
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36370336
Citation
Stein Gold L, Alonso-Llamazares J, Draelos ZD, Gooderham MJ, Kempers SE, Kircik LH, Lebwohl MG, Papp KA, Pariser DM, Toth DP, Yosipovitch G, Higham RC, Feng A, Berk DR. Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial. Am J Clin Dermatol. 2023 Mar;24(2):305-313. doi: 10.1007/s40257-022-00739-3. Epub 2022 Nov 12.
Results Reference
derived
PubMed Identifier
32668113
Citation
Lebwohl MG, Papp KA, Stein Gold L, Gooderham MJ, Kircik LH, Draelos ZD, Kempers SE, Zirwas M, Smith K, Osborne DW, Trotman ML, Navale L, Merritt C, Berk DR, Welgus H; ARQ-151 201 Study Investigators. Trial of Roflumilast Cream for Chronic Plaque Psoriasis. N Engl J Med. 2020 Jul 16;383(3):229-239. doi: 10.1056/NEJMoa2000073.
Results Reference
derived

Learn more about this trial

The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

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