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Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (DERMIS-1)

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Roflumilast 0.3% 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 Chronic Plaque Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • Participants legally competent to sign and give informed consent and if appropriate assent as required by local laws
  • Males and females ages 2 years and older (inclusive)
  • Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
  • Females of childbearing potential (FOCBP) must have a negative 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 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, tanning bed or other LED.
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  • Previous treatment with ARQ-151 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 investigational product
  • 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 Biotherapeutics Clinical Site 127
  • Arcutis Biotherapeutics Clinical Site 112
  • Arcutis Biotherapeutics Clinical Site 120
  • Arcutis Biotherapeutics Clinical Site 123
  • Arcutis Biotherapeutics Clinical Site 136
  • Arcutis Biotherapeutics Clinical Site 118
  • Arcutis Biotherapeutics Clinical Site 131
  • Arcutis Biotherapeutics Clinical Site 137
  • Arcutis Biotherapeutics Clinical Site 105
  • Arcutis Biotherapeutics Clinical Site 114
  • Arcutis Biotherapeutics Clinical Site 102
  • Arcutis Biotherapeutics Clinical Site 111
  • Arcutis Biotherapeutics Clinical Site 125
  • Arcutis Biotherapeutics Clinical Site 138
  • Arcutis Biotherapeutics Clinical Site 101
  • Arcutis Biotherapeutics Clinical Site 116
  • Arcutis Biotherapeutics Clinical Site 139
  • Arcutis Biotherapeutics Clinical Site 129
  • Arcutis Biotherapeutics Clinical Site 121
  • Arcutis Biotherapeutics Clinical Site 130
  • Arcutis Biotherapeutics Clinical Site 108
  • Arcutis Biotherapeutics Clinical Site 115
  • Arcutis Biotherapeutics Clinical Site 124
  • Arcutis Biotherapeutics Clinical Site 134
  • Arcutis Biotherapeutics Clinical Site 128
  • Arcutis Biotherapeutics Clinical Site 113
  • Arcutis Biotherapeutics Clinical Site 135
  • Arcutis Biotherapeutics Clinical Site 104
  • Arcutis Biotherapeutics Clinical Site 119
  • Arcutis Biotherapeutics Clinical Site 110
  • Arcutis Biotherapeutics Clinical Site 117
  • Arcutis Biotherapeutics Clinical Site 132
  • Arcutis Biotherapeutics Clinical Site 103
  • Arcutis Biotherapeutics Clinical Site 122
  • Arcutis Biotherapeutics Clinical Site 133
  • Arcutis Biotherapeutics Clinical Site 140
  • Arcutis Biotherapeutics Clinical Site 109
  • Arcutis Biotherapeutics Clinical Site 106
  • Arcutis Biotherapeutics Clinical Site 107
  • Arcutis Biotherapeutics Clinical Site 126

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rofumilast Cream 0.3%

Vehicle cream

Arm Description

Participants receive roflumilast cream 0.3% once daily for 8 weeks.

Participants receive vehicle cream once daily for 8 weeks.

Outcomes

Primary Outcome Measures

Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.

Secondary Outcome Measures

Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The time to achieve PASI-50 (defined as a 50% reduction from baseline in PASI score) is presented, and is based on observed data only.
Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-75 (defined as a 75% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) [higher scores indicate greater symptom severity]. The number of participants achieving PASI-90 (defined as a 90% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Number of Participants Achieving Intertriginous IGA (I-IGA) Success at Week 8
The number of participants achieving I-IGA success at Week 8 is presented. Success is defined as achievement of I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8 PLUS a ≥2-grade improvement in score from Baseline. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater symptom severity. Participant counts are based on observed data only.
Number of Participants Achieving Score of 'Clear' in I-IGA at Week 8
The number of participants achieving an IGA score of 0 ('clear') at Week 8 is presented (observed data only) for each arm. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'); higher scores indicate greater symptom severity.
Number of Participants Achieving Worst Itch Numerical Rating Score (WI-NRS) Success
The number of participants achieving success in WI-NRS is presented. Success is defined as achievement of a ≥ 4-point reduction in WI-NRS pruritus score in participants with WI-NRS pruritus score ≥ 4 at baseline. The WI-NRS is a 10 point scale ranging from 0 ('no itch') to 10 ('worst itch imaginable'), with higher scores indicating greater symptoms severity. Results are based on observed data only.
Change From Baseline in Psoriasis Symptoms Diary (PSD) 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 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The least squares (LS) mean (95% CI) change in PSD total score relative to baseline is presented for each treatment arm, with decreases from baseline indicating symptom improvement.

Full Information

First Posted
December 23, 2019
Last Updated
December 5, 2022
Sponsor
Arcutis Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04211363
Brief Title
Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Acronym
DERMIS-1
Official Title
A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
November 16, 2020 (Actual)
Study Completion Date
November 16, 2020 (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 double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Rofumilast Cream 0.3%
Arm Type
Experimental
Arm Description
Participants receive roflumilast cream 0.3% once daily for 8 weeks.
Arm Title
Vehicle cream
Arm Type
Placebo Comparator
Arm Description
Participants receive vehicle cream once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Roflumilast 0.3% cream
Other Intervention Name(s)
ARQ-151
Intervention Description
Roflumilast 0.3% cream for topical application.
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Intervention Description
Vehicle cream for topical application.
Primary Outcome Measure Information:
Title
Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8
Description
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Time Frame
Baseline (Day 1) and Week 8
Secondary Outcome Measure Information:
Title
Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)
Description
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The time to achieve PASI-50 (defined as a 50% reduction from baseline in PASI score) is presented, and is based on observed data only.
Time Frame
From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 121 days)
Title
Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)
Description
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-75 (defined as a 75% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Time Frame
Baseline (Day 1) and Week 8
Title
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
Description
Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) [higher scores indicate greater symptom severity]. The number of participants achieving PASI-90 (defined as a 90% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Time Frame
Baseline (Day 1) and Week 8
Title
Number of Participants Achieving Intertriginous IGA (I-IGA) Success at Week 8
Description
The number of participants achieving I-IGA success at Week 8 is presented. Success is defined as achievement of I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8 PLUS a ≥2-grade improvement in score from Baseline. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater symptom severity. Participant counts are based on observed data only.
Time Frame
Baseline (Day 1) and Week 8
Title
Number of Participants Achieving Score of 'Clear' in I-IGA at Week 8
Description
The number of participants achieving an IGA score of 0 ('clear') at Week 8 is presented (observed data only) for each arm. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'); higher scores indicate greater symptom severity.
Time Frame
Week 8
Title
Number of Participants Achieving Worst Itch Numerical Rating Score (WI-NRS) Success
Description
The number of participants achieving success in WI-NRS is presented. Success is defined as achievement of a ≥ 4-point reduction in WI-NRS pruritus score in participants with WI-NRS pruritus score ≥ 4 at baseline. The WI-NRS is a 10 point scale ranging from 0 ('no itch') to 10 ('worst itch imaginable'), with higher scores indicating greater symptoms severity. Results are based on observed data only.
Time Frame
Baseline (Day 1) and Weeks 2, 4, and 8
Title
Change From Baseline in Psoriasis Symptoms Diary (PSD) 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 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The least squares (LS) mean (95% CI) change in PSD total score relative to baseline is presented for each treatment arm, with decreases from baseline indicating symptom improvement.
Time Frame
Weeks 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 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 2 years and older (inclusive) Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator Females of childbearing potential (FOCBP) must have a negative 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 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, tanning bed or other LED. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. Previous treatment with ARQ-151 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 investigational product 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
Facility Information:
Facility Name
Arcutis Biotherapeutics Clinical Site 127
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 112
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 120
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 123
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 136
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 118
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 131
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 137
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 105
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 114
City
Plainfield
State/Province
Illinois
ZIP/Postal Code
46168
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 102
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 111
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 125
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 138
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 101
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 116
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 139
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 129
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 121
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 130
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 108
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 115
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 124
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 134
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 128
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 113
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19003
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 135
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 104
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 119
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 110
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 117
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 132
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 0B4
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 103
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 122
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 133
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 140
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 109
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 106
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 107
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Z 2S6
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 126
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V4X7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36125472
Citation
Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.
Results Reference
derived

Learn more about this trial

Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

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