search
Back to results

Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (DERMIS-2)

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ARQ-151 0.3% cream
ARQ-151 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 consented 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 203
  • Arcutis Biotherapeutics Clinical Site 239
  • Arcutis Biotherapeutics Clinical Site 225
  • Arcutis Biotherapeutics Clinical Site 220
  • Arcutis Biotherapeutics Clinical Site 208
  • Arcutis Biotherapeutics Clinical Site 215
  • Arcutis Biotherapeutics Clinical Site 223
  • Arcutis Biotherapeutics Clinical Site 237
  • Arcutis Biotherapeutics Clinical Site 228
  • Arcutis Biotherapeutics Clinical Site 201
  • Arcutis Biotherapeutics Clinical Site 209
  • Arcutis Biotherapeutics Clinical Site 214
  • Arcutis Biotherapeutics Clinical Site 217
  • Arcutis Biotherapeutics Clinical Site 211
  • Arcutis Biotherapeutics Clinical Site 213
  • Arcutis Biotherapeutics Clinical Site 224
  • Arcutis Biotherapeutics Clinical Site 212
  • Arcutis Biotherapeutics Clinical Site 216
  • Arcutis Biotherapeutics Clinical Site 227
  • Arcutis Biotherapeutics Clinical Site 219
  • Arcutis Biotherapeutics Clinical Site 231
  • Arcutis Biotherapeutics Clinical Site 240
  • Arcutis Biotherapeutics Clinical Site 236
  • Arcutis Biotherapeutics Clinical Site 222
  • Arcutis Biotherapeutics Clinical Site 229
  • Arcutis Biotherapeutics Clinical Site 233
  • Arcutis Biotherapeutics Clinical Site 221
  • Arcutis Biotherapeutics Clinical Site 206
  • Arcutis Biotherapeutics Clinical Site 238
  • Arcutis Biotherapeutics Clinical Site 210
  • Arcutis Biotherapeutics Clinical Site 230
  • Arcutis Biotherapeutics Clinical Site 207
  • Arcutis Biotherapeutics Clinical Site 226
  • Arcutis Biotherapeutics Clinical Site 232
  • Arcutis Biotherapeutics Clinical Site 234
  • Arcutis Biotherapeutics Clinical Site 205
  • Arcutis Biotherapeutics Clinical Site 218
  • Arcutis Biotherapeutics Clinical Site 235
  • Arcutis Biotherapeutics Clinical Site 204

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ARQ-151 cream 0.3%

ARQ-151 cream vehicle

Arm Description

Active comparator

Placebo comparator

Outcomes

Primary Outcome Measures

Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented 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 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. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.

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. Participants are included whether they achieved PASI-50 or not.
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)
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-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 Success in Intertriginous Investigator Global Assessment (I-IGA) Scale Assessment of Disease Severity at Week 8
The number of participants with I-IGA score ≥2 at baseline 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 I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline I-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.
Number of Participants Achieving I-IGA Score of 'Clear' 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 intertriginous area plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score
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') the participant experienced in the past 24 hours, 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.
search

1. Study Identification

Unique Protocol Identification Number
NCT04211389
Brief Title
Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Acronym
DERMIS-2
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 17, 2019 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
November 23, 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 study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis
Detailed Description
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis

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
442 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARQ-151 cream 0.3%
Arm Type
Active Comparator
Arm Description
Active comparator
Arm Title
ARQ-151 cream vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
ARQ-151 0.3% cream
Intervention Description
ARQ-151 0.3% cream
Intervention Type
Drug
Intervention Name(s)
ARQ-151 vehicle cream
Intervention Description
ARQ-151 vehicle cream
Primary Outcome Measure Information:
Title
Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale
Description
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented 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 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. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Time Frame
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. Participants are included whether they achieved PASI-50 or not.
Time Frame
From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 124 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
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-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 Success in Intertriginous Investigator Global Assessment (I-IGA) Scale Assessment of Disease Severity at Week 8
Description
The number of participants with I-IGA score ≥2 at baseline 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 I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline I-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
Week 8
Title
Number of Participants Achieving I-IGA Score of 'Clear' 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 intertriginous area plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Time Frame
Week 8
Title
Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score
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') the participant experienced in the past 24 hours, with higher scores indicating greater symptoms severity. Results are based on observed data only.
Time Frame
Baseline (Day 1) and Week 2, Week 4, Week 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
Baseline (Day 1) and 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 consented 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
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 Biotherapeutics Clinical Site 203
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 239
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 225
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 220
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 208
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 215
City
Santa Monica
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 223
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
91436
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 237
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 228
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 201
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 209
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 214
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 217
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 211
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 213
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 224
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 212
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 216
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 227
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 219
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 231
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 240
City
Reno
State/Province
Nevada
ZIP/Postal Code
89703
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 236
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 222
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 229
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 233
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 221
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 206
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 238
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 210
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 230
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 207
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 226
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V0C6
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 232
City
Winnepeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 234
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 205
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 218
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 235
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N2
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 204
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
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

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

We'll reach out to this number within 24 hrs