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Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (DERMIS-OLE)

Primary Purpose

Chronic Plaque Psoriasis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Topical roflumilast
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 - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
  • Males and females ages 2 years and older (inclusive)

  • Subjects with chronic plaque psoriasis who meet eligibility criteria and:

    1. Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
    2. Are naïve to treatment with ARQ-151 cream (Cohort 2)
  • Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.

Exclusion Criteria:

  • Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.
  • 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.
  • 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 239
  • Arcutis Biotherapeutics Clinical Site 127
  • Arcutis Biotherapeutics Clinical Site 225
  • Arcutis Biotherapeutics Clinical Site 509
  • Arcutis Biotherapeutics Clinical Site 112
  • Arcutis Biotherapeutics Clinical Site 508
  • Arcutis Biotherapeutics Clinical Site 511
  • Arcutis Biotherapeutics Clinical Site 220
  • Arcutis Biotherapeutics Clinical Site 136
  • Arcutis Biotherapeutics Clinical Site 208
  • Arcutis Biotherapeutics Clinical Site 223
  • Arcutis Biotherapeutics Clinical Site 118
  • Arcutis Biotherapeutics Clinical Site 202
  • Arcutis Biotherapeutics Clinical Site 228
  • Arcutis Biotherapeutics Clinical Site 131
  • Arcutis Biotherapeutics Clinical Site 201
  • Arcutis Biotherapeutics Clinical Site 137
  • Arcutis Biotherapeutics Clinical Site 105
  • Arcutis Biotherapeutics Clinical Site 209
  • Arcutis Clinical Site 602
  • Arcutis Biotherapeutics Clinical Site 114
  • Arcutis Biotherapeutics Clinical Site 102
  • Arcutis Biotherapeutics Clinical Site 214
  • Arcutis Biotherapeutics Clinical Site 217
  • Arcutis Biotherapeutics Clinical Site 111
  • Arcutis Biotherapeutics Clinical Site 211
  • Arcutis Biotherapeutics Clinical Site 213
  • Arcutis Biotherapeutics Clinical Site 224
  • Arcutis Biotherapeutics Clinical Site 125
  • Arcutis Biotherapeutics Clinical Site 138
  • Arcutis Biotherapeutics Clinical Site 101
  • Arcutis Biotherapeutics Clinical Site 116
  • Arcutis Biotherapeutics Clinical Site 216
  • Arcutis Biotherapeutics Clinical Site 227
  • Arcutis Biotherapeutics Clinical Site 219
  • Arcutis Biotherapeutics Clinical Site 231
  • Arcutis Biotherapeutics Clinical Site 139
  • Arcutis Biotherapeutics Clinical Site 240
  • Arcutis Biotherapeutics Clinical Site 236
  • Arcutis Biotherapeutics Clinical Site 129
  • Arcutis Biotherapeutics Clinical Site 121
  • Arcutis Biotherapeutics Clinical Site 130
  • Arcutis Biotherapeutics Clinical Site 108
  • Arcutis Biotherapeutics Clinical Site 124
  • Arcutis Biotherapeutics Clinical Site 222
  • Arcutis Biotherapeutics Clinical Site 134
  • Arcutis Biotherapeutics Clinical Site 128
  • Arcutis Biotherapeutics Clinical Site 233
  • Arcutis Biotherapeutics Clinical Site 221
  • Arcutis Biotherapeutics Clinical Site 206
  • Arcutis Biotherapeutics Clinical Site 104
  • Arcutis Biotherapeutics Clinical Site 119
  • Arcutis Biotherapeutics Clinical Site 519
  • Arcutis Biotherapeutics Clinical Site 238
  • Arcutis Biotherapeutics Clinical Site 110
  • Arcutis Biotherapeutics Clinical Site 117
  • Arcutis Biotherapeutics Clinical Site 132
  • 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 103
  • Arcutis Biotherapeutics Clinical Site 133
  • Arcutis Biotherapeutics Clinical Site 140
  • Arcutis Biotherapeutics Clinical Site 109
  • Arcutis Biotherapeutics Clinical Site 235
  • Arcutis Biotherapeutics Clinical Site 106
  • Arcutis Biotherapeutics Clinical Site 126
  • Arcutis Clinical Site 601

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARQ-151 Cream 0.3%

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of treatment emergent AEs (TEAEs)
The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs

Secondary Outcome Measures

Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time.
In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response).
Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time
Achievement of a 75% reduction in PASI over time
Achievement of a 90% reduction in PASI over time
Achievement of a 100% reduction in PASI over time
Change in Worst Itch Numeric Rating Scale) WI-NRS score over time

Full Information

First Posted
February 25, 2020
Last Updated
September 11, 2023
Sponsor
Arcutis Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04286607
Brief Title
Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Acronym
DERMIS-OLE
Official Title
A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Subjects With Chronic Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
January 26, 2024 (Anticipated)
Study Completion Date
January 26, 2024 (Anticipated)

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 applied once a day for 24 weeks by subjects with chronic plaque psoriasis
Detailed Description
This is an open-label study in which ARQ-151 cream is applied once daily x 24 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARQ-151 Cream 0.3%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Topical roflumilast
Other Intervention Name(s)
ARQ-151 Cream 0.3%
Intervention Description
Active treatment
Primary Outcome Measure Information:
Title
Occurrence of treatment emergent AEs (TEAEs)
Description
The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time.
Time Frame
24 weeks
Title
In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response).
Time Frame
24 weeks
Title
Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time
Time Frame
24 weeks
Title
Achievement of a 75% reduction in PASI over time
Time Frame
24 weeks
Title
Achievement of a 90% reduction in PASI over time
Time Frame
24 weeks
Title
Achievement of a 100% reduction in PASI over time
Time Frame
24 weeks
Title
Change in Worst Itch Numeric Rating Scale) WI-NRS score over time
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws Males and females ages 2 years and older (inclusive) Subjects with chronic plaque psoriasis who meet eligibility criteria and: Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or Are naïve to treatment with ARQ-151 cream (Cohort 2) Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial. Exclusion Criteria: Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study. 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. 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 239
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
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 225
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 509
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
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 508
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 511
City
Rancho Santa Margarita
State/Province
California
ZIP/Postal Code
92688
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 136
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
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 223
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
91436
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 202
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
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 131
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
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 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 209
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Arcutis Clinical Site 602
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
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 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 111
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
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 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 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 139
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
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 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 124
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
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 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 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 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 519
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
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 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 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 103
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
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 235
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N2
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 126
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V4X7
Country
Canada
Facility Name
Arcutis Clinical Site 601
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

Learn more about this trial

Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

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