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

March 5, 2024 updated by: Arcutis Biotherapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis

Study Type

Interventional

Enrollment (Actual)

333

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 0B4
        • Arcutis Biotherapeutics Clinical Site 132
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Arcutis Biotherapeutics Clinical Site 207
      • Surrey, British Columbia, Canada, V3V0C6
        • Arcutis Biotherapeutics Clinical Site 226
    • Manitoba
      • Winnepeg, Manitoba, Canada, R3M 3Z4
        • Arcutis Biotherapeutics Clinical Site 232
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Arcutis Biotherapeutics Clinical Site 234
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • Arcutis Biotherapeutics Clinical Site 205
      • Barrie, Ontario, Canada, L4M 7G1
        • Arcutis Biotherapeutics Clinical Site 218
      • London, Ontario, Canada, N6H 5L5
        • Arcutis Biotherapeutics Clinical Site 103
      • Mississauga, Ontario, Canada, L5H 1G9
        • Arcutis Biotherapeutics Clinical Site 133
      • Ottawa, Ontario, Canada, K2C 3N2
        • Arcutis Biotherapeutics Clinical Site 140
      • Peterborough, Ontario, Canada, K9J 5K2
        • Arcutis Biotherapeutics Clinical Site 109
      • Toronto, Ontario, Canada, M4W 2N2
        • Arcutis Biotherapeutics Clinical Site 235
      • Waterloo, Ontario, Canada, N2J 1C4
        • Arcutis Biotherapeutics Clinical Site 106
      • Windsor, Ontario, Canada, N8W 1E6
        • Arcutis Biotherapeutics Clinical Site 204
    • Quebec
      • Montreal, Quebec, Canada, H3Z 2S6
        • Arcutis Biotherapeutics Clinical Site 107
      • Québec, Quebec, Canada, G1V4X7
        • Arcutis Biotherapeutics Clinical Site 126
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Arcutis Clinical Site 601
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Arcutis Biotherapeutics Clinical Site 203
    • California
      • Beverly Hills, California, United States, 90212
        • Arcutis Biotherapeutics Clinical Site 239
      • Encinitas, California, United States, 92024
        • Arcutis Biotherapeutics Clinical Site 127
      • Encino, California, United States, 91436
        • Arcutis Biotherapeutics Clinical Site 225
      • Fountain Valley, California, United States, 92708
        • Arcutis Biotherapeutics Clinical Site 509
      • Fremont, California, United States, 94538
        • Arcutis Biotherapeutics Clinical Site 112
      • Irvine, California, United States, 92697
        • Arcutis Biotherapeutics Clinical Site 120
      • Los Angeles, California, United States, 90057
        • Arcutis Biotherapeutics Clinical Site 508
      • Rancho Santa Margarita, California, United States, 92688
        • Arcutis Biotherapeutics Clinical Site 511
      • San Diego, California, United States, 92123
        • Arcutis Biotherapeutics Clinical Site 220
      • San Diego, California, United States, 92123
        • Arcutis Biotherapeutics Clinical Site 123
      • San Francisco, California, United States, 94132
        • Arcutis Biotherapeutics Clinical Site 136
      • Santa Monica, California, United States, 90404
        • Arcutis Biotherapeutics Clinical Site 208
      • Santa Monica, California, United States, 90503
        • Arcutis Biotherapeutics Clinical Site 215
    • Florida
      • Boynton Beach, Florida, United States, 91436
        • Arcutis Biotherapeutics Clinical Site 223
      • DeLand, Florida, United States, 32720
        • Arcutis Biotherapeutics Clinical Site 237
      • Delray Beach, Florida, United States, 33484
        • Arcutis Biotherapeutics Clinical Site 118
      • Hialeah, Florida, United States, 33016
        • Arcutis Biotherapeutics Clinical Site 202
      • Largo, Florida, United States, 33770
        • Arcutis Biotherapeutics Clinical Site 228
      • Miami, Florida, United States, 33174
        • Arcutis Biotherapeutics Clinical Site 131
      • North Miami Beach, Florida, United States, 33162
        • Arcutis Biotherapeutics Clinical Site 201
      • Ocala, Florida, United States, 34470
        • Arcutis Biotherapeutics Clinical Site 137
      • Sanford, Florida, United States, 32771
        • Arcutis Biotherapeutics Clinical Site 105
      • Sweetwater, Florida, United States, 33172
        • Arcutis Biotherapeutics Clinical Site 209
    • Idaho
      • Boise, Idaho, United States, 83706
        • Arcutis Clinical Site 602
    • Illinois
      • Plainfield, Illinois, United States, 46168
        • Arcutis Biotherapeutics Clinical Site 114
      • Rolling Meadows, Illinois, United States, 60008
        • Arcutis Biotherapeutics Clinical Site 102
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Arcutis Biotherapeutics Clinical Site 214
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Arcutis Biotherapeutics Clinical Site 217
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Arcutis Biotherapeutics Clinical Site 111
      • Lake Charles, Louisiana, United States, 70605
        • Arcutis Biotherapeutics Clinical Site 211
      • Metairie, Louisiana, United States, 70006
        • Arcutis Biotherapeutics Clinical Site 213
      • New Orleans, Louisiana, United States, 70115
        • Arcutis Biotherapeutics Clinical Site 224
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Arcutis Biotherapeutics Clinical Site 125
      • Rockville, Maryland, United States, 20850
        • Arcutis Biotherapeutics Clinical Site 138
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Arcutis Biotherapeutics Clinical Site 101
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Arcutis Biotherapeutics Clinical Site 116
      • Detroit, Michigan, United States, 48202
        • Arcutis Biotherapeutics Clinical Site 212
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Arcutis Biotherapeutics Clinical Site 216
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Arcutis Biotherapeutics Clinical Site 227
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Arcutis Biotherapeutics Clinical Site 219
      • Las Vegas, Nevada, United States, 89148
        • Arcutis Biotherapeutics Clinical Site 231
      • Reno, Nevada, United States, 89703
        • Arcutis Biotherapeutics Clinical Site 240
      • Reno, Nevada, United States, 89509
        • Arcutis Biotherapeutics Clinical Site 139
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Arcutis Biotherapeutics Clinical Site 236
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Arcutis Biotherapeutics Clinical Site 129
    • New York
      • New York, New York, United States, 10029
        • Arcutis Biotherapeutics Clinical Site 121
      • Rochester, New York, United States, 14623
        • Arcutis Biotherapeutics Clinical Site 130
      • Stony Brook, New York, United States, 11790
        • Arcutis Biotherapeutics Clinical Site 108
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Arcutis Biotherapeutics Clinical Site 115
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Arcutis Biotherapeutics Clinical Site 124
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Arcutis Biotherapeutics Clinical Site 222
      • Oklahoma City, Oklahoma, United States, 73118
        • Arcutis Biotherapeutics Clinical Site 134
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • Arcutis Biotherapeutics Clinical Site 229
      • Duncansville, Pennsylvania, United States, 16635
        • Arcutis Biotherapeutics Clinical Site 128
      • Exton, Pennsylvania, United States, 19003
        • Arcutis Biotherapeutics Clinical Site 113
      • Pittsburgh, Pennsylvania, United States, 15213
        • Arcutis Biotherapeutics Clinical Site 135
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Arcutis Biotherapeutics Clinical Site 233
      • Murfreesboro, Tennessee, United States, 37130
        • Arcutis Biotherapeutics Clinical Site 221
    • Texas
      • Arlington, Texas, United States, 76011
        • Arcutis Biotherapeutics Clinical Site 206
      • College Station, Texas, United States, 77845
        • Arcutis Biotherapeutics Clinical Site 104
      • Dallas, Texas, United States, 75246
        • Arcutis Biotherapeutics Clinical Site 119
      • Frisco, Texas, United States, 75034
        • Arcutis Biotherapeutics Clinical Site 519
      • Houston, Texas, United States, 77030
        • Arcutis Biotherapeutics Clinical Site 238
      • San Antonio, Texas, United States, 78218
        • Arcutis Biotherapeutics Clinical Site 110
      • San Antonio, Texas, United States, 78229
        • Arcutis Biotherapeutics Clinical Site 117
    • Utah
      • West Jordan, Utah, United States, 84088
        • Arcutis Biotherapeutics Clinical Site 210
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Arcutis Biotherapeutics Clinical Site 230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARQ-151 Cream 0.3%
Drug: Topical roflumilast
Active treatment
Other Names:
  • ARQ-151 Cream 0.3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of treatment emergent AEs (TEAEs)
Time Frame: 24 weeks
The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time.
Time Frame: 24 weeks
24 weeks
In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response).
Time Frame: 24 weeks
24 weeks
Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time
Time Frame: 24 weeks
24 weeks
Achievement of a 75% reduction in PASI over time
Time Frame: 24 weeks
24 weeks
Achievement of a 90% reduction in PASI over time
Time Frame: 24 weeks
24 weeks
Achievement of a 100% reduction in PASI over time
Time Frame: 24 weeks
24 weeks
Change in Worst Itch Numeric Rating Scale) WI-NRS score over time
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcutis Biotherapeutics, Inc.

Investigators

  • Study Director: David Berk, MD, Arcutis Biotherapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2020

Primary Completion (Actual)

January 22, 2024

Study Completion (Actual)

January 22, 2024

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARQ-151-306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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