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

January 3, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
333

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arcutis Biotherapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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