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Completed

NCT Number: NCT04286607

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

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Key information

Conditions

Chronic Plaque Psoriasis

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arcutis Biotherapeutics Clinical Site 132, Calgary, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical roflumilast

Drug

Active treatment

Other names: ARQ-151 Cream 0.3%

Primary outcomes

  1. Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 24 weeks

    The percentage of participants with ≥TEAE is reported.

  2. Percentage of Participants With ≥1 Serious Adverse Events (SAEs)

    Time frame: Up to 24 weeks

    The percentage of participants with ≥1 SAE is reported.

Secondary outcomes

  1. Achievement of an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Over Time

    Time frame: Weeks 4, 12, and 24

    The percentage of participants achieving an IGA score of 0 or 1 is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.

  2. Duration of Response (DOR) for Participants Achieving an IGA Score of 'Clear' or 'Almost Clear'

    Time frame: Up to Week 30

    The Kaplan-Meier (KM) median DOR (days) of IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The duration of response starts with the first assessment of clear or almost clear, which could be as early as the Week 2 assessment in the feeder study, and continues until the participant's disease worsens or completes their involvement in the study. Therefore, the time variable could be as long as 30 weeks, 6 weeks in the feeder study plus 24 weeks in the ARQ-151-306 study.

  3. Return to IGA Score of ≥2 After Achieving an IGA Score of 'Clear' or 'Almost Clear'

    Time frame: Up to Week 24

    The percentage of participants worsening to IGA Score of ≥2 after achieving an IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.

  4. Achievement of a 50% Reduction in Psoriasis Area Severity Index (PASI-50) Score Over Time

    Time frame: Weeks 4, 12, and 24

    The percentage of participants achieving PASI-50 is reported. The 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.

  5. Achievement of a 75% Reduction in Psoriasis Area Severity Index (PASI-75) Score Over Time

    Time frame: Weeks 4, 12, and 24

    The percentage of participants achieving PASI-75 is reported. The 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.

  6. Achievement of a 90% Reduction in Psoriasis Area Severity Index (PASI-90) Score Over Time

    Time frame: Weeks 4, 12, and 24

    The percentage of participants achieving PASI-90 is reported. The 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.

  7. Achievement of a 100% Reduction in Psoriasis Area Severity Index (PASI-100) Score Over Time

    Time frame: Weeks 4, 12, and 24

    The percentage of participants achieving PASI-100 is reported. The 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.

  8. Achievement of Success in Worst Itch Numeric Rating Scale (WI-NRS) Score Over Time

    Time frame: Weeks 4, 12, and 24

    The percentage of participants achieving WI-NRS success is reported. WI-NRS "success" is defined as a ≥4 point improvement from a baseline score of ≥4. The WI-NRS is a simple, single item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the past 24 hours. Higher scores indicate greater symptom severity.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Arcutis Biotherapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: DERMIS-OLE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2020
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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