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

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ClinicalTrials.gov Identifier: NCT04211389
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: ARQ-151 0.3% cream Drug: ARQ-151 vehicle cream Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ARQ-151 cream 0.3%
Active comparator
 Drug: ARQ-151 0.3% cream
ARQ-151 0.3% cream
Placebo Comparator: ARQ-151 cream vehicle
Placebo comparator
 Drug: ARQ-151 vehicle cream
ARQ-151 vehicle cream


Outcome Measures
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Primary Outcome Measures :
  1. Investigator Global Assessment Scale (IGA) Score Change [ Time Frame: Week 8 ]
    Achievement of an IGA score of 'clear' or 'almost clear' plus a 2-grade improvement from Baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).


Secondary Outcome Measures :
  1. Achievement of Psoriasis Area Severity Index 75 (PASI-75) [ Time Frame: Week 8 ]
    Psoriasis Area and Severity Index (PASI) is the most widely used tool 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 0 (no disease) to 72 (maximal disease)

  2. Intertriginous IGA (I-IGA) score of 'clear' or 'almost clear' PLUS a 2-grade improvement [ Time Frame: Week 8 ]
    For subjects with intertriginous area involvement, and with severity of the intertriginous lesions at least 'mild' (intertriginous IGA (I-IGA) ≥2) at Baseline, achievement of 'I-IGA' score of 'clear' or 'almost clear' PLUS a 2-grade improvement

  3. Reduction in Worst Itch (WI-NRS) pruritus score [ Time Frame: Week 2, Week 4, Week 8 ]
    In subjects with WI-NRS pruritus score ≥ 4 at baseline, achievement of a 4-point reduction in WI-NRS pruritus score. The WI-NRS is a 10 point scale with 0 as no itch and 10 as the worst itch imaginable.

  4. Change in Psoriasis Symptoms Diary (PSD) score [ Time Frame: Week 4, Week 8 ]
    The Psoriasis Symptoms Diary (PSD) evaluates subject psoriasis-related symptoms and experiences over the past 24-hours. Item scores range from 0 to 10, with higher scores indicating a worse condition.

  5. Achieving Psoriasis Area Severity Index-50 (PASI-50) [ Time Frame: Week 2, Week 4, Week 8 ]
    Psoriasis Area and Severity Index (PASI) is the most widely used tool 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 0 (no disease) to 72 (maximal disease)

  6. Achievement of Psoriasis Area Severity Index-90 (PASI-90) [ Time Frame: Week 8 ]
    Psoriasis Area and Severity Index (PASI) is the most widely used tool 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 0 (no disease) to 72 (maximal disease)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211389


Contacts
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Contact: David Berk, MD 805-418-5006 ext 5 studyinquiry@arcutis.com

Locations
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Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
Investigators
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Study Director: David Berk, MD Arcutis Biotherapeutics, Inc.
More Information
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Responsible Party: Arcutis Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04211389    
Other Study ID Numbers: ARQ-151-302
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases