Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (DERMIS-2)
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| ClinicalTrials.gov Identifier: NCT04211389 |
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Recruitment Status :
Completed
First Posted : December 26, 2019
Last Update Posted : December 20, 2021
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Sponsor:
Arcutis Biotherapeutics, Inc.
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 439 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 |
| Actual Primary Completion Date : | November 23, 2020 |
| Actual Study Completion Date : | November 23, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: ARQ-151 cream 0.3%
Active comparator
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Drug: ARQ-151 0.3% cream
ARQ-151 0.3% cream |
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Placebo Comparator: ARQ-151 cream vehicle
Placebo comparator
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Drug: ARQ-151 vehicle cream
ARQ-151 vehicle cream |
Primary Outcome Measures :
- 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 :
- 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)
- 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
- 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.
- 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.
- 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)
- 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)
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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:
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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
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
Locations
Show 39 study locations
Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
Investigators
| Study Director: | David Berk, MD | Arcutis Biotherapeutics, Inc. |
| 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: | December 20, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |