The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- Registration Number
- NCT03638258
- Lead Sponsor
- Arcutis Biotherapeutics, Inc.
- Brief Summary
This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 331
- Participants legally competent to sign and give informed consent
- Males and females ages 18 years and older (inclusive)
- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
- Females of childbearing potential (FOCBP) must have a negative urine 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 are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with roflumilast cream 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 study medication.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Roflumilast Cream 0.3% Roflumilast Cream 0.3% Roflumilast cream 0.3% topically applied QD for 12 weeks. Roflumilast Cream 0.15% Roflumilast Cream 0.15% Roflumilast cream 0.15% topically applied QD for 12 weeks. Vehicle Cream Vehicle Cream Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6 Week 6 The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Weeks 4, 8, and 12 The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score Baseline (Day 1) and Weeks 4, 6, 8, and 12 The percent change from baseline in mPASI score is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. For scoring, the body is divided into four sections (head \[h\]: 10% of a person's skin; arms \[a\] 20%; trunk \[t\] 30%; legs (l\] 40%); for each section, the percent of area involved is estimated from 0 (0% involved) to 6 (90 to 100% involved). Then, within each area, the severity is estimated by three clinical signs: erythema ('E'; redness), induration ('T'; thickness), and desquamation ('S'; scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum severity possible. Each of these areas is scored by itself, and then the four scores are combined into the final mPASI, using the formula mPASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 0.4 (El + Tl + Sl) Al.
Percent Change From Baseline in Body Surface Area (BSA) Affected Baseline (Day 1) and Weeks 4, 6, 8, and 12 The BSA affected by psoriasis was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. The mean percent change from baseline in BSA is presented.
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline Baseline (Day 1) and Weeks 4, 6, 8, and 12 The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') plus a 2-grade improvement from baseline is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline Weeks 4, 6, 8, and 12 The percentage of participants (who had intertriginous area involvement with an I-IGA score of at least mild at baseline) with at least a 2-grade improvement in I-IGA score at Weeks 4, 6, 8, and 12 is presented.
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score Baseline (Day 1) and Weeks 4, 6, 8, and 12 The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean (SD) change in WI-NRS score from baseline is presented.
Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction Baseline (Day 1) and Weeks 4, 6, 8, and 12 The percentage of participants who had baseline WI-NRS scores ≥6 who achieved a 4-point reduction in WI-NRS score at Weeks 4, 6, 8, and 12 is reported. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours.
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline Baseline (Day 1) and Weeks 4, 6, 8, and 12 The percentage of subjects achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline Baseline (Day 1) and Weeks 4, 6, 8, and 12 The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. The percentage of subjects achieving a 90% reduction in mPASI (eg, mPASI-90) score relative to baseline is presented.
Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score Baseline (Day 1) and Weeks 4, 6, 8, and 12 The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 11 ("worst imaginable symptoms"). Scores range from 0 to 176, with higher scores indicating greater symptom severity. The mean (SD) change in PSD total score relative to baseline is presented for each treatment arm.
Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score Baseline (Day 1) and Weeks 4, 6, 8, and 12 The Itch-Related Sleep Loss NRS is a single item scale scored from 0 ("no itch-related sleep loss") to 10 ("itch-related sleep loss as bad as it could be") assessing the severity of itch-related sleep loss in the past 24 hours. The mean (SD) change from the baseline NRS score is presented for each treatment arm.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score Baseline (Day 1) and Weeks 4, 6, 8, and 12 The DLQI is a 10-item scale asking subject to rate the severity of symptoms during the past week. Each item is scored from 0 ("not at all" or "not relevant") to 3 or 4 ("very much") \[2 questions are scored 0 to 3 and 8 questions are scored 0 to 4\]. The total DLQI score ranges from 0 to 48, with higher scores indicating greater symptom severity. The mean (SD) change from baseline DLQI score is presented.
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) Weeks 4, 6, 8, and 12 Two items from the PSD asking participants to rate the overall severity of psoriasis-related itching and pain during the past 24 hours are presented. Each item is scored on an 11-point scale ranging from 0 ("no symptom") to 10 ("worst imaginable symptom"), with lower scores indicating lower symptoms severity. The mean (SD) score is presented for each treatment arm.
Trial Locations
- Locations (30)
Arcutis Clinical Site 12
🇺🇸Miami, Florida, United States
Arcutis Clinical Site 26
🇨🇦Markham, Ontario, Canada
Arcutis Clinical Site 21
🇺🇸Louisville, Kentucky, United States
Arcutis Clinical Site 34
🇺🇸Clinton Township, Michigan, United States
Arcutis Clinical Site 10
🇨🇦Ajax, Ontario, Canada
Arcutis Clinical Site 13
🇺🇸Houston, Texas, United States
Arcutis Clinical Site 28
🇺🇸San Diego, California, United States
Arcutis Clinical Site 16
🇺🇸Sanford, Florida, United States
Arcutis Clinical Site 36
🇨🇦Windsor, Ontario, Canada
Arcutis Clinical Site 35
🇺🇸Beverly Hills, California, United States
Arcutis Clinical Site 29
🇺🇸Northridge, California, United States
Arcutis Clinical Site 15
🇺🇸Pittsburgh, Pennsylvania, United States
Arcutis Clinical Site 19
🇺🇸College Station, Texas, United States
Arcutis Clinical Site 17
🇨🇦Peterborough, Ontario, Canada
Arcutis Clinical Site 18
🇨🇦Surrey, British Columbia, Canada
Arcutis Clinical Site 39
🇺🇸Bexley, Ohio, United States
Arcutis Clinical Site 33
🇺🇸Detroit, Michigan, United States
Arcutis Clinical Site 22
🇺🇸New York, New York, United States
Arcutis Clinical Site 20
🇺🇸Fridley, Minnesota, United States
Arcutis Clinical Site 11
🇨🇦Surrey, British Columbia, Canada
Arcutis Clinical Site 25
🇨🇦London, Ontario, Canada
Arcutis Clinical Site 32
🇨🇦Oakville, Ontario, Canada
Arcutis Clinical Site 30
🇨🇦Waterloo, Ontario, Canada
Arcutis Clinical Site 27
🇺🇸Santa Monica, California, United States
Arcutis Clinical Site 31
🇺🇸Norfolk, Virginia, United States
Arcutis Clinical Site 24
🇺🇸Webster, Texas, United States
Arcutis Clinical Site 37
🇺🇸Houston, Texas, United States
Arcutis Clinical Site 23
🇺🇸San Antonio, Texas, United States
Arcutis Clinical Site 14
🇺🇸High Point, North Carolina, United States
Arcutis Clinical Site 38
🇨🇦Winnipeg, Manitoba, Canada