Plaque Psoriasis
Conditions
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.
Interventions
Applied once daily for 12 weeks
Applied once daily for 12 weeks
DRUGVehicle Cream
Applied once daily for 12 weeks
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Roflumilast drug product will be supplied as a 0.3% and 0.15% cream. The matching vehicle cream will contain only excipients of roflumilast cream.
Intervention model description
Parallel group, double blind, vehicle-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Adult (≥18 years of age) male or female participants with chronic plaque psoriasis were recruited at 30 study sites in the US and Canada.
Participants by arm
| Arm | Count |
|---|---|
| Roflumilast Cream 0.3% Roflumilast cream 0.3% was topically applied QD for 12 weeks. | 109 |
| Roflumilast Cream 0.15% Roflumilast cream 0.15% was topically applied QD for 12 weeks. | 113 |
| Vehicle Cream Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. | 109 |
| Total | 331 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 4 | 5 |
| Overall Study | Pregnancy | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 5 | 12 |
Baseline characteristics
| Characteristic | Roflumilast Cream 0.3% | Total | Vehicle Cream | Roflumilast Cream 0.15% |
|---|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 14.11 | 53.9 years STANDARD_DEVIATION 13.99 | 55.5 years STANDARD_DEVIATION 13.49 | 54.4 years STANDARD_DEVIATION 14.2 |
| Dermatology Life Quality Index (DLQI) Score | 6.7 score on a scale STANDARD_DEVIATION 5.5 | 8.0 score on a scale STANDARD_DEVIATION 6.17 | 8.5 score on a scale STANDARD_DEVIATION 5.62 | 8.8 score on a scale STANDARD_DEVIATION 7.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 76 Participants | 25 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 255 Participants | 84 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Intertriginous Area Investigator Global Assessment (I-IGA) Score 1 - Almost Clear | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Intertriginous Area Investigator Global Assessment (I-IGA) Score 2 - Mild | 6 Participants | 25 Participants | 7 Participants | 12 Participants |
| Intertriginous Area Investigator Global Assessment (I-IGA) Score 3 - Moderate | 8 Participants | 19 Participants | 8 Participants | 3 Participants |
| Intertriginous Area Investigator Global Assessment (I-IGA) Score 4 - Severe | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Itch-Related Sleep Loss Score | 2.9 score on a scale STANDARD_DEVIATION 3.24 | 3.1 score on a scale STANDARD_DEVIATION 3.2 | 3.4 score on a scale STANDARD_DEVIATION 3.18 | 3.0 score on a scale STANDARD_DEVIATION 3.19 |
| Modified Psoriasis Area Severity Index (mPASI) Score | 5.94 score on a scale STANDARD_DEVIATION 3.959 | 6.02 score on a scale STANDARD_DEVIATION 3.956 | 5.77 score on a scale STANDARD_DEVIATION 3.498 | 6.33 score on a scale STANDARD_DEVIATION 4.363 |
| Percentage of Body Surface Area (BSA) Affected | 6.33 percentage of body surface area STANDARD_DEVIATION 4.005 | 6.40 percentage of body surface area STANDARD_DEVIATION 3.833 | 6.43 percentage of body surface area STANDARD_DEVIATION 3.597 | 6.44 percentage of body surface area STANDARD_DEVIATION 3.915 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 20 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 12 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 12 Participants | 29 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 82 Participants | 269 Participants | 92 Participants | 95 Participants |
| Sex: Female, Male Female | 53 Participants | 146 Participants | 42 Participants | 51 Participants |
| Sex: Female, Male Male | 56 Participants | 185 Participants | 67 Participants | 62 Participants |
| Total Psoriasis Symptom Diary (PSD) Score | 68.9 score on a scale STANDARD_DEVIATION 41.18 | 71.2 score on a scale STANDARD_DEVIATION 43.35 | 75.1 score on a scale STANDARD_DEVIATION 42.55 | 69.6 score on a scale STANDARD_DEVIATION 46.2 |
| Whole Body Investigator Global Assessment (IGA) Score 0 - Clear | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Whole Body Investigator Global Assessment (IGA) Score 1 - Almost Clear | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Whole Body Investigator Global Assessment (IGA) Score 2 - Mild | 17 Participants | 46 Participants | 11 Participants | 18 Participants |
| Whole Body Investigator Global Assessment (IGA) Score 3 - Moderate | 84 Participants | 256 Participants | 89 Participants | 83 Participants |
| Whole Body Investigator Global Assessment (IGA) Score 4 - Severe | 8 Participants | 29 Participants | 9 Participants | 12 Participants |
| Worst Itch - Numerical Rating Scale (WI-NRS) Score | 6.1 score on a scale STANDARD_DEVIATION 2.67 | 5.9 score on a scale STANDARD_DEVIATION 2.87 | 5.9 score on a scale STANDARD_DEVIATION 2.87 | 5.6 score on a scale STANDARD_DEVIATION 3.05 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 113 | 0 / 109 |
| other Total, other adverse events | 8 / 109 | 7 / 110 | 0 / 107 |
| serious Total, serious adverse events | 1 / 109 | 1 / 110 | 2 / 107 |
Outcome results
Primary
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at 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.
Time frame: Week 6
Population: All randomized participants are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roflumilast Cream 0.3% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6 | 28.0 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6 | 22.8 percentage of participants |
| Vehicle Cream | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6 | 8.3 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: 0.004Regression, Logistic
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: This endpoint was added in protocol amendment 1. All participants randomized after implementing amendment 1 are included. All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Cream 0.3% | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 4 | -2.2 score on a scale | Standard Deviation 3.46 |
| Roflumilast Cream 0.3% | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 6 | -2.6 score on a scale | Standard Deviation 3.64 |
| Roflumilast Cream 0.3% | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 8 | -2.6 score on a scale | Standard Deviation 3.68 |
| Roflumilast Cream 0.3% | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 12 | -2.6 score on a scale | Standard Deviation 4.48 |
| Roflumilast Cream 0.15% | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 12 | -4.2 score on a scale | Standard Deviation 4.92 |
| Roflumilast Cream 0.15% | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 4 | -2.3 score on a scale | Standard Deviation 4.01 |
| Roflumilast Cream 0.15% | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 8 | -3.5 score on a scale | Standard Deviation 4.57 |
| Roflumilast Cream 0.15% | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 6 | -3.1 score on a scale | Standard Deviation 4.23 |
| Vehicle Cream | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 12 | -1.4 score on a scale | Standard Deviation 5.28 |
| Vehicle Cream | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 6 | -1.8 score on a scale | Standard Deviation 4.23 |
| Vehicle Cream | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 8 | -1.6 score on a scale | Standard Deviation 4.77 |
| Vehicle Cream | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Week 4 | -1.9 score on a scale | Standard Deviation 4.29 |
Comparison: Difference from vehicle cream at Week 4p-value: 0.255ANCOVA
Comparison: Difference from vehicle cream on Week 4p-value: 0.687ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: 0.045ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: 0.059ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: 0.051ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: 0.013ANCOVA
Comparison: Difference from vehicle cream at Week 12p-value: 0.036ANCOVA
Comparison: Difference from vehicle cream at Week 12p-value: 0.001ANCOVA
Secondary
Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Cream 0.3% | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 4 | -1.1 score on a scale | Standard Deviation 2.95 |
| Roflumilast Cream 0.3% | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 6 | -1.5 score on a scale | Standard Deviation 2.94 |
| Roflumilast Cream 0.3% | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 8 | -1.6 score on a scale | Standard Deviation 2.96 |
| Roflumilast Cream 0.3% | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 12 | -1.8 score on a scale | Standard Deviation 3.01 |
| Roflumilast Cream 0.15% | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 12 | -1.7 score on a scale | Standard Deviation 2.66 |
| Roflumilast Cream 0.15% | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 4 | -1.2 score on a scale | Standard Deviation 2.54 |
| Roflumilast Cream 0.15% | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 8 | -1.7 score on a scale | Standard Deviation 2.75 |
| Roflumilast Cream 0.15% | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 6 | -1.3 score on a scale | Standard Deviation 2.65 |
| Vehicle Cream | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 12 | -1.1 score on a scale | Standard Deviation 3.33 |
| Vehicle Cream | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 6 | -0.9 score on a scale | Standard Deviation 2.96 |
| Vehicle Cream | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 8 | -0.9 score on a scale | Standard Deviation 3.08 |
| Vehicle Cream | Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score | Week 4 | -1.0 score on a scale | Standard Deviation 2.74 |
Comparison: Difference from vehicle cream at Week 4p-value: 0.184ANCOVA
Comparison: Difference from placebo at Week 4p-value: 0.207ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: 0.004ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: 0.022ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: 0.003ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 12p-value: 0.003ANCOVA
Comparison: Difference from vehicle cream at Week 12p-value: 0.01ANCOVA
Secondary
Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Cream 0.3% | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 12 | -59.48 score on a scale | Standard Deviation 54.881 |
| Roflumilast Cream 0.3% | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 8 | -59.09 score on a scale | Standard Deviation 49.29 |
| Roflumilast Cream 0.3% | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 4 | -40.08 score on a scale | Standard Deviation 46.811 |
| Roflumilast Cream 0.3% | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 6 | -53.15 score on a scale | Standard Deviation 46.47 |
| Roflumilast Cream 0.15% | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 6 | -59.73 score on a scale | Standard Deviation 32.409 |
| Roflumilast Cream 0.15% | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 8 | -65.12 score on a scale | Standard Deviation 31.97 |
| Roflumilast Cream 0.15% | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 12 | -68.03 score on a scale | Standard Deviation 33.021 |
| Roflumilast Cream 0.15% | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 4 | -47.32 score on a scale | Standard Deviation 29.717 |
| Vehicle Cream | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 4 | -18.01 score on a scale | Standard Deviation 46.622 |
| Vehicle Cream | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 8 | -18.47 score on a scale | Standard Deviation 63.777 |
| Vehicle Cream | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 6 | -16.42 score on a scale | Standard Deviation 58.385 |
| Vehicle Cream | Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score | Week 12 | -13.65 score on a scale | Standard Deviation 70.731 |
Comparison: Difference from vehicle cream at Week 4p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 4p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: <0.001ANOVA
Comparison: Difference from vehicle cream at Week 12p-value: <0.001Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: <0.001ANCOVA
Secondary
Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Cream 0.3% | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 4 | -32.7 percentage of participants | Standard Deviation 34.61 |
| Roflumilast Cream 0.3% | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 6 | -37.8 percentage of participants | Standard Deviation 35.71 |
| Roflumilast Cream 0.3% | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 8 | -40.5 percentage of participants | Standard Deviation 36.62 |
| Roflumilast Cream 0.3% | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 12 | -40.8 percentage of participants | Standard Deviation 41.12 |
| Roflumilast Cream 0.15% | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 12 | -43.4 percentage of participants | Standard Deviation 40.44 |
| Roflumilast Cream 0.15% | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 4 | -32.7 percentage of participants | Standard Deviation 35.08 |
| Roflumilast Cream 0.15% | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 8 | -40.1 percentage of participants | Standard Deviation 39.04 |
| Roflumilast Cream 0.15% | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 6 | -38.0 percentage of participants | Standard Deviation 37.88 |
| Vehicle Cream | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 12 | -23.0 percentage of participants | Standard Deviation 41.38 |
| Vehicle Cream | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 6 | -24.6 percentage of participants | Standard Deviation 38.15 |
| Vehicle Cream | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 8 | -26.9 percentage of participants | Standard Deviation 41.78 |
| Vehicle Cream | Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score | Week 4 | -22.9 percentage of participants | Standard Deviation 31.85 |
Comparison: Difference from vehicle cream on Week 4p-value: 0.002ANOVA
Comparison: Difference from vehicle cream at Week 4p-value: 0.002ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: <0.001ANCOVA
Comparison: Difference from placebo at Week 6p-value: <0.001ANCOVA
Comparison: Difference from placebo at Week 8p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 12p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 12p-value: <0.001ANCOVA
Secondary
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Cream 0.3% | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 6 | -3.3 score on a scale | Standard Deviation 2.56 |
| Roflumilast Cream 0.3% | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 12 | -3.4 score on a scale | Standard Deviation 2.76 |
| Roflumilast Cream 0.3% | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 8 | -3.5 score on a scale | Standard Deviation 2.59 |
| Roflumilast Cream 0.3% | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 4 | -2.8 score on a scale | Standard Deviation 2.53 |
| Roflumilast Cream 0.15% | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 8 | -2.9 score on a scale | Standard Deviation 2.73 |
| Roflumilast Cream 0.15% | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 12 | -3.2 score on a scale | Standard Deviation 2.84 |
| Roflumilast Cream 0.15% | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 6 | -2.6 score on a scale | Standard Deviation 2.73 |
| Roflumilast Cream 0.15% | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 4 | -1.9 score on a scale | Standard Deviation 2.45 |
| Vehicle Cream | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 12 | -1.3 score on a scale | Standard Deviation 2.76 |
| Vehicle Cream | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 4 | -1.1 score on a scale | Standard Deviation 2.2 |
| Vehicle Cream | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 8 | -1.5 score on a scale | Standard Deviation 3 |
| Vehicle Cream | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score | Week 6 | -1.3 score on a scale | Standard Deviation 2.67 |
Comparison: Difference from vehicle cream at Week 4p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 4p-value: 0.002ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 12p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 12p-value: <0.001ANCOVA
Secondary
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Roflumilast Cream 0.3% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 8 | 31.3 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 4 | 13.3 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 12 | 34.1 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 6 | 24.1 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 8 | 23.0 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 6 | 22.2 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 4 | 7.6 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 12 | 31.1 percentage of participants |
| Vehicle Cream | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 6 | 9.6 percentage of participants |
| Vehicle Cream | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 4 | 10.5 percentage of participants |
| Vehicle Cream | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 12 | 16.0 percentage of participants |
| Vehicle Cream | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline | Week 8 | 13.2 percentage of participants |
Comparison: Difference from vehicle cream at Week 4p-value: 0.527Regression, Logistic
Comparison: Difference from vehicle cream at Week 4p-value: 0.444Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: 0.006Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: 0.013Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.002Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.064Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: 0.002Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: 0.009Regression, Logistic
Secondary
Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Roflumilast Cream 0.3% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 4 | 6.0 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 6 | 14.3 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 8 | 16.9 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 12 | 20.6 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 12 | 13.7 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 4 | 1.3 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 8 | 7.4 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 6 | 2.3 percentage of participants |
| Vehicle Cream | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 12 | 7.8 percentage of participants |
| Vehicle Cream | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 6 | 3.2 percentage of participants |
| Vehicle Cream | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 8 | 6.0 percentage of participants |
| Vehicle Cream | Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline | Week 4 | 2.3 percentage of participants |
Comparison: Difference from vehicle cream at Week 4p-value: 0.188Regression, Logistic
Comparison: Difference from vehicle cream at Week 4p-value: 0.577Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: 0.008Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: 0.664Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.015Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.666Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: 0.009Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: 0.163Regression, Logistic
Secondary
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
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.
Time frame: Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Roflumilast Cream 0.3% | 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 | Week 12 | 94.3 percentage of participants |
| Roflumilast Cream 0.3% | 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 | Week 4 | 46.6 percentage of participants |
| Roflumilast Cream 0.3% | 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 | Week 6 | 73.4 percentage of participants |
| Roflumilast Cream 0.3% | 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 | Week 8 | 87.1 percentage of participants |
| Roflumilast Cream 0.15% | 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 | Week 4 | 43.8 percentage of participants |
| Roflumilast Cream 0.15% | 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 | Week 12 | 32.4 percentage of participants |
| Roflumilast Cream 0.15% | 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 | Week 8 | 60.9 percentage of participants |
| Roflumilast Cream 0.15% | 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 | Week 6 | 43.7 percentage of participants |
| Vehicle Cream | 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 | Week 6 | 29.4 percentage of participants |
| Vehicle Cream | 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 | Week 12 | 24.3 percentage of participants |
| Vehicle Cream | 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 | Week 4 | 17.6 percentage of participants |
| Vehicle Cream | 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 | Week 8 | 36.1 percentage of participants |
Comparison: Difference form vehicle cream at Week 4p-value: 0.086Regression, Logistic
Comparison: Difference from vehicle cream at Week 4p-value: 0.123Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: 0.017Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: 0.415Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.007Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.175Regression, Linear
Comparison: Difference from vehicle at Week 12p-value: 0.001Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: 0.619Regression, Logistic
Secondary
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
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.
Time frame: Weeks 4, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or last observation carried forward (LOCF) \[subjects with assessments only before the missing assessment\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Roflumilast Cream 0.3% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | Week 12 | 37.5 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | Week 8 | 37.9 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | Week 4 | 14.5 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | Week 8 | 30.6 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | Week 4 | 9.0 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | Week 12 | 32.1 percentage of participants |
| Vehicle Cream | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | Week 4 | 4.4 percentage of participants |
| Vehicle Cream | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | Week 12 | 16.3 percentage of participants |
| Vehicle Cream | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | Week 8 | 11.9 percentage of participants |
Comparison: Difference from vehicle cream at Week 4p-value: 0.015Regression, Logistic
Comparison: Difference from placebo at Week 4p-value: 0.174Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: <0.001Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.001Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: <0.001Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: 0.008Regression, Logistic
Secondary
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Roflumilast Cream 0.3% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 4 | 10.0 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 6 | 23.9 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 8 | 32.2 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 12 | 31.3 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 12 | 27.4 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 4 | 6.9 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 8 | 24.5 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 6 | 17.4 percentage of participants |
| Vehicle Cream | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 12 | 13.6 percentage of participants |
| Vehicle Cream | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 6 | 8.0 percentage of participants |
| Vehicle Cream | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 8 | 9.8 percentage of participants |
| Vehicle Cream | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline | Week 4 | 4.4 percentage of participants |
Comparison: Difference from vehicle cream at Week 4p-value: 0.116Regression, Logistic
Comparison: Difference from vehicle cream at Week 4p-value: 0.423Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: 0.002Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: 0.038Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: <0.001Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.005Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: 0.002Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: 0.013Regression, Logistic
Secondary
Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: All randomized participants with a WI-NRS score ≥6 at baseline are included. All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Roflumilast Cream 0.3% | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 4 | 50.9 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 6 | 52.8 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 8 | 64.6 percentage of participants |
| Roflumilast Cream 0.3% | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 12 | 62.8 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 12 | 70.1 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 8 | 58.2 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 6 | 57.0 percentage of participants |
| Roflumilast Cream 0.15% | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 4 | 35.4 percentage of participants |
| Vehicle Cream | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 8 | 42.3 percentage of participants |
| Vehicle Cream | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 6 | 34.5 percentage of participants |
| Vehicle Cream | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 12 | 32.9 percentage of participants |
| Vehicle Cream | Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction | Week 4 | 24.9 percentage of participants |
Comparison: Difference from vehicle cream at Week 4p-value: 0.002Regression, Logistic
Comparison: Difference from vehicle cream at Week 4p-value: 0.203ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: 0.034Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: 0.012Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.01Regression, Logistic
Comparison: Difference from vehicle cream at Week 8p-value: 0.075Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: <0.001Regression, Logistic
Comparison: Difference from vehicle cream at Week 12p-value: <0.001Regression, Logistic
Secondary
Percent Change From Baseline in Body Surface Area (BSA) Affected
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.
Time frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Cream 0.3% | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 12 | -48.56 percentage of change | Standard Deviation 46.077 |
| Roflumilast Cream 0.3% | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 8 | -41.58 percentage of change | Standard Deviation 42.816 |
| Roflumilast Cream 0.3% | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 6 | -34.88 percentage of change | Standard Deviation 39.53 |
| Roflumilast Cream 0.3% | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 4 | -21.74 percentage of change | Standard Deviation 34.381 |
| Roflumilast Cream 0.15% | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 12 | -47.50 percentage of change | Standard Deviation 36.304 |
| Roflumilast Cream 0.15% | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 6 | -33.41 percentage of change | Standard Deviation 32.136 |
| Roflumilast Cream 0.15% | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 8 | -40.49 percentage of change | Standard Deviation 34.379 |
| Roflumilast Cream 0.15% | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 4 | -23.25 percentage of change | Standard Deviation 27.084 |
| Vehicle Cream | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 6 | -8.19 percentage of change | Standard Deviation 40.989 |
| Vehicle Cream | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 12 | -6.74 percentage of change | Standard Deviation 51.469 |
| Vehicle Cream | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 4 | -5.33 percentage of change | Standard Deviation 31.834 |
| Vehicle Cream | Percent Change From Baseline in Body Surface Area (BSA) Affected | Week 8 | -7.40 percentage of change | Standard Deviation 52.859 |
Comparison: Difference from vehicle cream on Week 4p-value: <0.001Regression, Logistic
Comparison: Difference from vehicle cream at Week 4p-value: <0.001Regression, Logistic
Comparison: Difference from vehicle cream at Week 6p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 6p-value: <0.001ANCOVA
Comparison: Difference from vehicle at Week 8p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 8p-value: <0.001ANCOVA
Comparison: Difference from vehicle at Week 12p-value: <0.001ANCOVA
Comparison: Difference from vehicle cream at Week 12p-value: <0.001ANCOVA
Secondary
Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
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.
Time frame: Weeks 4, 6, 8, and 12
Population: All randomized participants are included. Missing data from subjects was handled with linear interpolation (subjects with assessments before and after the missing assessment) or LOCF (subjects with assessments only before the missing assessment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roflumilast Cream 0.3% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 6: Itching | 2.7 score on a scale | Standard Deviation 2.7 |
| Roflumilast Cream 0.3% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 4: Itching | 3.0 score on a scale | Standard Deviation 2.87 |
| Roflumilast Cream 0.3% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 6: Pain | 1.5 score on a scale | Standard Deviation 2.39 |
| Roflumilast Cream 0.3% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 12: Pain | 1.2 score on a scale | Standard Deviation 2.37 |
| Roflumilast Cream 0.3% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 4: Pain | 1.8 score on a scale | Standard Deviation 2.67 |
| Roflumilast Cream 0.3% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 8: Itching | 2.4 score on a scale | Standard Deviation 2.7 |
| Roflumilast Cream 0.3% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 12: Itching | 2.3 score on a scale | Standard Deviation 2.78 |
| Roflumilast Cream 0.3% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 8: Pain | 1.3 score on a scale | Standard Deviation 2.48 |
| Roflumilast Cream 0.15% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 4: Pain | 1.6 score on a scale | Standard Deviation 2.46 |
| Roflumilast Cream 0.15% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 8: Pain | 1.3 score on a scale | Standard Deviation 2.36 |
| Roflumilast Cream 0.15% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 4: Itching | 3.3 score on a scale | Standard Deviation 2.88 |
| Roflumilast Cream 0.15% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 12: Itching | 2.2 score on a scale | Standard Deviation 2.65 |
| Roflumilast Cream 0.15% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 12: Pain | 1.2 score on a scale | Standard Deviation 2.35 |
| Roflumilast Cream 0.15% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 6: Itching | 2.8 score on a scale | Standard Deviation 2.8 |
| Roflumilast Cream 0.15% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 6: Pain | 1.5 score on a scale | Standard Deviation 2.52 |
| Roflumilast Cream 0.15% | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 8: Itching | 2.4 score on a scale | Standard Deviation 2.69 |
| Vehicle Cream | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 6: Pain | 2.3 score on a scale | Standard Deviation 2.7 |
| Vehicle Cream | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 4: Itching | 4.2 score on a scale | Standard Deviation 3.02 |
| Vehicle Cream | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 4: Pain | 2.6 score on a scale | Standard Deviation 2.89 |
| Vehicle Cream | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 6: Itching | 4.2 score on a scale | Standard Deviation 2.96 |
| Vehicle Cream | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 12: Pain | 2.5 score on a scale | Standard Deviation 2.94 |
| Vehicle Cream | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 8: Itching | 4.0 score on a scale | Standard Deviation 2.92 |
| Vehicle Cream | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 8: Pain | 2.4 score on a scale | Standard Deviation 2.76 |
| Vehicle Cream | Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) | Week 12: Itching | 4.3 score on a scale | Standard Deviation 3.14 |