| 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. | All randomized participants are included. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of ARQ-151 cream) was applied topically QD for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00028.0
- OG00122.8
- OG0028.3
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Regression, Logistic | Logistic regression with a factor of treatment group and a covariate of baseline IGA score. | <0.001 | | | | | | | | | | | | | | Superiority | Missing data imputed using linear interpolation and last observation carried forward (LOCF) where linear interpolation was not computationally possible. | | |
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| 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. | 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]. | Posted | | Number | | percentage of participants | | Weeks 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% |
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| 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. | 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). | Posted | | Mean | Standard Deviation | percentage of change | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Number | | percentage of participants | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Number | | percentage of participants | | Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Number | | percentage of participants | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Number | | percentage of participants | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Number | | percentage of participants | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | percentage of participants | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) and Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 4, 6, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Roflumilast Cream 0.3% | Roflumilast cream 0.3% was topically applied QD for 12 weeks. | | OG001 | Roflumilast Cream 0.15% | Roflumilast cream 0.15% was topically applied QD for 12 weeks. | | OG002 | Vehicle Cream | Vehicle cream matched to roflumilast cream (containing only excipients of active cream) was applied topically QD for 12 weeks. |
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