Palmoplantaris Pustulosis
Conditions
Keywords
Palmoplantar Pustulosis, CC-10004, Apremilast, Only Japanese, Efficacy, Safety, Phase 2
Brief summary
This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations. The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.
Interventions
DRUGApremilast
Apremilast
DRUGPlacebo
Placebo
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject has a diagnosis of Palmoplantar Pustulosis with or without pustulotic arthro-osteitis (PAO) for at least 24 weeks before screening. 2. Subject has a total score of PPPASI: ≥ 12 at screening and baseline. 3. Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity score: ≥ 2) at screening and baseline. 4. Subject has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations prior to or at screening.
Exclusion criteria
The presence of any of the following will exclude a subject from enrollment: 1. Subject has a diagnosis of plaque-type psoriasis. 2. Subject has the presence of pustular psoriasis in any part of the body other than the palms and soles. 3. Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement during the screening). 4. Subject has received any procedures for focal infection (e.g, tonsillectomy and dental therapy) within 24 weeks of baseline. 5. Subject has periodontitis obviously requiring treatment at screening. 6. Subject has chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment for a month or more at screening. 7. Subject has evidence of skin conditions of hands and feet that would interfere with evaluations of the effect of study medication. 8. Subject is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve a PPPASI-50 at Week 16 | At Week 16 | PPPASI-50 is defined as \>= 50 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Weeks 2 to 16 | PPPASI-75 is defined as \>=75 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Missing values were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder. |
| Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16 | Baseline to Week 16 | The AUC for PPPASI total score from baseline through Week 16 is the sum of the AUCs in each time interval specified by the dates of the visits and is calculated based on the linear trapezoidal method. PPPASI is a disease-specific efficacy assessment tool to evaluate 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. |
| Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Baseline to Week 16 | PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. A positive change from baseline indicates a worsening of symptoms. |
| Change From Baseline in PPPASI Total Score at Week 16 | Baseline and Week 16 | PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Change from baseline based on a mixed-effects model for repeated measures with a positive change indicating a worsening of symptoms. |
| AUC for PPSI Total Score From Baseline Through Week 16 | Baseline to Week 16 | The AUC for PPSI total score from baseline through Week 16 is the sum of the AUCs in each time interval specified by the dates of the visits and is calculated based on the linear trapezoidal method. PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. |
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Weeks 2 to 14 | PPPASI-50 is defined as \>= 50 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Missing values at were imputed using non-responder imputation (NRI) as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder. |
| Change From Baseline in PPSI Total Score at Week 16 | Baseline and Week 16 | PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. Change from baseline based on a mixed-effects model for repeated measures with a positive change indicating a worsening of symptoms. |
| Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Weeks 2 to 16 | The PGA for palms and soles was used to determine the participants PPP lesions on palms and soles. Lesions on palms and soles were graded based on the following scales: 0 = Clear 1. = Almost clear/Minimal 2. = Mild 3. = Moderate 4. = Severe 5. = Very severe. The percentage of of participants with a post baseline score of 0 or 1 (responders) are reported. Missing values at were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder. |
| Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Weeks 2 to 16 | The PGA for palms and soles was used to determine the participants PPP lesions on palms and soles. Lesions on palms and soles were graded based on the following scales: 0 = Clear 1. = Almost clear/Minimal 2. = Mild 3. = Moderate 4. = Severe 5. = Very severe. The percentage of of participants with at least a 2 grade improvement from baseline (stringent responders) are reported. issing values at were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder. |
| Change From Baseline in Participant VAS Assessment for PPP Symptoms | Baseline and Weeks 2,4,6,8,12,16 | Participants assessed the degree of both pruritus itching and skin discomfort/pain as symptoms on hands and feet caused by PPP on a VAS. Each score ranged from 0 to 100. The left-hand boundary (0) on the VAS represents no itch/pain and the right-hand boundary (100) represents itch/pain as severe as can be imagined by participant. |
| Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Baseline to Week 16 | PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. A positive change from baseline indicates a worsening of symptoms. |
Countries
Japan
Participant flow
Recruitment details
Japanese participants with palmoplantar pustulosis (PPP) were enrolled at 22 research centers in Japan from October 2019 to June 2021.
Pre-assignment details
Participants were randomized in a 1:1 ratio to receive either apremilast or matched placebo from Week 0 to Week 16 (placebo-controlled phase) of the study. Eligible participants then entered an active-treatment phase and received apremilast from after Week 16 to Week 32.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Then Apremilast 30mg BID Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32). | 44 |
| Apremilast 30 mg BID Then Apremilast 30 mg BID Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32). | 46 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Active-treatment Phase | Physician Decision | 0 | 1 |
| Active-treatment Phase | Pregnancy | 0 | 1 |
| Active-treatment Phase | Withdrawal by Subject | 1 | 0 |
| Placebo-controlled Phase | Adverse Event | 3 | 0 |
Baseline characteristics
| Characteristic | Apremilast 30 mg BID Then Apremilast 30 mg BID | Total | Placebo Then Apremilast 30mg BID |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 11.3 | 54.8 years STANDARD_DEVIATION 11.42 | 54.7 years STANDARD_DEVIATION 11.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 90 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Palmo-plantar Pustulosis Area and Severity Index (PPPASI) Score | 25.03 Score on a scale STANDARD_DEVIATION 8.675 | 24.98 Score on a scale STANDARD_DEVIATION 8.744 | 24.93 Score on a scale STANDARD_DEVIATION 8.915 |
| Palmo-plantar Severity Index (PPSI) Total Score | 8.3 Score on a Scale STANDARD_DEVIATION 1.48 | 8.20 Score on a Scale STANDARD_DEVIATION 1.48 | 8.2 Score on a Scale STANDARD_DEVIATION 1.49 |
| Participants Visual Analogue Scale (VAS) Assessment for PPP Symptoms Discomfort/Pain | 45.4 Score on a Scale STANDARD_DEVIATION 31.92 | 47.8 Score on a Scale STANDARD_DEVIATION 30.93 | 50.3 Score on a Scale STANDARD_DEVIATION 29.98 |
| Participants Visual Analogue Scale (VAS) Assessment for PPP Symptoms Itching | 50.3 Score on a Scale STANDARD_DEVIATION 31.58 | 53.5 Score on a Scale STANDARD_DEVIATION 29.85 | 57.0 Score on a Scale STANDARD_DEVIATION 27.8 |
| Physician's Global Assessment (PGA) Score for Palms and Soles 0 = Clear | 0 Participants | 0 Participants | 0 Participants |
| Physician's Global Assessment (PGA) Score for Palms and Soles 1 = Almost clear/Minimal | 0 Participants | 0 Participants | 0 Participants |
| Physician's Global Assessment (PGA) Score for Palms and Soles 2 = Mild | 3 Participants | 4 Participants | 1 Participants |
| Physician's Global Assessment (PGA) Score for Palms and Soles 3 = Moderate | 16 Participants | 40 Participants | 24 Participants |
| Physician's Global Assessment (PGA) Score for Palms and Soles 4 = Severe | 21 Participants | 38 Participants | 17 Participants |
| Physician's Global Assessment (PGA) Score for Palms and Soles 5 = Very severe | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 46 Participants | 90 Participants | 44 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 36 Participants | 69 Participants | 33 Participants |
| Sex: Female, Male Male | 10 Participants | 21 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 46 | 0 / 87 |
| other Total, other adverse events | 16 / 44 | 32 / 46 | 40 / 87 |
| serious Total, serious adverse events | 0 / 44 | 0 / 46 | 3 / 87 |
Outcome results
Primary
Percentage of Participants Who Achieve a PPPASI-50 at Week 16
PPPASI-50 is defined as \>= 50 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease.
Time frame: At Week 16
Population: Intent-to-treat (ITT) population which includes all randomized participants who received at least one dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-50 at Week 16 | 40.9 Percentage of Partcipants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-50 at Week 16 | 78.3 Percentage of Partcipants |
p-value: 0.000395% CI: [18.6, 56.1]Chi-squared
Secondary
Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16
The AUC for PPPASI total score from baseline through Week 16 is the sum of the AUCs in each time interval specified by the dates of the visits and is calculated based on the linear trapezoidal method. PPPASI is a disease-specific efficacy assessment tool to evaluate 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease.
Time frame: Baseline to Week 16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo-controlled Phase - Placebo | Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16 | 1911.74 Scores * Day |
| Placebo-controlled Phase - Apremilast 30 mg BID | Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16 | 1337.49 Scores * Day |
Secondary
AUC for PPSI Total Score From Baseline Through Week 16
The AUC for PPSI total score from baseline through Week 16 is the sum of the AUCs in each time interval specified by the dates of the visits and is calculated based on the linear trapezoidal method. PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease.
Time frame: Baseline to Week 16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo-controlled Phase - Placebo | AUC for PPSI Total Score From Baseline Through Week 16 | 725.62 Scores * Day |
| Placebo-controlled Phase - Apremilast 30 mg BID | AUC for PPSI Total Score From Baseline Through Week 16 | 564.63 Scores * Day |
Secondary
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Participants assessed the degree of both pruritus itching and skin discomfort/pain as symptoms on hands and feet caused by PPP on a VAS. Each score ranged from 0 to 100. The left-hand boundary (0) on the VAS represents no itch/pain and the right-hand boundary (100) represents itch/pain as severe as can be imagined by participant.
Time frame: Baseline and Weeks 2,4,6,8,12,16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 2 | -2.4 Units on scale | Standard Deviation 25.07 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 4 | -7.9 Units on scale | Standard Deviation 21.39 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 6 | -9.3 Units on scale | Standard Deviation 29.65 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 8 | -19.0 Units on scale | Standard Deviation 25.53 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 12 | -14.9 Units on scale | Standard Deviation 35.82 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 16 | -10.5 Units on scale | Standard Deviation 30.81 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 2 | -0.7 Units on scale | Standard Deviation 32.47 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 4 | -6.9 Units on scale | Standard Deviation 30.39 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 6 | -6.7 Units on scale | Standard Deviation 28.8 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 8 | -15.5 Units on scale | Standard Deviation 31.14 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 12 | -14.1 Units on scale | Standard Deviation 32.07 |
| Placebo-controlled Phase - Placebo | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 16 | -13.5 Units on scale | Standard Deviation 27.51 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 12 | -27.6 Units on scale | Standard Deviation 28.14 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 2 | -25.0 Units on scale | Standard Deviation 24.42 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 2 | -20.2 Units on scale | Standard Deviation 26.73 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 4 | -22.7 Units on scale | Standard Deviation 26.36 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 8 | -22.0 Units on scale | Standard Deviation 29.02 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 6 | -22.4 Units on scale | Standard Deviation 29.37 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 4 | -21.6 Units on scale | Standard Deviation 29.21 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 8 | -24.8 Units on scale | Standard Deviation 29.38 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 16 | -25.3 Units on scale | Standard Deviation 29.51 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 12 | -28.3 Units on scale | Standard Deviation 28.55 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Discomfort/Pain Week 6 | -22.4 Units on scale | Standard Deviation 33.16 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Itching Week 16 | -26.8 Units on scale | Standard Deviation 28.65 |
Secondary
Change From Baseline in PPPASI Total Score at Week 16
PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Change from baseline based on a mixed-effects model for repeated measures with a positive change indicating a worsening of symptoms.
Time frame: Baseline and Week 16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Phase - Placebo | Change From Baseline in PPPASI Total Score at Week 16 | -11.03 Units on a scale | Standard Error 1.26 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in PPPASI Total Score at Week 16 | -16.48 Units on a scale | Standard Error 1.224 |
Secondary
Change From Baseline in PPSI Total Score at Week 16
PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. Change from baseline based on a mixed-effects model for repeated measures with a positive change indicating a worsening of symptoms.
Time frame: Baseline and Week 16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Phase - Placebo | Change From Baseline in PPSI Total Score at Week 16 | -2.56 Units on a scale | Standard Error 0.303 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Change From Baseline in PPSI Total Score at Week 16 | -4.19 Units on a scale | Standard Error 0.293 |
Secondary
Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase.
The PGA for palms and soles was used to determine the participants PPP lesions on palms and soles. Lesions on palms and soles were graded based on the following scales: 0 = Clear 1. = Almost clear/Minimal 2. = Mild 3. = Moderate 4. = Severe 5. = Very severe. The percentage of of participants with at least a 2 grade improvement from baseline (stringent responders) are reported. issing values at were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder.
Time frame: Weeks 2 to 16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with a PGA greater than 1 at baseline are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 2 | 0.0 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 4 | 2.3 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 6 | 2.3 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 8 | 9.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 10 | 9.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 12 | 9.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 14 | 9.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 16 | 4.5 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 16 | 17.4 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 2 | 2.2 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 10 | 10.9 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 4 | 4.3 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 14 | 17.4 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 6 | 4.3 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 12 | 15.2 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | Week 8 | 6.5 Percentage of Participants |
Secondary
Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase
The PGA for palms and soles was used to determine the participants PPP lesions on palms and soles. Lesions on palms and soles were graded based on the following scales: 0 = Clear 1. = Almost clear/Minimal 2. = Mild 3. = Moderate 4. = Severe 5. = Very severe. The percentage of of participants with a post baseline score of 0 or 1 (responders) are reported. Missing values at were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder.
Time frame: Weeks 2 to 16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with a PGA greater than 1 at baseline are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 2 | 0.0 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 4 | 2.3 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 6 | 2.3 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 8 | 9.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 10 | 9.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 12 | 9.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 14 | 9.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 16 | 4.5 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 16 | 19.6 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 2 | 2.2 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 10 | 13.0 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 4 | 4.3 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 14 | 17.4 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 6 | 4.3 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 12 | 15.2 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Week 8 | 8.7 Percentage of Participants |
Secondary
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
PPPASI-50 is defined as \>= 50 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Missing values at were imputed using non-responder imputation (NRI) as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder.
Time frame: Weeks 2 to 14
Population: ITT population which includes all randomized participants who received at least one dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 6 | 18.2 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 2 | 2.3 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 4 | 18.2 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 8 | 43.2 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 10 | 34.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 12 | 34.1 Percentage of Participants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 14 | 47.7 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 14 | 73.9 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 8 | 65.2 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 12 | 69.6 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 2 | 30.4 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 10 | 71.7 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 4 | 52.2 Percentage of Participants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Week 6 | 69.6 Percentage of Participants |
Secondary
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
PPPASI-75 is defined as \>=75 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Missing values were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder.
Time frame: Weeks 2 to 16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 14 | 13.6 Percentage of Partcipants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 2 | 2.3 Percentage of Partcipants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 8 | 11.4 Percentage of Partcipants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 16 | 15.9 Percentage of Partcipants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 10 | 11.4 Percentage of Partcipants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 4 | 4.5 Percentage of Partcipants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 12 | 13.6 Percentage of Partcipants |
| Placebo-controlled Phase - Placebo | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 6 | 9.1 Percentage of Partcipants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 12 | 30.4 Percentage of Partcipants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 14 | 37.0 Percentage of Partcipants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 16 | 43.5 Percentage of Partcipants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 2 | 2.2 Percentage of Partcipants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 4 | 10.9 Percentage of Partcipants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 6 | 21.7 Percentage of Partcipants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 8 | 19.6 Percentage of Partcipants |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Week 10 | 30.4 Percentage of Partcipants |
Secondary
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. A positive change from baseline indicates a worsening of symptoms.
Time frame: Baseline to Week 16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 2 | -11.09 Percent Change | Standard Deviation 22.102 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 4 | -23.82 Percent Change | Standard Deviation 28.307 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 6 | -30.15 Percent Change | Standard Deviation 24.826 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 8 | -42.41 Percent Change | Standard Deviation 27.115 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 10 | -36.52 Percent Change | Standard Deviation 32.999 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 12 | -42.30 Percent Change | Standard Deviation 26.802 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 14 | -45.00 Percent Change | Standard Deviation 30.915 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 16 | -42.35 Percent Change | Standard Deviation 32.671 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 16 | -64.33 Percent Change | Standard Deviation 24.345 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 2 | -36.62 Percent Change | Standard Deviation 22.816 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 10 | -60.85 Percent Change | Standard Deviation 21.792 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 4 | -48.96 Percent Change | Standard Deviation 21.973 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 14 | -63.78 Percent Change | Standard Deviation 23.952 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 6 | -55.06 Percent Change | Standard Deviation 23.164 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 12 | -61.22 Percent Change | Standard Deviation 22.787 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Week 8 | -57.11 Percent Change | Standard Deviation 22.71 |
Secondary
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. A positive change from baseline indicates a worsening of symptoms.
Time frame: Baseline to Week 16
Population: ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 2 | -6.25 Percent Change | Standard Deviation 19.409 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 4 | -13.84 Percent Change | Standard Deviation 25.629 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 6 | -20.02 Percent Change | Standard Deviation 20.639 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 8 | -30.12 Percent Change | Standard Deviation 29.34 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 10 | -27.42 Percent Change | Standard Deviation 29.635 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 12 | -31.18 Percent Change | Standard Deviation 27.817 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 14 | -34.98 Percent Change | Standard Deviation 28.205 |
| Placebo-controlled Phase - Placebo | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 16 | -30.90 Percent Change | Standard Deviation 25.414 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 16 | -48.96 Percent Change | Standard Deviation 21.821 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 2 | -24.70 Percent Change | Standard Deviation 19.78 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 10 | -44.22 Percent Change | Standard Deviation 24.89 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 4 | -34.58 Percent Change | Standard Deviation 23.19 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 14 | -50.16 Percent Change | Standard Deviation 25.488 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 6 | -40.50 Percent Change | Standard Deviation 23.035 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 12 | -46.47 Percent Change | Standard Deviation 25.202 |
| Placebo-controlled Phase - Apremilast 30 mg BID | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Week 8 | -40.76 Percent Change | Standard Deviation 23.019 |