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Trial record 3 of 811 for:    Psoriasis 4

A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis. (UNVEIL)

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ClinicalTrials.gov Identifier: NCT02425826
Recruitment Status : Completed
First Posted : April 24, 2015
Results First Posted : June 6, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parapsoriasis
Interventions Drug: Apremilast
Drug: Placebo
Drug: Placebo-Apremilast
Enrollment 221
Recruitment Details Participants enrolled into this study were those with moderate plaque psoriasis without prior treatment with systemic agents or biologics and were enrolled across 25 study centers in the United States.
Pre-assignment Details Participants were randomized in a 2 to 1 ratio to receive apremilast or placebo.
Arm/Group Title Apremilast Placebo Placebo-Apremilast
Hide Arm/Group Description Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16). Participants were initially randomized to identically matching placebo (PBO) tablets twice a day (BID) during the placebo-controlled phase (Weeks 0-16) Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
Period Title: Placebo-controlled Phase (Week 0 - 16)
Started 148 73 0
Intent to Treat 147 [1] 73 [1] 0
Completed 121 [2] 64 [2] 0
Not Completed 27 9 0
Reason Not Completed
Adverse Event             5             2             0
Lack of Efficacy             0             1             0
Withdrawal by Subject             9             1             0
Lost to Follow-up             10             4             0
Other             3             1             0
[1]
ITT = includes participants who received at least one dose of study drug.
[2]
Completed = participants who completed Week 16
Period Title: Apremilast Extension Phase (Weeks 16-52)
Started 121 0 64
Received Treatment 121 0 64
Completed 86 0 50
Not Completed 35 0 14
Reason Not Completed
Adverse Event             7             0             2
Lost to Follow-up             8             0             6
Withdrawal by Subject             12             0             4
Lack of Efficacy             8             0             1
miscellaneous             0             0             1
Period Title: Post-Treatment Observational Follow-Up
Started 81 0 49
Completed 80 0 49
Not Completed 1 0 0
Arm/Group Title Placebo Apremilast Total
Hide Arm/Group Description Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16) Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16). Total of all reporting groups
Overall Number of Baseline Participants 73 148 221
Hide Baseline Analysis Population Description
The intent to treat (ITT) population consisted all participants who were randomized. Participants were included in the treatment arm which they were randomized into the ITT population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 148 participants 221 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
  82.2%
120
  81.1%
180
  81.4%
>=65 years
13
  17.8%
28
  18.9%
41
  18.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 148 participants 221 participants
51.1  (13.74) 48.6  (15.41) 49.4  (14.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 148 participants 221 participants
Female
32
  43.8%
74
  50.0%
106
  48.0%
Male
41
  56.2%
74
  50.0%
115
  52.0%
Body Surface Area (BSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent affected
Number Analyzed 73 participants 148 participants 221 participants
7.1  (1.75) 7.2  (1.61) 7.2  (1.66)
[1]
Measure Description: Body Surface Area (BSA) is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total body surface area.
Static Physician’s Global Assessment (sPGA) Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 148 participants 221 participants
1 = Almost Clear 0 0 0
2 = Mild 0 0 0
3 = Moderate 70 144 214
4 =Severe 3 3 6
5 = Very Severe 0 0 0
Missing 0 1 1
[1]
Measure Description: The Static Physician’s Global Assessment (sPGA) is the assessment by the investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema (E), induration (I), and desquamation (D) are scored on a 6-point scale, ranging from 0 (clear) to 5 (very severe), with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score.
Product of BSA and sPGA   [1] 
Mean (Standard Deviation)
Unit of measure:  Psoriasis severity index
Number Analyzed 73 participants 148 participants 221 participants
21.6  (5.87) 21.8  (5.17) 21.7  (5.40)
[1]
Measure Description: For each participant, the product of BSA and sPGA were calculated as BSA value multiplied by the sPGA score (BSA*sPGA), measured as the total psoriasis severity index. The ranges for BSA* sPGA scores were from 15 to 40% for the placebo and apremilast arms respectively. Those in the study who had a baseline BSA in the range of 5-10% and a sPGA score of 3 or 4 were enrolled. Those with a higher psoriasis severity index represented worse outcomes. The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
Duration of Psoriasis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 148 participants 221 participants
12.85  (12.350) 17.02  (14.138) 15.64  (13.684)
[1]
Measure Description: The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 148 participants 221 participants
Hispanic or Latino 4 13 17
Not Hispanic or Latino 69 134 203
Unknown 0 1 1
1.Primary Outcome
Title Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16
Hide Description BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score. The range of BSA*sPGA mean percentage change from baseline to week 16 (end of phase) were -100 to 344.4 and -100 to 100 for the placebo and apremilast groups respectively. Higher scores represented worse outcomes.
Time Frame Baseline to Week 16 (end of phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value were included. A missing value at Week 16 was imputed by last observation carried forward. (LOCF).
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 73 147
Mean (Standard Deviation)
Unit of Measure: percentage change
-10.17  (64.043) -48.07  (43.699)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -39.84
Confidence Interval (2-Sided) 95%
-54.39 to -25.30
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
Hide Description DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Time Frame Baseline to Week 16 (end of phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 71 144
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (6.62) -4.8  (5.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method ANCOVA
Comments Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-3.9 to -1.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline
Hide Description The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 6-point scale, ranging from 0 (clear) to 5 (very severe), with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are averaged and rounded to the nearest whole number to result in the final sPGA score.
Time Frame Baseline to Week 16 (end of phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized. Participants with and at least one post-baseline value are included. A missing value at Week 16 was imputed by LOCF.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 73 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.6
(4.7 to 18.5)
30.4
(23.6 to 38.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided p-value is based on the Cochran-Mantel-Haenszel test stratified by sites.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 21.0
Confidence Interval (2-Sided) 95%
11.0 to 31.1
Estimation Comments Two-sided 95% confidence intervals (CI) is based on normal approximation
4.Secondary Outcome
Title Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline
Hide Description The PtGA response rate is defined as the percentage of participants achieving 0 (clear) or 1 (very mild) on the PtGA scale at Week 16. The PtGA is the assessment by the participant of the overall disease severity at the time of evaluation. The PtGA is a 5-point scale ranging from 0 (clear) to 4 (severe).
Time Frame Baseline to Week 16 (end of phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 73 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.5
(12.9 to 31.2)
33.8
(26.7 to 41.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0365
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.
Method of Estimation Estimation Parameter Difference
Estimated Value 13.7
Confidence Interval (2-Sided) 95%
1.7 to 25.7
Estimation Comments Two-sided 95% CI is based on normal approximation
5.Secondary Outcome
Title Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)
Hide Description The Pruritus VAS assessment was conducted at the baseline visit and each post-baseline visit. The participant was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (0) represents no itch, and the right-hand boundary (100) represents itch as severe as can be imagined. The distance from the mark to the left-hand boundary will be recorded. The Pruritus VAS score ranges from 0 to 100. Higher scores correspond to more severe symptom.
Time Frame Baseline to Weeks 1 and 16 (end of phase)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 73 148
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 -9.6  (21.50) -13.9  (20.00)
Week 16 -10.2  (30.73) -19.2  (26.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments The treatment comparison was only done for Week 16; End of Phase
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method ANCOVA
Comments Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.6
Confidence Interval (2-Sided) 95%
-18.8 to -4.5
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician’s Global Assessment (ScPGA) Scale at Week 16.
Hide Description The ScPGA assessed scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment. Scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA was restricted to the participants with scalp involvement at baseline.
Time Frame Baseline to Week 16 (end of phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population with scalp psoriasis who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 55 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.2
(26.5 to 51.4)
50.0
(40.9 to 59.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0463
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments p-value was based on 2-sided CMH tests stratified by sites.
Method of Estimation Estimation Parameter Difference
Estimated Value 11.8
Confidence Interval (2-Sided) 95%
-4.0 to 27.6
Estimation Comments Two-sided 95% CI is based on normal approximation.
7.Secondary Outcome
Title Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16
Hide Description The TSQM version II is an 11-question self-administered instrument to understand a participation’s satisfaction with the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score mean indicates higher satisfaction with treatment.
Time Frame Baseline to Week 16 (end of phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed LOCF.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 73 146
Mean (Standard Deviation)
Unit of Measure: units on a scale
TSQM-Effectiveness 38.81  (25.843) 57.25  (26.484)
TSQM-Side Effects 75.00  (32.428) 78.50  (20.858)
TSQM-Convenience 65.68  (16.650) 66.93  (21.216)
TSQM-Global Satisfaction 48.74  (25.673) 63.24  (23.624)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments TSQM-Effectiveness
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Based on 2-way ANOVA with treatment and site as factors.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 17.80
Confidence Interval (2-Sided) 95%
10.36 to 25.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments TSQM - Side Effects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3433
Comments [Not Specified]
Method ANOVA
Comments Based on 2-way ANOVA with treatment and site as factors.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.00
Confidence Interval (2-Sided) 95%
-5.40 to 15.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments TSMQ-Convenience
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6250
Comments [Not Specified]
Method ANOVA
Comments Based on 2-way ANOVA with treatment and site as factors.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
-4.25 to 7.06
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments TSQM-Global Satisfaction
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.07
Confidence Interval (2-Sided) 95%
7.16 to 20.97
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52
Hide Description The TSQM version II is an 11-question self-administered instrument to understand a participants satisfaction on the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment.
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Apremilast participants who entered and were treated in the apremilast extension phase.
Arm/Group Title Placebo-Apremilast Apremilast
Hide Arm/Group Description:
Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 64 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
TSQM-Effectiveness 57.68  (26.879) 54.13  (26.898)
TSQM-Side Effects 77.29  (27.541) 75.45  (24.904)
TSQM-Convenience 72.74  (17.222) 71.76  (19.359)
TSQM-Global Satisfaction 59.24  (27.941) 59.92  (27.053)
9.Secondary Outcome
Title Mean Percentage Change From Baseline in Psoriasis Area Severity Index Score (PASI) at Week 16
Hide Description The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Time Frame Baseline to Week 16 (end of phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 73 147
Mean (Standard Deviation)
Unit of Measure: percentage change
-3.87  (79.441) -40.72  (49.523)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -37.0
Confidence Interval (2-Sided) 95%
-54.08 to -19.91
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16.
Hide Description The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Time Frame Baseline to Week 16 (end of phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 73 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.7
(16.2 to 35.6)
53.4
(45.4 to 61.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.
Method of Estimation Estimation Parameter Difference
Estimated Value 29.1
Confidence Interval (2-Sided) 95%
16.3 to 41.8
Estimation Comments Two-sided 95% CI is based on normal approximation
11.Secondary Outcome
Title Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline at Week 16
Hide Description The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Time Frame Baseline to Week 16 (end of phase)
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Hide Analysis Population Description
The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 73 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.2
(3.8 to 16.8)
21.6
(15.8 to 28.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0136
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 2-sided Cochran-Mantel-Haenszel test stratified by sites.
Method of Estimation Estimation Parameter Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
4.4 to 22.7
Estimation Comments 2-sided 95% CI is based on normal approximation.
12.Secondary Outcome
Title Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52
Hide Description BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score.
Time Frame Baseline to Week 52
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Hide Analysis Population Description
Apremilast participants who entered and were treated in the apremilast extension phase.
Arm/Group Title Placebo-Apremilast Apremilast
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Participants who were initially randomized to receive placebo were switched to apremilast 30 mg PO BID beginning at Week 16, for an additional 36 weeks (52 weeks total).
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 64 121
Mean (Standard Deviation)
Unit of Measure: percentage change
-42.23  (93.211) -55.45  (44.619)
13.Secondary Outcome
Title Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician’s Global Assessment (ScPGA) Response From Week 16 to Week 52.
Hide Description The ScPGA will assess scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment with scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA is restricted to the participants with scalp involvement at baseline.
Time Frame Week 16 to Week 52
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Hide Analysis Population Description
Participants who were initially randomized to apremilast and continued through week 52.
Arm/Group Title Apremilast
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Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.
Overall Number of Participants Analyzed 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Responder status at Week 16
50.0
(40.9 to 59.1)
Responder status maintained at Week 52
80.4
(68.2 to 88.7)
14.Secondary Outcome
Title Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Hide Description Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Time Frame From first dose of study drug to Week 16; maximum duration of exposure was 20.1 weeks during placebo controlled phase
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Hide Analysis Population Description
The safety population includes all participants who were randomized and received at least one dose of study drug.
Arm/Group Title Placebo Apremilast
Hide Arm/Group Description:
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
Overall Number of Participants Analyzed 73 147
Measure Type: Number
Unit of Measure: participants
≥ At Least 1 TEAE 35 92
≥ 1 Drug-related TEAE 21 71
≥ At Least 1 Severe TEAE 1 3
≥ At Least 1 Serious TEAE 0 3
≥ 1 Serious Drug-related TEAE 0 0
≥ 1 TEAE leading to drug withdrawal 3 5
≥ 1 TEAE Leading to drug interruption 3 9
Any TEAE leading to death 0 0
15.Secondary Outcome
Title Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
Hide Description Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Time Frame Date of first dose of apremilast during the placebo controlled phase or date of first dose of apremilast after week 16; overall maximum duration of exposure was 61.5 weeks during apremilast-exposure phase
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Hide Analysis Population Description
The safety population includes all participants who were randomized and received at least one dose of study drug; apremilast participants as treated.
Arm/Group Title Apremilast
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Participants treated with placebo initially, completed Week 16, entered and treated with apremilast during the apremilast open-label extension phase.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: participants
≥ At Least 1 TEAE 142
≥ 1 Drug-related TEAE 98
≥ At Least 1 Severe TEAE 5
≥ At Least 1 Serious TEAE 10
≥ 1 Serious Drug-related TEAE 1
≥ 1 TEAE leading to drug withdrawal 14
≥ 1 TEAE Leading to drug interruption 27
Any TEAE leading to death 0
Time Frame Adverse events are reported for the 16-week PBO-controlled and the apremilast extension phase and monitored from the date of the first dose of apremilast to 12 January2017; maximum duration of exposure was 61.5 weeks during apremilast-exposure phase.
Adverse Event Reporting Description The difference between participants enrolled (148) in the apremilast group and treated (147) lies in one participant, who was randomized in error.
 
Arm/Group Title Placebo-Controlled Phase: Apremilast (Weeks 0-16) Placebo-Controlled Phase: Placebo (Weeks 0-16) Extension Phase: APR/APR and Placebo/APR (Weeks 0-52)
Hide Arm/Group Description Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16). Participants initially randomized to identically matching placebo tablets PO BID during the placebo-controlled phase. (Weeks 0-16). Includes participants initially randomized to apremilast tablets BID in the placebo controlled phase and continued on apremilast (Apremilast/Apremilast), as well as those who were initially randomized to placebo and switched at week 16 (Placebo/Apremilast) to Apremilast 30 mg tablets BID during weeks 16-52
All-Cause Mortality
Placebo-Controlled Phase: Apremilast (Weeks 0-16) Placebo-Controlled Phase: Placebo (Weeks 0-16) Extension Phase: APR/APR and Placebo/APR (Weeks 0-52)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo-Controlled Phase: Apremilast (Weeks 0-16) Placebo-Controlled Phase: Placebo (Weeks 0-16) Extension Phase: APR/APR and Placebo/APR (Weeks 0-52)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/147 (2.04%)   0/73 (0.00%)   10/211 (4.74%) 
Hepatobiliary disorders       
Cholelithiasis  1  1/147 (0.68%)  0/73 (0.00%)  1/211 (0.47%) 
Infections and infestations       
Diverticulitis  1  0/147 (0.00%)  0/73 (0.00%)  1/211 (0.47%) 
Pneumonia  1  0/147 (0.00%)  0/73 (0.00%)  1/211 (0.47%) 
Pyelonephritis  1  1/147 (0.68%)  0/73 (0.00%)  1/211 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Invasive ductal breast carcinoma  1  0/147 (0.00%)  0/73 (0.00%)  1/211 (0.47%) 
Keratoacanthoma  1  0/147 (0.00%)  0/73 (0.00%)  1/211 (0.47%) 
Nervous system disorders       
Cerebrovascular accident  1  1/147 (0.68%)  0/73 (0.00%)  1/211 (0.47%) 
Dizziness  1  0/147 (0.00%)  0/73 (0.00%)  1/211 (0.47%) 
Psychiatric disorders       
Suicide attempt  1  0/147 (0.00%)  0/73 (0.00%)  1/211 (0.47%) 
Renal and urinary disorders       
Nephrolithiasis  1  1/147 (0.68%)  0/73 (0.00%)  1/211 (0.47%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/147 (0.00%)  0/73 (0.00%)  1/211 (0.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo-Controlled Phase: Apremilast (Weeks 0-16) Placebo-Controlled Phase: Placebo (Weeks 0-16) Extension Phase: APR/APR and Placebo/APR (Weeks 0-52)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   73/147 (49.66%)   23/73 (31.51%)   101/211 (47.87%) 
Gastrointestinal disorders       
Diarrhoea  1  43/147 (29.25%)  12/73 (16.44%)  59/211 (27.96%) 
Nausea  1  26/147 (17.69%)  7/73 (9.59%)  40/211 (18.96%) 
Vomiting  1  9/147 (6.12%)  2/73 (2.74%)  12/211 (5.69%) 
Infections and infestations       
Nasopharyngitis  1  5/147 (3.40%)  2/73 (2.74%)  22/211 (10.43%) 
Upper respiratory tract infection  1  10/147 (6.80%)  3/73 (4.11%)  15/211 (7.11%) 
Metabolism and nutrition disorders       
Decreased appetite  1  6/147 (4.08%)  4/73 (5.48%)  11/211 (5.21%) 
Nervous system disorders       
Headache  1  30/147 (20.41%)  8/73 (10.96%)  32/211 (15.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
Results Point of Contact
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Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
Phone: 1-800-260-1599
EMail: ClinicalTrialDisclosure@celgene.com
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02425826     History of Changes
Obsolete Identifiers: NCT02555826
Other Study ID Numbers: CC-10004-PSOR-012
First Submitted: April 3, 2015
First Posted: April 24, 2015
Results First Submitted: February 11, 2017
Results First Posted: June 6, 2017
Last Update Posted: December 12, 2018