Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis (NCT NCT04057937)
NCT ID: NCT04057937
Last Updated: 2024-07-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
At Week 16
Results posted on
2024-07-17
Participant Flow
Japanese participants with palmoplantar pustulosis (PPP) were enrolled at 22 research centers in Japan from October 2019 to June 2021.
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.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Placebo-controlled Phase
STARTED
|
44
|
46
|
|
Placebo-controlled Phase
COMPLETED
|
41
|
46
|
|
Placebo-controlled Phase
NOT COMPLETED
|
3
|
0
|
|
Active-treatment Phase
STARTED
|
41
|
46
|
|
Active-treatment Phase
COMPLETED
|
40
|
44
|
|
Active-treatment Phase
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Placebo-controlled Phase
Adverse Event
|
3
|
0
|
|
Active-treatment Phase
Withdrawal by Subject
|
1
|
0
|
|
Active-treatment Phase
Pregnancy
|
0
|
1
|
|
Active-treatment Phase
Physician Decision
|
0
|
1
|
Baseline Characteristics
VAS assessment was missed by 2 participants in the placebo arm at baseline.
Baseline characteristics by cohort
| Measure |
Placebo Then Apremilast 30mg BID
n=44 Participants
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).
|
Apremilast 30 mg BID Then Apremilast 30 mg BID
n=46 Participants
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).
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 11.68 • n=44 Participants
|
54.9 years
STANDARD_DEVIATION 11.30 • n=46 Participants
|
54.8 years
STANDARD_DEVIATION 11.42 • n=90 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=44 Participants
|
36 Participants
n=46 Participants
|
69 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=44 Participants
|
10 Participants
n=46 Participants
|
21 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=44 Participants
|
46 Participants
n=46 Participants
|
90 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=44 Participants
|
46 Participants
n=46 Participants
|
90 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Palmo-plantar Pustulosis Area and Severity Index (PPPASI) Score
|
24.93 Score on a scale
STANDARD_DEVIATION 8.915 • n=44 Participants
|
25.03 Score on a scale
STANDARD_DEVIATION 8.675 • n=46 Participants
|
24.98 Score on a scale
STANDARD_DEVIATION 8.744 • n=90 Participants
|
|
Palmo-plantar Severity Index (PPSI) Total Score
|
8.2 Score on a Scale
STANDARD_DEVIATION 1.49 • n=44 Participants
|
8.3 Score on a Scale
STANDARD_DEVIATION 1.48 • n=46 Participants
|
8.20 Score on a Scale
STANDARD_DEVIATION 1.48 • n=90 Participants
|
|
Physician's Global Assessment (PGA) Score for Palms and Soles
0 = Clear
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Physician's Global Assessment (PGA) Score for Palms and Soles
1 = Almost clear/Minimal
|
0 Participants
n=44 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=90 Participants
|
|
Physician's Global Assessment (PGA) Score for Palms and Soles
2 = Mild
|
1 Participants
n=44 Participants
|
3 Participants
n=46 Participants
|
4 Participants
n=90 Participants
|
|
Physician's Global Assessment (PGA) Score for Palms and Soles
3 = Moderate
|
24 Participants
n=44 Participants
|
16 Participants
n=46 Participants
|
40 Participants
n=90 Participants
|
|
Physician's Global Assessment (PGA) Score for Palms and Soles
4 = Severe
|
17 Participants
n=44 Participants
|
21 Participants
n=46 Participants
|
38 Participants
n=90 Participants
|
|
Physician's Global Assessment (PGA) Score for Palms and Soles
5 = Very severe
|
2 Participants
n=44 Participants
|
6 Participants
n=46 Participants
|
8 Participants
n=90 Participants
|
|
Participants Visual Analogue Scale (VAS) Assessment for PPP Symptoms
Itching
|
57.0 Score on a Scale
STANDARD_DEVIATION 27.8 • n=42 Participants • VAS assessment was missed by 2 participants in the placebo arm at baseline.
|
50.3 Score on a Scale
STANDARD_DEVIATION 31.58 • n=46 Participants • VAS assessment was missed by 2 participants in the placebo arm at baseline.
|
53.5 Score on a Scale
STANDARD_DEVIATION 29.85 • n=88 Participants • VAS assessment was missed by 2 participants in the placebo arm at baseline.
|
|
Participants Visual Analogue Scale (VAS) Assessment for PPP Symptoms
Discomfort/Pain
|
50.3 Score on a Scale
STANDARD_DEVIATION 29.98 • n=42 Participants • VAS assessment was missed by 2 participants in the placebo arm at baseline.
|
45.4 Score on a Scale
STANDARD_DEVIATION 31.92 • n=46 Participants • VAS assessment was missed by 2 participants in the placebo arm at baseline.
|
47.8 Score on a Scale
STANDARD_DEVIATION 30.93 • n=88 Participants • VAS assessment was missed by 2 participants in the placebo arm at baseline.
|
PRIMARY outcome
Timeframe: At Week 16Population: Intent-to-treat (ITT) population which includes all randomized participants who received at least one dose of investigational product.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=44 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
Percentage of Participants Who Achieve a PPPASI-50 at Week 16
|
40.9 Percentage of Partcipants
|
78.3 Percentage of Partcipants
|
SECONDARY outcome
Timeframe: Weeks 2 to 14Population: ITT population which includes all randomized participants who received at least one dose of investigational product.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=44 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
Week 2
|
2.3 Percentage of Participants
|
30.4 Percentage of Participants
|
|
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
Week 6
|
18.2 Percentage of Participants
|
69.6 Percentage of Participants
|
|
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
Week 8
|
43.2 Percentage of Participants
|
65.2 Percentage of Participants
|
|
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
Week 4
|
18.2 Percentage of Participants
|
52.2 Percentage of Participants
|
|
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
Week 10
|
34.1 Percentage of Participants
|
71.7 Percentage of Participants
|
|
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
Week 12
|
34.1 Percentage of Participants
|
69.6 Percentage of Participants
|
|
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
Week 14
|
47.7 Percentage of Participants
|
73.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 2 to 16Population: ITT population which includes all randomized participants who received at least one dose of investigational product.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=44 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
Week 4
|
4.5 Percentage of Partcipants
|
10.9 Percentage of Partcipants
|
|
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
Week 6
|
9.1 Percentage of Partcipants
|
21.7 Percentage of Partcipants
|
|
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
Week 8
|
11.4 Percentage of Partcipants
|
19.6 Percentage of Partcipants
|
|
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
Week 12
|
13.6 Percentage of Partcipants
|
30.4 Percentage of Partcipants
|
|
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
Week 2
|
2.3 Percentage of Partcipants
|
2.2 Percentage of Partcipants
|
|
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
Week 10
|
11.4 Percentage of Partcipants
|
30.4 Percentage of Partcipants
|
|
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
Week 14
|
13.6 Percentage of Partcipants
|
37.0 Percentage of Partcipants
|
|
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
Week 16
|
15.9 Percentage of Partcipants
|
43.5 Percentage of Partcipants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: ITT population which includes all randomized participants who received at least one dose of investigational product.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=44 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16
|
1911.74 Scores * Day
Interval 1707.92 to 2115.57
|
1337.49 Scores * Day
Interval 1134.52 to 1540.47
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: 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.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=44 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
Week 2
|
-11.09 Percent Change
Standard Deviation 22.102
|
-36.62 Percent Change
Standard Deviation 22.816
|
|
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
Week 8
|
-42.41 Percent Change
Standard Deviation 27.115
|
-57.11 Percent Change
Standard Deviation 22.710
|
|
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
Week 10
|
-36.52 Percent Change
Standard Deviation 32.999
|
-60.85 Percent Change
Standard Deviation 21.792
|
|
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
Week 12
|
-42.30 Percent Change
Standard Deviation 26.802
|
-61.22 Percent Change
Standard Deviation 22.787
|
|
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
Week 14
|
-45.00 Percent Change
Standard Deviation 30.915
|
-63.78 Percent Change
Standard Deviation 23.952
|
|
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
Week 4
|
-23.82 Percent Change
Standard Deviation 28.307
|
-48.96 Percent Change
Standard Deviation 21.973
|
|
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
Week 6
|
-30.15 Percent Change
Standard Deviation 24.826
|
-55.06 Percent Change
Standard Deviation 23.164
|
|
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
Week 16
|
-42.35 Percent Change
Standard Deviation 32.671
|
-64.33 Percent Change
Standard Deviation 24.345
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: 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.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=41 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
Change From Baseline in PPPASI Total Score at Week 16
|
-11.03 Units on a scale
Standard Error 1.260
|
-16.48 Units on a scale
Standard Error 1.224
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: ITT population which includes all randomized participants who received at least one dose of investigational product.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=44 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
AUC for PPSI Total Score From Baseline Through Week 16
|
725.62 Scores * Day
Interval 668.09 to 783.15
|
564.63 Scores * Day
Interval 507.35 to 621.9
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: 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.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=44 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
Week 4
|
-13.84 Percent Change
Standard Deviation 25.629
|
-34.58 Percent Change
Standard Deviation 23.190
|
|
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
Week 6
|
-20.02 Percent Change
Standard Deviation 20.639
|
-40.50 Percent Change
Standard Deviation 23.035
|
|
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
Week 10
|
-27.42 Percent Change
Standard Deviation 29.635
|
-44.22 Percent Change
Standard Deviation 24.890
|
|
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
Week 2
|
-6.25 Percent Change
Standard Deviation 19.409
|
-24.70 Percent Change
Standard Deviation 19.780
|
|
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
Week 8
|
-30.12 Percent Change
Standard Deviation 29.340
|
-40.76 Percent Change
Standard Deviation 23.019
|
|
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
Week 12
|
-31.18 Percent Change
Standard Deviation 27.817
|
-46.47 Percent Change
Standard Deviation 25.202
|
|
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
Week 14
|
-34.98 Percent Change
Standard Deviation 28.205
|
-50.16 Percent Change
Standard Deviation 25.488
|
|
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
Week 16
|
-30.90 Percent Change
Standard Deviation 25.414
|
-48.96 Percent Change
Standard Deviation 21.821
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: 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.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=41 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
Change From Baseline in PPSI Total Score at Week 16
|
-2.56 Units on a scale
Standard Error 0.303
|
-4.19 Units on a scale
Standard Error 0.293
|
SECONDARY outcome
Timeframe: Weeks 2 to 16Population: 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.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=44 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
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
|
2.2 Percentage of Participants
|
|
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
|
4.3 Percentage of Participants
|
|
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
|
4.3 Percentage of Participants
|
|
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
|
8.7 Percentage of Participants
|
|
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
|
13.0 Percentage of Participants
|
|
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
|
15.2 Percentage of Participants
|
|
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
|
17.4 Percentage of Participants
|
|
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
|
19.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 2 to 16Population: 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.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=44 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
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
|
2.2 Percentage of Participants
|
|
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
|
4.3 Percentage of Participants
|
|
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
|
4.3 Percentage of Participants
|
|
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
|
6.5 Percentage of Participants
|
|
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
|
10.9 Percentage of Participants
|
|
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
|
15.2 Percentage of Participants
|
|
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
|
17.4 Percentage of Participants
|
|
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
|
17.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2,4,6,8,12,16Population: 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.
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.
Outcome measures
| Measure |
Placebo-controlled Phase - Placebo
n=42 Participants
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 Participants
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|---|---|---|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Discomfort/Pain Week 4
|
-6.9 Units on scale
Standard Deviation 30.39
|
-21.6 Units on scale
Standard Deviation 29.21
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Discomfort/Pain Week 6
|
-6.7 Units on scale
Standard Deviation 28.80
|
-22.4 Units on scale
Standard Deviation 33.16
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Discomfort/Pain Week 8
|
-15.5 Units on scale
Standard Deviation 31.14
|
-22.0 Units on scale
Standard Deviation 29.02
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Discomfort/Pain Week 12
|
-14.1 Units on scale
Standard Deviation 32.07
|
-27.6 Units on scale
Standard Deviation 28.14
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Itching Week 2
|
-2.4 Units on scale
Standard Deviation 25.07
|
-25.0 Units on scale
Standard Deviation 24.42
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Itching Week 4
|
-7.9 Units on scale
Standard Deviation 21.39
|
-22.7 Units on scale
Standard Deviation 26.36
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Itching Week 6
|
-9.3 Units on scale
Standard Deviation 29.65
|
-22.4 Units on scale
Standard Deviation 29.37
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Itching Week 8
|
-19.0 Units on scale
Standard Deviation 25.53
|
-24.8 Units on scale
Standard Deviation 29.38
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Itching Week 12
|
-14.9 Units on scale
Standard Deviation 35.82
|
-28.3 Units on scale
Standard Deviation 28.55
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Itching Week 16
|
-10.5 Units on scale
Standard Deviation 30.81
|
-26.8 Units on scale
Standard Deviation 28.65
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Discomfort/Pain Week 2
|
-0.7 Units on scale
Standard Deviation 32.47
|
-20.2 Units on scale
Standard Deviation 26.73
|
|
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Discomfort/Pain Week 16
|
-13.5 Units on scale
Standard Deviation 27.51
|
-25.3 Units on scale
Standard Deviation 29.51
|
Adverse Events
Placebo-controlled Phase - Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo-controlled Phase - Apremilast 30 mg BID
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Active-treatment Phase - Apremilast 30 mg BID
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-controlled Phase - Placebo
n=44 participants at risk
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 participants at risk
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Active-treatment Phase - Apremilast 30 mg BID
n=87 participants at risk
All 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).
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
0.00%
0/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
1.1%
1/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
0.00%
0/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
1.1%
1/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
0.00%
0/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
1.1%
1/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Infections and infestations
Peritonitis
|
0.00%
0/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
0.00%
0/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
1.1%
1/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
Other adverse events
| Measure |
Placebo-controlled Phase - Placebo
n=44 participants at risk
Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Placebo-controlled Phase - Apremilast 30 mg BID
n=46 participants at risk
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
Active-treatment Phase - Apremilast 30 mg BID
n=87 participants at risk
All 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).
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.3%
1/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
15.2%
7/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
6.9%
6/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
6/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
26.1%
12/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
9.2%
8/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Gastrointestinal disorders
Faeces soft
|
4.5%
2/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
10.9%
5/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
3.4%
3/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Gastrointestinal disorders
Nausea
|
4.5%
2/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
13.0%
6/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
3.4%
3/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Infections and infestations
Folliculitis
|
9.1%
4/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
2.2%
1/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
3.4%
3/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
2/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
10.9%
5/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
5.7%
5/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
6.5%
3/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
1.1%
1/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Nervous system disorders
Headache
|
0.00%
0/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
13.0%
6/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
4.6%
4/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.3%
1/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
10.9%
5/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
5.7%
5/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.4%
5/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
6.5%
3/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
3.4%
3/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Musculoskeletal and connective tissue disorders
Pustulotic arthro-osteitis
|
2.3%
1/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
2.2%
1/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
5.7%
5/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
|
Skin and subcutaneous tissue disorders
Palmoplantar pustulosis
|
2.3%
1/44 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
0.00%
0/46 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
9.2%
8/87 • Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER