Trial Outcomes & Findings for Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis (NCT NCT03701763)
NCT ID: NCT03701763
Last Updated: 2024-12-16
Results Overview
The sPGA is the assessment by the Investigator of the overall disease severity of plaque psoriasis at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. The results presented are for the percentage of participants with a sPGA response. An sPGA response was defined as a score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
245 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2024-12-16
Participant Flow
Participants were enrolled into this study at sites in Belgium, Canada, Czech Republic, France, Israel, Italy, Russia, Spain, and the United States.
Screening tests and procedures were performed up to 35 days preceding randomization.
Participant milestones
| Measure |
Placebo
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo/Apremilast
At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast based on baseline weight. Participants 20 to \< 50 kg received apremilast 20 mg BID for 36 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast/Apremilast
At Week 16, participants in the apremilast group during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|---|
|
Placebo-controlled Phase
STARTED
|
82
|
163
|
0
|
0
|
|
Placebo-controlled Phase
Took at Least 1 Dose of Investigational Product (IP)
|
80
|
163
|
0
|
0
|
|
Placebo-controlled Phase
COMPLETED
|
72
|
149
|
0
|
0
|
|
Placebo-controlled Phase
NOT COMPLETED
|
10
|
14
|
0
|
0
|
|
Apremilast Extension Phase
STARTED
|
0
|
0
|
72
|
149
|
|
Apremilast Extension Phase
Received Apremilast 20mg BID in Either Placebo-controlled or Apremilast Extension Phases (Week 0-52)
|
0
|
0
|
36
|
80
|
|
Apremilast Extension Phase
Received Apremilast 30mg BID in Either Placebo-controlled or Apremilast Extension Phases (Week 0-52)
|
0
|
0
|
36
|
83
|
|
Apremilast Extension Phase
Took at Least 1 Dose of IP
|
0
|
0
|
72
|
149
|
|
Apremilast Extension Phase
COMPLETED
|
0
|
0
|
61
|
125
|
|
Apremilast Extension Phase
NOT COMPLETED
|
0
|
0
|
11
|
24
|
|
14-Week Observational Follow-up Phase
STARTED
|
1
|
4
|
14
|
26
|
|
14-Week Observational Follow-up Phase
COMPLETED
|
1
|
3
|
11
|
23
|
|
14-Week Observational Follow-up Phase
NOT COMPLETED
|
0
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
Placebo
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo/Apremilast
At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast based on baseline weight. Participants 20 to \< 50 kg received apremilast 20 mg BID for 36 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast/Apremilast
At Week 16, participants in the apremilast group during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|---|
|
Placebo-controlled Phase
Adverse Event
|
1
|
5
|
0
|
0
|
|
Placebo-controlled Phase
Lack of Efficacy
|
2
|
0
|
0
|
0
|
|
Placebo-controlled Phase
Miscellaneous
|
2
|
0
|
0
|
0
|
|
Placebo-controlled Phase
Withdrawal by Parent/Guardian
|
3
|
5
|
0
|
0
|
|
Placebo-controlled Phase
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Placebo-controlled Phase
Withdrawal by Subject
|
2
|
3
|
0
|
0
|
|
Apremilast Extension Phase
Withdrawal by Subject
|
0
|
0
|
1
|
3
|
|
Apremilast Extension Phase
Lack of Efficacy
|
0
|
0
|
3
|
8
|
|
Apremilast Extension Phase
Adverse Event
|
0
|
0
|
3
|
1
|
|
Apremilast Extension Phase
Miscellaneous
|
0
|
0
|
2
|
1
|
|
Apremilast Extension Phase
Withdrawal by Parent/Guardian
|
0
|
0
|
1
|
8
|
|
Apremilast Extension Phase
Lost to Follow-up
|
0
|
0
|
0
|
2
|
|
Apremilast Extension Phase
Non-compliance with Study Drug
|
0
|
0
|
1
|
1
|
|
14-Week Observational Follow-up Phase
Miscellaneous
|
0
|
0
|
1
|
0
|
|
14-Week Observational Follow-up Phase
Withdrawal by Parent/Guardian
|
0
|
1
|
1
|
0
|
|
14-Week Observational Follow-up Phase
Other
|
0
|
0
|
1
|
0
|
|
14-Week Observational Follow-up Phase
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
14-Week Observational Follow-up Phase
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=82 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants 20 to \< 50 kg received apremilast 20 mg BID for 36 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast
n=163 Participants
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. At Week 16, participants in the apremilast group continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.2 years
STANDARD_DEVIATION 3.25 • n=99 Participants
|
12.3 years
STANDARD_DEVIATION 3.32 • n=107 Participants
|
12.2 years
STANDARD_DEVIATION 3.29 • n=206 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
The sPGA is the assessment by the Investigator of the overall disease severity of plaque psoriasis at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. The results presented are for the percentage of participants with a sPGA response. An sPGA response was defined as a score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=82 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16
|
33.1 percentage of participants
|
11.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
The Psoriasis Area Severity Index (PASI) 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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The results presented are for the percentage of participants with PASI-75. PASI-75 was defined as at least a 75% reduction in PASI score from baseline.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=82 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) From Baseline at Week 16
|
45.4 percentage of participants
|
16.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
The PASI 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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The results presented are for the percentage of participants with PASI-50. PASI-50 was defined as at least a 50% reduction in PASI score from baseline.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=82 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) From Baseline at Week 16
|
70.5 percentage of participants
|
32.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
The PASI 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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Positive percentage change from baseline scores indicate a worsening of disease severity, and negative percentage change from baseline scores indicate an improvement in disease severity.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=82 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Percentage Change From Baseline in Total PASI Score at Week 16
|
-64.52 percentage change
Standard Error 2.543
|
-37.49 percentage change
Standard Error 3.866
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
BSA is a measurement of involved skin of the whole body affected by psoriasis, which ranges from 0% to 100%. Positive percentage change from baseline indicates that a greater BSA was affected by psoriasis. A negative percentage change from baseline indicates that a lesser BSA was affected by psoriasis.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=82 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Percentage Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16
|
-55.44 percentage change in affected BSA
Standard Error 3.428
|
-20.56 percentage change in affected BSA
Standard Error 5.441
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Measured in participants in the intent-to-treat (ITT) population (which included all participants who were randomized), with a baseline CDLQI Score \>/= 2.
The CDLQI is designed to measure the impact of skin disease on children's quality of life. The CDLQI measures how much the participant's psoriasis has affected them over the last week, and includes 10 questions with possible answers ranging from not at all (score of 0) to very much (score of 3). The CDLQI total score ranged from 0 (no effect on the participant's life) to 30 (extremely large effect on the participant's life). The results presented are for the percentage of participants who achieved a total CDLQI score of 0 or 1 at Week 16.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=148 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=76 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16
|
35.4 percentage of participants
|
31.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
The CDLQI is designed to measure the impact of skin disease on children's quality of life. The CDLQI measures how much the participant's psoriasis has affected them over the last week, and includes 10 questions with possible answers ranging from not at all (score of 0) to very much (score of 3). The CDLQI total score ranged from 0 (no effect on the participant's life) to 30 (extremely large effect on the participant's life). A positive change from baseline score indicates that a participant's quality of life has worsened. A negative change from baseline score indicates that a participant's quality of life has improved.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=82 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Change From Baseline in CDLQI Score at Week 16
|
-5.3 scores on a scale
Standard Error 0.44
|
-2.7 scores on a scale
Standard Error 0.56
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received and adverse event data collected by apremilast dose.
An adverse event (AE) was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of the study. A TEAE is any AE that occurred after first dose of the investigational product.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=80 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
n=83 Participants
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase
|
58 Participants
|
33 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-defined in the statistical analysis plan, data are presented per treatment received and adverse event data collected by apremilast dose.
An AE was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of the study. A TEAE is any AE that occurred after first dose of the investigational product.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=119 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=116 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a TEAE During the Apremilast Exposure Period
|
80 Participants
|
88 Participants
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received and adverse event data collected by apremilast dose.
A TESAE is any AE occurring at any dose after first dose that results in death, is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE), requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay), results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions), is a congenital anomaly/birth defect, or constitutes an important medical event.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=80 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
n=83 Participants
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-defined in the statistical analysis plan, data are presented per treatment received and adverse event data collected by apremilast dose.
A TESAE is any AE occurring at any dose after first dose that results in death, is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE), requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay), results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions), is a congenital anomaly/birth defect, or constitutes an important medical event.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=119 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=116 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a TESAE During the Apremilast Exposure Period
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received and adverse event data collected by apremilast dose.
A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=80 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
n=83 Participants
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase
|
36 Participants
|
12 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-defined in the statistical analysis plan, data are presented per treatment received and adverse event data collected by apremilast dose.
A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=119 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=116 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a TRAE During the Apremilast Exposure Period
|
47 Participants
|
45 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 113 daysPopulation: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product), who had diary entries at each specified time point.
Diarrhea was defined as having 3 or more liquid or watery stools in a day. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants With Diarrhea During the Placebo-controlled Phase
Day 1 to 28
|
67 Participants
|
25 Participants
|
—
|
|
Number of Participants With Diarrhea During the Placebo-controlled Phase
Day 29 to 56
|
51 Participants
|
20 Participants
|
—
|
|
Number of Participants With Diarrhea During the Placebo-controlled Phase
Day 57 to 84
|
41 Participants
|
14 Participants
|
—
|
|
Number of Participants With Diarrhea During the Placebo-controlled Phase
Day 85 to 112
|
29 Participants
|
10 Participants
|
—
|
|
Number of Participants With Diarrhea During the Placebo-controlled Phase
Day >/= 113
|
9 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 365 daysPopulation: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product), who had diary entries at each specified time point.
Diarrhea was defined as having 3 or more liquid or watery stools in a day. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=119 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=116 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 1 to 28
|
47 Participants
|
36 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 29 to 56
|
36 Participants
|
30 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 57 to 84
|
32 Participants
|
22 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 85 to 112
|
19 Participants
|
17 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 113 to 140
|
17 Participants
|
21 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 141 to 168
|
21 Participants
|
16 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 169 to 196
|
17 Participants
|
19 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 197 to 224
|
12 Participants
|
19 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 225 to 252
|
12 Participants
|
20 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 253 to 280
|
16 Participants
|
18 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 281 to 308
|
9 Participants
|
13 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 309 to 336
|
5 Participants
|
12 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day 337 to 364
|
5 Participants
|
7 Participants
|
—
|
|
Number of Participants With Diarrhea During the Apremilast Exposure Period
Day >= 365
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 113 daysPopulation: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product), who had diary entries at each specified time point.
Diarrhea symptoms were nausea, vomiting, abdominal cramps, abdominal pain, fever, bloating, and other symptoms. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 1 to 28 · Nausea
|
32 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 1 to 28 · Vomiting
|
13 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 1 to 28 · Abdominal cramps
|
16 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 1 to 28 · Abdominal pain
|
28 Participants
|
9 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 1 to 28 · Fever
|
5 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 1 to 28 · Bloating
|
8 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 1 to 28 · Other symptoms
|
21 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 1 to 28 · No symptoms
|
33 Participants
|
53 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 29 to 56 · Nausea
|
22 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 29 to 56 · Vomiting
|
6 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 29 to 56 · Abdominal cramps
|
7 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 29 to 56 · Abdominal pain
|
17 Participants
|
9 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 29 to 56 · Fever
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 29 to 56 · Bloating
|
12 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 29 to 56 · Other symptoms
|
17 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 29 to 56 · No symptoms
|
81 Participants
|
56 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 57 to 84 · Nausea
|
12 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 57 to 84 · Vomiting
|
7 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 57 to 84 · Abdominal cramps
|
9 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 57 to 84 · Abdominal pain
|
13 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 57 to 84 · Fever
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 57 to 84 · Bloating
|
6 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 57 to 84 · Other symptoms
|
11 Participants
|
6 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 57 to 84 · No symptoms
|
103 Participants
|
65 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 85 to 112 · Nausea
|
8 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 85 to 112 · Vomiting
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 85 to 112 · Abdominal cramps
|
5 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 85 to 112 · Abdominal pain
|
7 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 85 to 112 · Fever
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 85 to 112 · Bloating
|
5 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 85 to 112 · Other symptoms
|
8 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day 85 to 112 · No symptoms
|
125 Participants
|
66 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day >/= 113 · Nausea
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day >/= 113 · Vomiting
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day >/= 113 · Abdominal cramps
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day >/= 113 · Abdominal pain
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day >/= 113 · Fever
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day >/= 113 · Bloating
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day >/= 113 · Other symptoms
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Day >/= 113 · No symptoms
|
154 Participants
|
79 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 365 daysPopulation: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product), who had diary entries at each specified time point.
Diarrhea symptoms were nausea, vomiting, abdominal cramps, abdominal pain, fever, bloating, and other symptoms. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=119 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=116 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 253 to 280 · Other symptoms
|
2 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 253 to 280 · No symptoms
|
58 Participants
|
55 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 281 to 308 · Nausea
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 281 to 308 · Vomiting
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 281 to 308 · Abdominal cramps
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 281 to 308 · Abdominal pain
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 281 to 308 · Fever
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 281 to 308 · Bloating
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 281 to 308 · Other symptoms
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 281 to 308 · No symptoms
|
49 Participants
|
52 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 309 to 336 · Nausea
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 309 to 336 · Vomiting
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 309 to 336 · Abdominal cramps
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 309 to 336 · Abdominal pain
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 309 to 336 · Fever
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 309 to 336 · Bloating
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 309 to 336 · Other symptoms
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 225 to 252 · Nausea
|
3 Participants
|
9 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 225 to 252 · Vomiting
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 113 to 140 · No symptoms
|
95 Participants
|
68 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 253 to 280 · Bloating
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 141 to 168 · Nausea
|
2 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 141 to 168 · Vomiting
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 141 to 168 · Abdominal cramps
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 141 to 168 · Abdominal pain
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 141 to 168 · Fever
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 141 to 168 · Bloating
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 141 to 168 · Other symptoms
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 141 to 168 · No symptoms
|
95 Participants
|
79 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 169 to 196 · Nausea
|
4 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 169 to 196 · Vomiting
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 169 to 196 · Abdominal cramps
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 169 to 196 · Abdominal pain
|
5 Participants
|
7 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 169 to 196 · Fever
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 169 to 196 · Bloating
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 169 to 196 · Other symptoms
|
0 Participants
|
7 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 169 to 196 · No symptoms
|
87 Participants
|
76 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 197 to 224 · Nausea
|
2 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 197 to 224 · Vomiting
|
0 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 197 to 224 · Abdominal cramps
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 225 to 252 · Abdominal cramps
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 225 to 252 · Abdominal pain
|
1 Participants
|
7 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 225 to 252 · Fever
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 225 to 252 · Bloating
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 225 to 252 · Other symptoms
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 225 to 252 · No symptoms
|
92 Participants
|
64 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 253 to 280 · Nausea
|
4 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 253 to 280 · Vomiting
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 253 to 280 · Abdominal cramps
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 253 to 280 · Abdominal pain
|
3 Participants
|
6 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 253 to 280 · Fever
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 197 to 224 · Abdominal pain
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 197 to 224 · Fever
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 197 to 224 · Bloating
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 197 to 224 · Other symptoms
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 197 to 224 · No symptoms
|
97 Participants
|
72 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 1 to 28 · Nausea
|
21 Participants
|
17 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 1 to 28 · Vomiting
|
4 Participants
|
10 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 1 to 28 · Abdominal cramps
|
9 Participants
|
7 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 1 to 28 · Abdominal pain
|
14 Participants
|
21 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 1 to 28 · Fever
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 1 to 28 · Bloating
|
7 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 1 to 28 · Other symptoms
|
13 Participants
|
11 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 1 to 28 · No symptoms
|
43 Participants
|
38 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 29 to 56 · Nausea
|
10 Participants
|
14 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 29 to 56 · Vomiting
|
3 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 29 to 56 · Abdominal cramps
|
4 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 29 to 56 · Abdominal pain
|
8 Participants
|
13 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 29 to 56 · Fever
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 29 to 56 · Bloating
|
9 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 29 to 56 · Other symptoms
|
9 Participants
|
9 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 29 to 56 · No symptoms
|
70 Participants
|
59 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 57 to 84 · Nausea
|
8 Participants
|
6 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 57 to 84 · Vomiting
|
4 Participants
|
6 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 57 to 84 · Abdominal cramps
|
3 Participants
|
8 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 57 to 84 · Abdominal pain
|
6 Participants
|
10 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 57 to 84 · Fever
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 57 to 84 · Bloating
|
6 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 57 to 84 · Other symptoms
|
6 Participants
|
10 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 57 to 84 · No symptoms
|
76 Participants
|
59 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 85 to 112 · Nausea
|
5 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 85 to 112 · Vomiting
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 85 to 112 · Abdominal cramps
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 85 to 112 · Abdominal pain
|
3 Participants
|
6 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 85 to 112 · Fever
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 85 to 112 · Bloating
|
4 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 85 to 112 · Other symptoms
|
4 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 85 to 112 · No symptoms
|
86 Participants
|
76 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 113 to 140 · Nausea
|
2 Participants
|
6 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 113 to 140 · Vomiting
|
1 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 113 to 140 · Abdominal cramps
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 113 to 140 · Abdominal pain
|
3 Participants
|
7 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 113 to 140 · Fever
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 113 to 140 · Bloating
|
2 Participants
|
3 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 113 to 140 · Other symptoms
|
3 Participants
|
5 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 309 to 336 · No symptoms
|
57 Participants
|
47 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 337 to 364 · Nausea
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 337 to 364 · Vomiting
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 337 to 364 · Abdominal cramps
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 337 to 364 · Abdominal pain
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 337 to 364 · Fever
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 337 to 364 · Bloating
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 337 to 364 · Other symptoms
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day 337 to 364 · No symptoms
|
54 Participants
|
52 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day >= 365 · Nausea
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day >= 365 · Vomiting
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day >= 365 · Abdominal cramps
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day >= 365 · Abdominal pain
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day >= 365 · Fever
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day >= 365 · Bloating
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day >= 365 · Other symptoms
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Day >= 365 · No symptoms
|
21 Participants
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
The C-SSRS is a questionnaire that is used to assess suicidal ideation and behavior. The C-SSRS questionnaire measures suicidal ideation, intensity of ideation, and suicidal behaviors. Results presented are for the number of participants who recorded suicidal ideation or behavior on the C-SSRS.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants With Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 16 to Week 52Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product who had available C-SSRS data.
The C-SSRS is a questionnaire that is used to assess suicidal ideation and behavior. The C-SSRS questionnaire measures suicidal ideation, intensity of ideation, and suicidal behaviors. Results presented are for the number of participants who recorded suicidal ideation or behavior on the C-SSRS.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=111 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=110 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants With Suicidal Ideation or Behavior Per the C-SSRS During the Apremilast-extension Phase
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product and had available data for the endpoint. As pre-specified, results are presented based on initial treatment received.
The Tanner Staging of sexual development is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on characteristics, such as the size of the breasts, genitals, testicular volume, and growth of pubic hair. The scale ranges from stage I (pre-adolescent) to stage V (adult development). The results presented are for the number of participants at stage I-V of development.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=89 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=37 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Breast Growth · Stage 1
|
17 Participants
|
8 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Breast Growth · Stage 2
|
9 Participants
|
3 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Breast Growth · Stage 3
|
9 Participants
|
3 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Breast Growth · Stage 4
|
20 Participants
|
6 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Breast Growth · Stage 5
|
27 Participants
|
12 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Breast Growth · Missing
|
7 Participants
|
5 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 1
|
18 Participants
|
8 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 2
|
9 Participants
|
3 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 3
|
9 Participants
|
3 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 4
|
18 Participants
|
6 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 5
|
28 Participants
|
12 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Missing
|
7 Participants
|
5 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 1
|
18 Participants
|
8 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 2
|
9 Participants
|
3 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 3
|
12 Participants
|
3 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 4
|
16 Participants
|
4 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 5
|
26 Participants
|
12 Participants
|
—
|
|
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Missing
|
8 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product and had available data for the endpoint. As pre-specified, results are presented based on initial treatment received.
The Tanner Staging of sexual development is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on characteristics, such as the size of the breasts, genitals, testicular volume, and growth of pubic hair. The scale ranges from stage I (pre-adolescent) to stage V (adult development). The results presented are for the number of participants at stage I-V of development.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=74 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=43 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Testes Growth · Stage 1
|
15 Participants
|
11 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Testes Growth · Stage 2
|
5 Participants
|
5 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Testes Growth · Stage 3
|
10 Participants
|
4 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Testes Growth · Stage 4
|
12 Participants
|
5 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Testes Growth · Stage 5
|
27 Participants
|
14 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Testes Growth · Missing
|
5 Participants
|
4 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Penis Growth · Stage 1
|
15 Participants
|
11 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Penis Growth · Stage 2
|
5 Participants
|
5 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Penis Growth · Stage 3
|
11 Participants
|
4 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Penis Growth · Stage 4
|
10 Participants
|
5 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Penis Growth · Stage 5
|
28 Participants
|
14 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Penis Growth · Missing
|
5 Participants
|
4 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 1
|
15 Participants
|
10 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 2
|
6 Participants
|
5 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 3
|
8 Participants
|
5 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 4
|
14 Participants
|
6 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Stage 5
|
26 Participants
|
13 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Pubic Hair Growth · Missing
|
5 Participants
|
4 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 1
|
15 Participants
|
9 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 2
|
5 Participants
|
5 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 3
|
8 Participants
|
4 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 4
|
11 Participants
|
4 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Stage 5
|
26 Participants
|
14 Participants
|
—
|
|
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Other Changes · Missing
|
9 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
The participants' body weight in kilograms (kg) was recorded.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Mean Body Weight of Participants During the Placebo-controlled Phase
Baseline
|
52.04 kg
Standard Deviation 21.123
|
52.36 kg
Standard Deviation 22.177
|
—
|
|
Mean Body Weight of Participants During the Placebo-controlled Phase
Week 16
|
51.95 kg
Standard Deviation 20.945
|
54.18 kg
Standard Deviation 22.581
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
The participants' body weight in kilograms (kg) was recorded.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=119 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=116 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Mean Body Weight of Participants During the Apremilast Exposure Period
Baseline
|
67.94 kg
Standard Deviation 19.053
|
36.81 kg
Standard Deviation 8.954
|
—
|
|
Mean Body Weight of Participants During the Apremilast Exposure Period
Week 52
|
67.79 kg
Standard Deviation 18.889
|
39.04 kg
Standard Deviation 9.823
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
The participants' height in centimeters (cm) was recorded.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Mean Height of Participants During the Placebo-controlled Phase
Baseline
|
153.33 cm
Standard Deviation 18.069
|
153.29 cm
Standard Deviation 18.435
|
—
|
|
Mean Height of Participants During the Placebo-controlled Phase
Week 16
|
154.40 cm
Standard Deviation 17.683
|
154.54 cm
Standard Deviation 17.839
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
The participants' height in centimeters (cm) was recorded.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=119 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=116 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Mean Height of Participants During the Apremilast Exposure Period
Baseline
|
166.13 cm
Standard Deviation 11.416
|
140.86 cm
Standard Deviation 14.159
|
—
|
|
Mean Height of Participants During the Apremilast Exposure Period
Week 52
|
167.84 cm
Standard Deviation 10.814
|
144.90 cm
Standard Deviation 13.944
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
The participants' BMI was calculated as body weight (kg)/height (m\^2).
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase
Baseline
|
21.33 kg/m^2
Standard Deviation 5.197
|
21.41 kg/m^2
Standard Deviation 5.652
|
—
|
|
Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase
Week 16
|
20.98 kg/m^2
Standard Deviation 5.067
|
21.87 kg/m^2
Standard Deviation 5.883
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
The participants' BMI was calculated as body weight (kg)/height (m\^2).
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=119 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=116 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Mean BMI of Participants During the Apremilast Exposure Period
Week 52
|
23.95 kg/m^2
Standard Deviation 5.539
|
18.30 kg/m^2
Standard Deviation 2.480
|
—
|
|
Mean BMI of Participants During the Apremilast Exposure Period
Baseline
|
24.52 kg/m^2
Standard Deviation 5.655
|
18.32 kg/m^2
Standard Deviation 2.641
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.
A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=163 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=80 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Psoriasis Flare During the Placebo-controlled Phase
|
2 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-defined in the statistical analysis plan, data are presented per treatment received.
A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=119 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=116 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Psoriasis Flare During the Apremilast Exposure Period
|
11 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: 14 weeks post last dose (max mean treatment duration in placebo-controlled phase was 15.3 weeks, and 41.9 weeks in the apremilast-exposure period)Population: Measured in participants in the Safety Population (which included all randomized participants who received at least 1 dose of investigational product) who entered the 14-week observational follow up.
A psoriasis rebound was defined as an adverse event of psoriasis that started after the last dose date for participants who received treatment in the study.
Outcome measures
| Measure |
Apremilast Exposure Period: Apremilast 30 mg BID
n=14 Participants
Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo
n=1 Participants
In the placebo-controlled phase, participants who were randomized to placebo received placebo twice daily (BID) for 16 weeks. At Week 16, participants in the placebo group were switched to apremilast based on baseline weight. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast 30 mg
n=30 Participants
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Psoriasis Rebound
|
0 Participants
|
0 Participants
|
4 Participants
|
Adverse Events
Placebo-Controlled Phase: Placebo BID
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo-Controlled Phase: Apremilast 20 mg BID
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo-Controlled Phase: Apremilast 30 mg BID
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo-Controlled Phase: Apremilast BID
Serious events: 2 serious events
Other events: 91 other events
Deaths: 0 deaths
Apremilast Extension Phase: Apremilast 20 mg BID
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Apremilast Extension Phase: Apremilast 30 mg BID
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Apremilast Extension Phase: Apremilast BID
Serious events: 2 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Controlled Phase: Placebo BID
n=80 participants at risk
In the placebo-controlled phase, participants who were randomized to placebo received placebo BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo-Controlled Phase: Apremilast 20 mg BID
n=80 participants at risk
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo-Controlled Phase: Apremilast 30 mg BID
n=83 participants at risk
In the placebo-controlled phase, participants who were randomized to apremilast who were \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo-Controlled Phase: Apremilast BID
n=163 participants at risk
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast Extension Phase: Apremilast 20 mg BID
n=110 participants at risk
At Week 16, participants 20 to \< 50 kg received apremilast 20 mg BID for 36 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast Extension Phase: Apremilast 30 mg BID
n=111 participants at risk
At Week 16, participants \>/= 50 kg received apremilast 30 mg BID for 36 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast Extension Phase: Apremilast BID
n=221 participants at risk
At Week 16, participants 20 to \< 50 kg received apremilast 20 mg BID for 36 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 36 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.2%
1/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.61%
1/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.2%
1/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.61%
1/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Cardiac disorders
Wandering pacemaker
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.2%
1/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.61%
1/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.90%
1/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.45%
1/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.2%
1/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.61%
1/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Nervous system disorders
Status migrainosus
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.90%
1/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.45%
1/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Reproductive system and breast disorders
Testicular appendage torsion
|
1.2%
1/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.2%
1/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.61%
1/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
Other adverse events
| Measure |
Placebo-Controlled Phase: Placebo BID
n=80 participants at risk
In the placebo-controlled phase, participants who were randomized to placebo received placebo BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo-Controlled Phase: Apremilast 20 mg BID
n=80 participants at risk
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo-Controlled Phase: Apremilast 30 mg BID
n=83 participants at risk
In the placebo-controlled phase, participants who were randomized to apremilast who were \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Placebo-Controlled Phase: Apremilast BID
n=163 participants at risk
In the placebo-controlled phase, participants who were randomized to apremilast who were 20 to \< 50 kg received apremilast 20 mg twice daily (BID) for 16 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 16 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast Extension Phase: Apremilast 20 mg BID
n=110 participants at risk
At Week 16, participants 20 to \< 50 kg received apremilast 20 mg BID for 36 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast Extension Phase: Apremilast 30 mg BID
n=111 participants at risk
At Week 16, participants \>/= 50 kg received apremilast 30 mg BID for 36 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
Apremilast Extension Phase: Apremilast BID
n=221 participants at risk
At Week 16, participants 20 to \< 50 kg received apremilast 20 mg BID for 36 weeks, and participants \>/= 50 kg received apremilast 30 mg BID for 36 weeks. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
8/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
28.7%
23/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
10.8%
9/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
19.6%
32/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
12.7%
14/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
4.5%
5/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
8.6%
19/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
4/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.2%
5/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
4.8%
4/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
5.5%
9/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
4.5%
5/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
2.3%
5/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
8/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
18.8%
15/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
20.5%
17/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
19.6%
32/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
18.2%
20/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
11.7%
13/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
14.9%
33/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
3.8%
3/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
8.4%
7/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.1%
10/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.8%
2/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.8%
2/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.8%
4/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
18.8%
15/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
20.5%
17/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
19.6%
32/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
16.4%
18/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
9.0%
10/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
12.7%
28/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
20.0%
16/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
15.7%
13/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
17.8%
29/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
13.6%
15/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.3%
7/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
10.0%
22/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
General disorders
Pyrexia
|
1.2%
1/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
8.8%
7/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
3.6%
3/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.1%
10/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
3.6%
4/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.90%
1/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
2.3%
5/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Infections and infestations
COVID-19
|
6.2%
5/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
2.5%
2/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
3.6%
3/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
3.1%
5/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
3.6%
4/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
2.7%
3/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
3.2%
7/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Infections and infestations
Influenza
|
1.2%
1/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.2%
5/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
2.4%
2/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
4.3%
7/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
3.6%
4/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.8%
2/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
2.7%
6/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
3/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.2%
5/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.0%
5/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.1%
10/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
7.3%
8/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
2.7%
3/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
5.0%
11/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Nervous system disorders
Headache
|
5.0%
4/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
15.0%
12/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.0%
5/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
10.4%
17/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
6.4%
7/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
4.5%
5/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
5.4%
12/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.8%
3/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
0.00%
0/80 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
2.4%
2/83 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
1.2%
2/163 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
4.5%
5/110 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
9.9%
11/111 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
7.2%
16/221 • Up to a maximum of 52 weeks
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.
|
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