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)

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

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

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

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=5 Participants	12.3 years STANDARD_DEVIATION 3.32 • n=7 Participants	12.2 years STANDARD_DEVIATION 3.29 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	89 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	74 Participants n=7 Participants	117 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	24 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=5 Participants	129 Participants n=7 Participants	200 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants	140 Participants n=7 Participants	213 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.

Outcome measures

Outcome measures
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 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. 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	11.5 percentage of participants	33.1 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: 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

Outcome measures
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 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. 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	16.1 percentage of participants	45.4 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: 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

Outcome measures
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 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. 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	32.1 percentage of participants	70.5 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: 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

Outcome measures
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 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. 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	-37.49 percentage change Standard Error 3.866	-64.52 percentage change Standard Error 2.543	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: 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

Outcome measures
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 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. 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	-20.56 percentage change in affected BSA Standard Error 5.441	-55.44 percentage change in affected BSA Standard Error 3.428	—

SECONDARY outcome

Timeframe: Week 16

Population: 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

Outcome measures
Measure	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 n=148 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.	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	31.3 percentage of participants	35.4 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: 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

Outcome measures
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 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. 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	-2.7 scores on a scale Standard Error 0.56	-5.3 scores on a scale Standard Error 0.44	—

SECONDARY outcome

Timeframe: 16 weeks

Population: 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

Outcome measures
Measure	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 n=80 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.	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	33 Participants	58 Participants	48 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: 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

Outcome measures
Measure	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 n=119 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.	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	88 Participants	80 Participants	—

SECONDARY outcome

Timeframe: 16 weeks

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

Outcome measures
Measure	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 n=80 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.	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	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 52 weeks

Outcome measures

Outcome measures
Measure	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 n=119 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.	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	2 Participants	1 Participants	—

SECONDARY outcome

Timeframe: 16 weeks

A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.

Outcome measures

Outcome measures
Measure	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 n=80 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.	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	12 Participants	36 Participants	32 Participants

SECONDARY outcome

Timeframe: 52 weeks

A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.

Outcome measures

Outcome measures
Measure	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 n=119 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.	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	45 Participants	47 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 113 days

Population: 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

Outcome measures
Measure	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 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. 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	25 Participants	67 Participants	—
Number of Participants With Diarrhea During the Placebo-controlled Phase Day 29 to 56	20 Participants	51 Participants	—
Number of Participants With Diarrhea During the Placebo-controlled Phase Day 57 to 84	14 Participants	41 Participants	—
Number of Participants With Diarrhea During the Placebo-controlled Phase Day 85 to 112	10 Participants	29 Participants	—
Number of Participants With Diarrhea During the Placebo-controlled Phase Day >/= 113	2 Participants	9 Participants	—

SECONDARY outcome

Timeframe: Day 1 up to approximately 365 days

Outcome measures

Outcome measures
Measure	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 n=119 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.	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	36 Participants	47 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 29 to 56	30 Participants	36 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 57 to 84	22 Participants	32 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 85 to 112	17 Participants	19 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 113 to 140	21 Participants	17 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 141 to 168	16 Participants	21 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 169 to 196	19 Participants	17 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 197 to 224	19 Participants	12 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 225 to 252	20 Participants	12 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 253 to 280	18 Participants	16 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 281 to 308	13 Participants	9 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 309 to 336	12 Participants	5 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day 337 to 364	7 Participants	5 Participants	—
Number of Participants With Diarrhea During the Apremilast Exposure Period Day >= 365	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 113 days

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

Outcome measures
Measure	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 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. 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	3 Participants	32 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 1 to 28 · Vomiting	2 Participants	13 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 1 to 28 · Abdominal cramps	3 Participants	16 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 1 to 28 · Abdominal pain	9 Participants	28 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 1 to 28 · Fever	1 Participants	5 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 1 to 28 · Bloating	1 Participants	8 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 1 to 28 · Other symptoms	5 Participants	21 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 1 to 28 · No symptoms	53 Participants	33 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 29 to 56 · Nausea	2 Participants	22 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 29 to 56 · Vomiting	2 Participants	6 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 29 to 56 · Abdominal cramps	3 Participants	7 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 29 to 56 · Abdominal pain	9 Participants	17 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 29 to 56 · Fever	0 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 29 to 56 · Bloating	4 Participants	12 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 29 to 56 · Other symptoms	4 Participants	17 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 29 to 56 · No symptoms	56 Participants	81 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 57 to 84 · Nausea	1 Participants	12 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 57 to 84 · Vomiting	0 Participants	7 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 57 to 84 · Abdominal cramps	1 Participants	9 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 57 to 84 · Abdominal pain	5 Participants	13 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 57 to 84 · Fever	0 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 57 to 84 · Bloating	2 Participants	6 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 57 to 84 · Other symptoms	6 Participants	11 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 57 to 84 · No symptoms	65 Participants	103 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 85 to 112 · Nausea	2 Participants	8 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 85 to 112 · Vomiting	1 Participants	3 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 85 to 112 · Abdominal cramps	1 Participants	5 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 85 to 112 · Abdominal pain	2 Participants	7 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 85 to 112 · Fever	0 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 85 to 112 · Bloating	3 Participants	5 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 85 to 112 · Other symptoms	5 Participants	8 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day 85 to 112 · No symptoms	66 Participants	125 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day >/= 113 · Nausea	0 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day >/= 113 · Vomiting	0 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day >/= 113 · Abdominal cramps	0 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day >/= 113 · Abdominal pain	0 Participants	2 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	0 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase Day >/= 113 · No symptoms	79 Participants	154 Participants	—

SECONDARY outcome

Timeframe: Day 1 up to approximately 365 days

Outcome measures

Outcome measures
Measure	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 n=119 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.	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 141 to 168 · Vomiting	3 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 141 to 168 · Abdominal cramps	2 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 1 to 28 · Nausea	17 Participants	21 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 1 to 28 · Vomiting	10 Participants	4 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 1 to 28 · Abdominal cramps	7 Participants	9 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 1 to 28 · Abdominal pain	21 Participants	14 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 1 to 28 · Fever	2 Participants	3 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 1 to 28 · Bloating	3 Participants	7 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 1 to 28 · Other symptoms	11 Participants	13 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 1 to 28 · No symptoms	38 Participants	43 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 29 to 56 · Nausea	14 Participants	10 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 29 to 56 · Vomiting	4 Participants	3 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 85 to 112 · Other symptoms	5 Participants	4 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 85 to 112 · No symptoms	76 Participants	86 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 113 to 140 · Nausea	6 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 113 to 140 · Vomiting	5 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 113 to 140 · Abdominal cramps	4 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 113 to 140 · Abdominal pain	7 Participants	3 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 113 to 140 · Fever	1 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 113 to 140 · Bloating	3 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 113 to 140 · Other symptoms	5 Participants	3 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 113 to 140 · No symptoms	68 Participants	95 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 141 to 168 · Nausea	5 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 141 to 168 · Abdominal pain	4 Participants	2 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	3 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 141 to 168 · No symptoms	79 Participants	95 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 169 to 196 · Nausea	3 Participants	4 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 169 to 196 · Vomiting	2 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 169 to 196 · Abdominal cramps	1 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 169 to 196 · Abdominal pain	7 Participants	5 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 169 to 196 · Fever	0 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 169 to 196 · Bloating	0 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 169 to 196 · Other symptoms	7 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 169 to 196 · No symptoms	76 Participants	87 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 197 to 224 · Nausea	5 Participants	2 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	13 Participants	8 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 29 to 56 · Fever	1 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 29 to 56 · Bloating	4 Participants	9 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 197 to 224 · Vomiting	5 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 197 to 224 · Abdominal cramps	1 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 197 to 224 · Abdominal pain	3 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 197 to 224 · Fever	2 Participants	0 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	4 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 197 to 224 · No symptoms	72 Participants	97 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 225 to 252 · Nausea	9 Participants	3 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 225 to 252 · Vomiting	3 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 225 to 252 · Abdominal cramps	2 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 225 to 252 · Abdominal pain	7 Participants	1 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	3 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 225 to 252 · Other symptoms	4 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 225 to 252 · No symptoms	64 Participants	92 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 253 to 280 · Nausea	5 Participants	4 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 253 to 280 · Vomiting	1 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 253 to 280 · Abdominal cramps	3 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 253 to 280 · Abdominal pain	6 Participants	3 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 253 to 280 · Fever	1 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 253 to 280 · Bloating	2 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 253 to 280 · Other symptoms	3 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 253 to 280 · No symptoms	55 Participants	58 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	59 Participants	70 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 57 to 84 · Nausea	6 Participants	8 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 281 to 308 · Nausea	2 Participants	3 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 281 to 308 · Vomiting	1 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 281 to 308 · Abdominal cramps	1 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 57 to 84 · Vomiting	6 Participants	4 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 57 to 84 · Abdominal pain	10 Participants	6 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 281 to 308 · Abdominal pain	4 Participants	2 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 57 to 84 · Fever	1 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 281 to 308 · Bloating	0 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 57 to 84 · Abdominal cramps	8 Participants	3 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	52 Participants	49 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 309 to 336 · Nausea	2 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 309 to 336 · Vomiting	2 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 309 to 336 · Abdominal cramps	1 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 309 to 336 · Abdominal pain	4 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 309 to 336 · Fever	1 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 309 to 336 · Bloating	1 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 309 to 336 · Other symptoms	4 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 309 to 336 · No symptoms	47 Participants	57 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 337 to 364 · Nausea	2 Participants	1 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 337 to 364 · Vomiting	1 Participants	0 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	1 Participants	0 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	52 Participants	54 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 57 to 84 · Bloating	1 Participants	6 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 57 to 84 · Other symptoms	10 Participants	6 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 57 to 84 · No symptoms	59 Participants	76 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 85 to 112 · Nausea	3 Participants	5 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 85 to 112 · Vomiting	3 Participants	0 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 85 to 112 · Abdominal cramps	4 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 85 to 112 · Abdominal pain	6 Participants	3 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 85 to 112 · Fever	1 Participants	2 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day 85 to 112 · Bloating	2 Participants	4 Participants	—
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period Day >= 365 · Abdominal cramps	0 Participants	1 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	24 Participants	21 Participants	—

SECONDARY outcome

Timeframe: 16 weeks

Population: 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

Outcome measures
Measure	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 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. 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 52

Population: 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.

Outcome measures

Outcome measures
Measure	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 n=111 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.	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 52

Population: 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

Outcome measures
Measure	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 n=89 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.	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 · Missing	5 Participants	7 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 1	8 Participants	18 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 2	3 Participants	9 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 3	3 Participants	9 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 4	6 Participants	18 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 5	12 Participants	28 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Missing	5 Participants	7 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Stage 1	8 Participants	18 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Stage 2	3 Participants	9 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Stage 3	3 Participants	12 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Stage 4	4 Participants	16 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Stage 5	12 Participants	26 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Missing	7 Participants	8 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Breast Growth · Stage 2	3 Participants	9 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Breast Growth · Stage 3	3 Participants	9 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Breast Growth · Stage 4	6 Participants	20 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Breast Growth · Stage 5	12 Participants	27 Participants	—
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Breast Growth · Stage 1	8 Participants	17 Participants	—

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Outcome measures
Measure	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 n=74 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.	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 4	5 Participants	12 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Missing	4 Participants	5 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Testes Growth · Stage 1	11 Participants	15 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	4 Participants	10 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Testes Growth · Stage 5	14 Participants	27 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Testes Growth · Missing	4 Participants	5 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Penis Growth · Stage 1	11 Participants	15 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	4 Participants	11 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Penis Growth · Stage 4	5 Participants	10 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Penis Growth · Stage 5	14 Participants	28 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Penis Growth · Missing	4 Participants	5 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 1	10 Participants	15 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 2	5 Participants	6 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 3	5 Participants	8 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 4	6 Participants	14 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Pubic Hair Growth · Stage 5	13 Participants	26 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Stage 1	9 Participants	15 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	4 Participants	8 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Stage 4	4 Participants	11 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Stage 5	14 Participants	26 Participants	—
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development Other Changes · Missing	7 Participants	9 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: 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

Outcome measures
Measure	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 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. 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	52.36 kg Standard Deviation 22.177	52.04 kg Standard Deviation 21.123	—
Mean Body Weight of Participants During the Placebo-controlled Phase Week 16	54.18 kg Standard Deviation 22.581	51.95 kg Standard Deviation 20.945	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: 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

Outcome measures
Measure	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 n=119 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.	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	36.81 kg Standard Deviation 8.954	67.94 kg Standard Deviation 19.053	—
Mean Body Weight of Participants During the Apremilast Exposure Period Week 52	39.04 kg Standard Deviation 9.823	67.79 kg Standard Deviation 18.889	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: 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

Outcome measures
Measure	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 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. 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	153.29 cm Standard Deviation 18.435	153.33 cm Standard Deviation 18.069	—
Mean Height of Participants During the Placebo-controlled Phase Week 16	154.54 cm Standard Deviation 17.839	154.40 cm Standard Deviation 17.683	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: 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

Outcome measures
Measure	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 n=119 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.	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	140.86 cm Standard Deviation 14.159	166.13 cm Standard Deviation 11.416	—
Mean Height of Participants During the Apremilast Exposure Period Week 52	144.90 cm Standard Deviation 13.944	167.84 cm Standard Deviation 10.814	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: 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

Outcome measures
Measure	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 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. 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	21.41 kg/m^2 Standard Deviation 5.652	21.33 kg/m^2 Standard Deviation 5.197	—
Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase Week 16	21.87 kg/m^2 Standard Deviation 5.883	20.98 kg/m^2 Standard Deviation 5.067	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: 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

Outcome measures
Measure	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 n=119 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.	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 Baseline	18.32 kg/m^2 Standard Deviation 2.641	24.52 kg/m^2 Standard Deviation 5.655	—
Mean BMI of Participants During the Apremilast Exposure Period Week 52	18.30 kg/m^2 Standard Deviation 2.480	23.95 kg/m^2 Standard Deviation 5.539	—

SECONDARY outcome

Timeframe: 16 weeks

Population: 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

Outcome measures
Measure	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 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. 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	3 Participants	2 Participants	—

SECONDARY outcome

Timeframe: 52 weeks

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

Outcome measures
Measure	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 n=119 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.	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	7 Participants	11 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

Outcome measures
Measure	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 n=14 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.	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

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

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

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

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