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Clinical Trial Results:
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Summary
EudraCT number	2018-002918-12
Trial protocol	FR NL CZ HU BE IT
Global end of trial date	27 Mar 2023

Results information
Results version number	v1(current)
This version publication date	07 Oct 2023
First version publication date	07 Oct 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CC-10004-PPSO-003

ISRCTN number

US NCT number

NCT03701763

WHO universal trial number (UTN)

Sponsor organisation name

Amgen Inc.

Sponsor organisation address

One Amgen Center Drive, Thousand Oaks, CA, United States,

Public contact

IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com

Scientific contact

Study Director, Amgen Inc., medinfo@amgen.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

27 Mar 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

27 Mar 2023

Was the trial ended prematurely?

Main objective of the trial

The primary objective of the study was to evaluate the clinical efficacy of apremilast compared with placebo in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.

Protection of trial subjects

This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines and in accordance with the general ethical principles outlined in the Declaration of Helsinki.

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Dec 2018

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy, Safety

Long term follow-up duration

4 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 16

Country: Number of subjects enrolled

Belgium: 7

Country: Number of subjects enrolled

Czechia: 5

Country: Number of subjects enrolled

France: 7

Country: Number of subjects enrolled

Italy: 11

Country: Number of subjects enrolled

Russian Federation: 103

Country: Number of subjects enrolled

Spain: 31

Country: Number of subjects enrolled

Israel: 7

Country: Number of subjects enrolled

United States: 58

Worldwide total number of subjects

245

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

101

Adolescents (12-17 years)

144

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants were enrolled into this study at sites in Belgium, Canada, Czech Republic, France, Israel, Italy, Russia, Spain, and the United States.

Screening details

Screening tests and procedures were performed up to 35 days preceding randomization.

Period 1 title

Placebo-controlled Phase

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo

Arm description

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.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Apremilast

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Apremilast

Investigational medicinal product code

Other name

Otezla®

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Number of subjects in period 1	Placebo	Apremilast
Started	82	163
Took Investigational Product (IP)	80	163
Completed	72	149
Not completed	10	14
Consent withdrawn by subject	2	3
Adverse event, non-fatal	1	5
Miscellaneous	2	-
Withdrawal by Parent/Guardian	3	5
Lost to follow-up	-	1
Lack of efficacy	2	-

Period 2 title

Apremilast Extension Phase

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Placebo/Apremilast

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Apremilast

Investigational medicinal product code

Other name

Otezla®

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Apremilast/Apremilast

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Apremilast

Investigational medicinal product code

Other name

Otezla®

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Number of subjects in period 2	Placebo/Apremilast	Apremilast/Apremilast
Started	72	149
Apremilast 20mg Apremilast Exposure Prd	36 ^[1]	80 ^[2]
Apremilast 30mg Apremilast Exposure Prd	36 ^[3]	83 ^[4]
Took at Least 1 Dose of IP	72	149
Completed	61	125
Not completed	11	24
Non-compliance with Study Drug	1	1
Consent withdrawn by subject	1	3
Adverse event, non-fatal	3	1
Miscellaneous	2	1
Withdrawal by Parent/Guardian	1	8
Lost to follow-up	-	2
Lack of efficacy	3	8

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Includes participants who received apremilast 20mg during the apremilast exposure period.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Includes participants who received apremilast 20mg during the apremilast exposure period.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Includes participants who received apremilast 30mg during the apremilast exposure period.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Includes participants who received apremilast 30mg during the apremilast exposure period.

Period 3 title

14-Week Observational Follow-up Phase

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Placebo

Arm description

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.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Apremilast

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Apremilast

Investigational medicinal product code

Other name

Otezla®

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Placebo/Apremilast

Arm description

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Investigational medicinal product name

Apremilast

Investigational medicinal product code

Other name

Otezla®

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Apremilast/Apremilast

Arm description

Arm type

Experimental

Investigational medicinal product name

Apremilast

Investigational medicinal product code

Other name

Otezla®

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets

Number of subjects in period 3 ^[5]	Placebo	Apremilast	Placebo/Apremilast	Apremilast/Apremilast
Started	1	4	14	26
Completed	1	3	11	23
Not completed	0	1	3	3
Consent withdrawn by subject	-	-	-	2
Miscellaneous	-	-	1	-
Withdrawal by Parent/Guardian	-	1	1	-
Study Terminated by Sponsor	-	-	1	-
Lost to follow-up	-	-	-	1

Notes
[5] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Includes participants who completed the study or discontinued the study early who opted to enter the 14-week observational follow up.

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

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.

Reporting group title

Apremilast

Reporting group description

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.

Reporting group values	Placebo	Apremilast	Total
Number of subjects	82	163	245
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	34	67	101
Adolescents (12-17 years)	48	96	144
Adults (18-64 years)	0	0	0
From 65-84 years	0	0	0
85 years and over	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	12.2 ( 3.25 )	12.3 ( 3.32 )	-
Sex: Female, Male
Units: participants
Female	39	89	128
Male	43	74	117
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	2	2
Asian	3	6	9
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	3	5	8
White	73	140	213
More than one race	0	0	0
Unknown or Not Reported	3	10	13
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	8	24	32
Not Hispanic or Latino	71	129	200
Unknown or Not Reported	3	10	13

End points

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Reporting group title

Placebo

Reporting group description

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.

Reporting group title

Apremilast

Reporting group description

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.

Reporting group title

Placebo/Apremilast

Reporting group description

Reporting group title

Apremilast/Apremilast

Reporting group description

Reporting group title

Placebo

Reporting group description

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.

Reporting group title

Apremilast

Reporting group description

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.

Reporting group title

Placebo/Apremilast

Reporting group description

Reporting group title

Apremilast/Apremilast

Reporting group description

Subject analysis set title

Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

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. The arms for this endpoint are different to those in the overall study reporting group. Due to constraints of the EudraCT system, these arms have had to be added as subject analysis sets.

Subject analysis set title

Apremilast 20 mg

Subject analysis set type

Safety analysis

Subject analysis set description

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. The arms for this endpoint are different to those in the overall study reporting group. Due to constraints of the EudraCT system, these arms have had to be added as subject analysis sets

Subject analysis set title

Apremilast 30 mg

Subject analysis set type

Safety analysis

Subject analysis set description

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. The arms for this endpoint are different to those in the overall study reporting group. Due to constraints of the EudraCT system, these arms have had to be added as subject analysis sets.

Subject analysis set title

Apremilast-extension Phase: Apremilast 20 mg BID

Subject analysis set type

Safety analysis

Subject analysis set description

At Week 16, participants 20 to < 50 kg received apremilast 20 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. The arms for this endpoint are different to those in the overall study reporting group. Due to constraints of the EudraCT system, these arms have had to be added as subject analysis sets.

Subject analysis set title

Apremilast-extension Phase: Apremilast 30 mg BID

Subject analysis set type

Safety analysis

Subject analysis set description

At Week 16, 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. The arms for this endpoint are different to those in the overall study reporting group. Due to constraints of the EudraCT system, these arms have had to be added as subject analysis sets.

Subject analysis set title

Apremilast Exposure Period: Apremilast 20 mg BID

Subject analysis set type

Safety analysis

Subject analysis set description

Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 20 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 20mg BID for 36 weeks based on baseline weight. Participants who received apremilast 20 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.

Subject analysis set title

Apremilast Exposure Period: Apremilast 30 mg BID

Subject analysis set type

Safety analysis

Subject analysis set description

Participants who were randomized to apremilast during the placebo-controlled phase and received apremilast 30 mg BID for 16 weeks during the placebo-controlled phase. At Week 16, participants in the placebo group during the placebo-controlled phase were switched to apremilast 30mg BID for 36 weeks based on baseline weight. Participants who received apremilast 30 mg BID during the placebo-controlled phase continued to receive their original dosing assignment for an additional 36 weeks during the apremilast-extension phase. Participants who completed the study or discontinued the study early could have opted to enter the 14-week observational follow up.

Subject analysis set title

Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

Participants who received placebo in the placebo-controlled phase who entered the 14-week observational follow up.

Subject analysis set title

Apremilast 20 mg BID

Subject analysis set type

Safety analysis

Subject analysis set description

Participants who received apremilast 20 mg in either the placebo-controlled phase or apremilast extension phase who entered the 14-week observational follow up.

Subject analysis set title

Apremilast 30 mg BID

Subject analysis set type

Safety analysis

Subject analysis set description

Participants who received apremilast 30 mg in either the placebo-controlled phase or apremilast extension phase who entered the 14-week observational follow up.

Primary: Percentage of Participants with a Static Physician Global Assessment (sPGA) Response at Week 16

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End point title

Percentage of Participants with a Static Physician Global Assessment (sPGA) Response at Week 16

End point description

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

End point type

Primary

End point timeframe

Baseline to Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	82	163
Units: percentage of participants
number (not applicable)	11.5	33.1

Placebo vs. Apremilast

Comparison groups

Placebo v Apremilast

Number of subjects included in analysis

245

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Percentage Adjusted Difference

Point estimate

21.7

Confidence interval

level

95%

sides

2-sided

lower limit

11.2

upper limit

32.1

Secondary: Percentage of Participants who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) from Baseline at Week 16

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End point title

Percentage of Participants who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) from Baseline at Week 16

End point description

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

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	82	163
Units: percentage of participants
number (not applicable)	16.1	45.4

Placebo vs. Apremilast

Comparison groups

Placebo v Apremilast

Number of subjects included in analysis

245

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Percentage Adjusted Difference

Point estimate

29.4

Confidence interval

level

95%

sides

2-sided

lower limit

17.8

upper limit

40.9

Secondary: Percentage of Participants who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) from Baseline at Week 16

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End point title

Percentage of Participants who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) from Baseline at Week 16

End point description

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

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	82	163
Units: percentage of participants
number (not applicable)	32.1	70.5

Placebo vs. Apremilast

Comparison groups

Placebo v Apremilast

Number of subjects included in analysis

245

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Percentage Adjusted Difference

Point estimate

38.4

Confidence interval

level

95%

sides

2-sided

lower limit

25.6

upper limit

51.2

Secondary: Percentage Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16

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End point title

Percentage Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16

End point description

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

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	82	163
Units: percentage change in affected BSA
arithmetic mean (standard error)	-20.56 ( 5.441 )	-55.44 ( 3.428 )

Placebo vs. Apremilast

Comparison groups

Placebo v Apremilast

Number of subjects included in analysis

245

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

Difference in Least Squares Mean

Point estimate

-34.77

Confidence interval

level

95%

sides

2-sided

lower limit

-46.99

upper limit

-22.55

Variability estimate

Standard error of the mean

Dispersion value

6.229

Secondary: Percentage Change from Baseline in Total PASI Score at Week 16

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End point title

Percentage Change from Baseline in Total PASI Score at Week 16

End point description

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

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	82	163
Units: percentage change
arithmetic mean (standard error)	-37.49 ( 3.866 )	-64.52 ( 2.543 )

Placebo vs. Apremilast

Comparison groups

Placebo v Apremilast

Number of subjects included in analysis

245

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

Difference in Least Squares Mean

Point estimate

-26.97

Confidence interval

level

95%

sides

2-sided

lower limit

-35.93

upper limit

-18

Variability estimate

Standard error of the mean

Dispersion value

4.572

Secondary: Percentage of Participants who Achieved a Children’s Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16

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End point title

Percentage of Participants who Achieved a Children’s Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16

End point description

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. Measured in participants in the intent-to-treat (ITT) population (which included all participants who were randomized), with a baseline CDLQI Score >/= 2.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	76	148
Units: percentage of participants
number (not applicable)	31.3	35.4

Placebo vs. Apremilast

Comparison groups

Placebo v Apremilast

Number of subjects included in analysis

224

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5616

Method

Cochran-Mantel-Haenszel

Parameter type

Percentage Adjusted Difference

Point estimate

4.1

Confidence interval

level

95%

sides

2-sided

lower limit

-9.8

upper limit

Secondary: Change from Baseline in CDLQI Score at Week 16

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End point title

Change from Baseline in CDLQI Score at Week 16

End point description

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

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	82	163
Units: scores on a scale
arithmetic mean (standard error)	-2.7 ( 0.56 )	-5.3 ( 0.44 )

Placebo vs. Apremilast

Comparison groups

Placebo v Apremilast

Number of subjects included in analysis

245

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0009

Method

ANCOVA

Parameter type

Difference in Least Squares Mean

Point estimate

-1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-2.9

upper limit

-0.8

Variability estimate

Standard error of the mean

Dispersion value

0.55

Secondary: Number of Participants who Experienced a TEAE During the Apremilast Exposure Period

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End point title

Number of Participants who Experienced a TEAE During the Apremilast Exposure Period

End point description

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. 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.

End point type

Secondary

End point timeframe

52 weeks

End point values	Apremilast Exposure Period: Apremilast 20 mg BID	Apremilast Exposure Period: Apremilast 30 mg BID
Number of subjects analysed	116	119
Units: participants	88	80

No statistical analyses for this end point

Secondary: Number of Participants who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase

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End point title

Number of Participants who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase

End point description

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. 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.

End point type

Secondary

End point timeframe

16 weeks

End point values	Placebo	Apremilast 20 mg	Apremilast 30 mg
Number of subjects analysed	80	80	83
Units: participants	1	2	0

No statistical analyses for this end point

Secondary: Number of Participants who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase

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End point title

Number of Participants who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase

End point description

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. 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.

End point type

Secondary

End point timeframe

16 weeks

End point values	Placebo	Apremilast 20 mg	Apremilast 30 mg
Number of subjects analysed	80	80	83
Units: participants	33	58	48

No statistical analyses for this end point

Secondary: Number of Participants who Experienced a TRAE During the Apremilast Exposure Period

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End point title

Number of Participants who Experienced a TRAE During the Apremilast Exposure Period

End point description

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

End point type

Secondary

End point timeframe

52 weeks

End point values	Apremilast Exposure Period: Apremilast 20 mg BID	Apremilast Exposure Period: Apremilast 30 mg BID
Number of subjects analysed	116	119
Units: participants	45	47

No statistical analyses for this end point

Secondary: Number of Participants who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase

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End point title

Number of Participants who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase

End point description

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

End point type

Secondary

End point timeframe

16 weeks

End point values	Placebo	Apremilast 20 mg	Apremilast 30 mg
Number of subjects analysed	80	80	83
Units: participants	12	36	32

No statistical analyses for this end point

Secondary: Number of Participants who Experienced a TESAE During the Apremilast Exposure Period

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End point title

Number of Participants who Experienced a TESAE During the Apremilast Exposure Period

End point description

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. 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.

End point type

Secondary

End point timeframe

52 weeks

End point values	Apremilast Exposure Period: Apremilast 20 mg BID	Apremilast Exposure Period: Apremilast 30 mg BID
Number of subjects analysed	116	119
Units: participants	2	1

No statistical analyses for this end point

Secondary: Number of Participants with Diarrhea During the Placebo-controlled Phase

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End point title

Number of Participants with Diarrhea During the Placebo-controlled Phase

End point description

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. 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.

End point type

Secondary

End point timeframe

Up to approximately 113 days

End point values	Placebo	Apremilast
Number of subjects analysed	80	163
Units: participants
Day 1 to 28 (n=77,156)	25	67
Day 29 to 56 (n=73,155)	20	51
Day 57 to 84 (n=73,147)	14	41
Day 85 to 112 (n=69,142)	10	29
Day >/= 113 (n=46,105)	2	9

No statistical analyses for this end point

Secondary: Number of Participants with Diarrhea During the Apremilast Exposure Period

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End point title

Number of Participants with Diarrhea During the Apremilast Exposure Period

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 365 days

End point values	Apremilast Exposure Period: Apremilast 20 mg BID	Apremilast Exposure Period: Apremilast 30 mg BID
Number of subjects analysed	116	119
Units: participants
Day 1 to 28 (n=109, 114)	36	47
Day 29 to 56 (n= 108,103)	30	36
Day 57 to 84 (n=101, 110)	22	32
Day 85 to 112 (n=100,106)	17	19
Day 113 to 140 (n=99,106)	21	17
Day 141 to 168 (n=98,104)	16	21
Day 169 to 196 (n=96,102)	19	17
Day 197 to 224 (n=93,102)	19	12
Day 225 to 252 (n=92,98)	20	12
Day 253 to 280 (n=76,69)	18	16
Day 281 to 308 (n=61,60)	13	9
Day 309 to 336 (n=62,59)	12	5
Day 337 to 364 (n=59,58)	7	5
Day >= 365 (n=24,22)	1	1

No statistical analyses for this end point

Secondary: Number of Participants with Diarrhea Symptoms During the Placebo-controlled Phase

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End point title

Number of Participants with Diarrhea Symptoms During the Placebo-controlled Phase

End point description

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. 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.

End point type

Secondary

End point timeframe

Up to approximately 113 days

End point values	Placebo	Apremilast
Number of subjects analysed	80	163
Units: participants
Day 1 to 28\|Nausea (n=77,156)	3	32
Day 29 to 56\|Nausea (n=80,163)	2	22
Day 57 to 84\|Nausea (n=80,163)	1	12
Day 85 to 112\|Nausea (n=80,163)	2	8
Day >/= 113\|Nausea (n=80,163)	0	2
Day 1 to 28\|Vomiting (n=77,156)	2	13
Day 29 to 56\|Vomiting (n=80,163)	2	6
Day 57 to 84\|Vomiting (n=80,163)	0	7
Day 85 to 112\|Vomiting (n=80,163)	1	3
Day >/= 113\|Vomiting (n=80,163)	0	1
Day 1 to 28\|Abdominal cramps (n=77,156)	3	16
Day 29 to 56\|Abdominal cramps (n=80,163)	3	7
Day 57 to 84\|Abdominal cramps (n=80,163)	1	9
Day 85 to 112\|Abdominal cramps (n=80,163)	1	5
Day >/= 113\|Abdominal cramps (n=80,163)	0	1
Day 1 to 28\|Abdominal pain (n=77,156)	9	28
Day 29 to 56\|Abdominal pain (n=80,163)	9	17
Day 57 to 84\|Abdominal pain (n=80,163)	5	13
Day 85 to 112\|Abdominal pain (n=80,163)	2	7
Day >/= 113\|Abdominal pain (n=80,163)	0	2
Day 1 to 28\|Fever (n=77,156)	1	5
Day 29 to 56\|Fever (n=80,163)	0	1
Day 57 to 84\|Fever (n=80,163)	0	2
Day 85 to 112\|Fever (n=80,163)	0	2
Day >/= 113\|Fever (n=80,163)	0	0
Day 1 to 28\|Bloating (n=77,156)	1	8
Day 29 to 56\|Bloating (n=80,163)	4	12
Day 57 to 84\|Bloating (n=80,163)	2	6
Day 85 to 112\|Bloating (n=80,163)	3	5
Day >/= 113\|Bloating (n=80,163)	1	1
Day 1 to 28\|Other symptoms (n=77,156)	5	21
Day 29 to 56\|Other symptoms (n=80,163)	4	17
Day 57 to 84\|Other symptoms (n=80,163)	6	11
Day 85 to 112\|Other symptoms (n=80,163)	5	8
Day >/= 113\|Other symptoms (n=80,163)	0	2
Day 1 to 28\|No symptoms (n=77,156)	53	33
Day 29 to 56\|No symptoms (n=80,163)	56	81
Day 57 to 84\|No symptoms (n=80,163)	65	103
Day 85 to 112\|No symptoms (n=80,163)	66	125
Day >/= 113\|No symptoms (n=80,163)	79	154

No statistical analyses for this end point

Secondary: Number of Participants with Diarrhea Symptoms During the Apremilast Exposure Period

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End point title

Number of Participants with Diarrhea Symptoms During the Apremilast Exposure Period

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 365 days

End point values	Apremilast Exposure Period: Apremilast 20 mg BID	Apremilast Exposure Period: Apremilast 30 mg BID
Number of subjects analysed	116	119
Units: participants
Day 1 to 28\|Nausea (n=109,114)	17	21
Day 1 to 28\|Vomiting (n=109,114)	10	4
Day 1 to 28\|Abdominal cramps (n=109,114)	7	9
Day 1 to 28\|Abdominal pain (n=109,114)	21	14
Day 1 to 28\|Fever (n=109,114)	2	3
Day 1 to 28\|Bloating (n=109,114)	3	7
Day 1 to 28\|Other symptoms (n=109,114)	11	13
Day 1 to 28\|No symptoms (n=109,114)	38	43
Day 29 to 56\|Nausea (n=108,113)	14	10
Day 29 to 56\|Vomiting (n=108,113)	4	3
Day 29 to 56\|Abdominal cramps (n=108,113)	4	4
Day 29 to 56\|Abdominal pain (n=108,113)	13	8
Day 29 to 56\|Fever (n=108,113)	1	0
Day 29 to 56\|Bloating (n=108,113)	4	9
Day 29 to 56\|Other symptoms (n=108,113)	9	9
Day 29 to 56\|No symptoms (n=108,113)	59	70
Day 57 to 84\|Nausea (n=101,110)	6	8
Day 57 to 84\|Vomiting (n=101,110)	6	4
Day 57 to 84\|Abdominal cramps (n=101,110)	8	3
Day 57 to 84\|Abdominal pain (n=101,110)	10	6
Day 57 to 84\|Fever (n=101,110)	1	1
Day 57 to 84\|Bloating (n=101,110)	1	6
Day 57 to 84\|Other symptoms (n=101,110)	10	6
Day 57 to 84\|No symptoms (n=101,110)	59	76
Day 85 to 112\|Nausea (n=100,106)	3	5
Day 85 to 112\|Vomiting (n=100,106)	3	0
Day 85 to 112\|Abdominal cramps (n=100,106)	4	2
Day 85 to 112\|Abdominal pain (n=100,106)	6	3
Day 85 to 112\|Fever (n=100,106)	1	2
Day 85 to 112\|Bloating (n=100,106)	2	4
Day 85 to 112\|Other symptoms (n=100,106)	5	4
Day 85 to 112\|No symptoms (n=100,106)	76	86
Day 113 to 140\|Nausea (n=99,106)	6	2
Day 113 to 140\|Vomiting (n=99,106)	5	1
Day 113 to 140\|Abdominal cramps (n=99,106)	4	0
Day 113 to 140\| Abdominal pain (n=99,106)	7	3
Day 113 to 140\|Fever (n=99,106)	1	0
Day 113 to 140\|Bloating (n=99,106)	3	2
Day 113 to 140\|Other symptoms (n=99,106)	5	3
Day 113 to 140\|No symptoms (n=99,106)	68	95
Day 141 to 168\|Nausea (n=98,104)	5	2
Day 141 to 168\|Vomiting (n=98,104)	3	1
Day 141 to 168\|Abdominal cramps (n=98,104)	2	1
Day 141 to 168\|Abdominal pain (n=98,104)	4	2
Day 141 to 168\|Fever (n=98,104)	0	0
Day 141 to 168\|Bloating (n=98,104)	2	2
Day 141 to 168\|Other symptoms (n=98,104)	3	1
Day 141 to 168\|No symptoms (n=98,104)	79	95
Day 169 to 196\|Nausea (n=96,102)	3	4
Day 169 to 196\|Vomiting (n=96,102)	2	1
Day 169 to 196\|Abdominal cramps (n=96,102)	1	2
Day 169 to 196\|Abdominal pain (n=96,102)	7	5
Day 169 to 196\|Fever (n=96,102)	0	2
Day 169 to 196\|Bloating (n=96,102)	0	1
Day 169 to 196\|Other symptoms (n=96,102)	7	0
Day 169 to 196\|No symptoms (n=96,102)	76	87
Day 197 to 224\|Nausea (n=93,102)	5	2
Day 197 to 224\|Vomiting (n=93,102)	5	0
Day 197 to 224\|Abdominal cramps (n=93,102)	1	0
Day 197 to 224\|Abdominal pain (n=93,102)	3	1
Day 197 to 224\|Fever (n=93,102)	2	0
Day 197 to 224\|Bloating (n=93,102)	1	1
Day 197 to 224\|Other symptoms (n=93,102)	4	1
Day 197 to 224\|No symptoms (n=93,102)	72	97
Day 225 to 252\|Nausea (n=92,98)	9	3
Day 225 to 252\|Vomiting (n=92,98)	3	0
Day 225 to 252\|Abdominal cramps (n=92,98)	2	1
Day 225 to 252\|Abdominal pain (n=92,98)	7	1
Day 225 to 252\|Fever (n=92,98)	0	0
Day 225 to 252\|Bloating (n=92,98)	3	1
Day 225 to 252\|Other symptoms (n=92,98)	4	0
Day 225 to 252\|No symptoms (n=92,98)	64	92
Day 253 to 280\|Nausea (n=76,69)	5	4
Day 253 to 280\|Vomiting (n=76,69)	1	0
Day 253 to 280\|Abdominal cramps (n=76,69)	3	1
Day 253 to 280\|Abdominal pain (n=76,69)	6	3
Day 253 to 280\|Fever (n=76,69)	1	0
Day 253 to 280\|Bloating (n=76,69)	2	1
Day 253 to 280\|Other symptoms (n=76,69)	3	2
Day 253 to 280\|No symptoms (n=76,69)	55	58
Day 281 to 308\|Nausea (n=61,60)	2	3
Day 281 to 308\|Vomiting (n=61,60)	1	2
Day 281 to 308\|Abdominal cramps (n=61,60)	1	2
Day 281 to 308\|Abdominal pain (n=61,60)	4	2
Day 281 to 308\|Fever (n=61,60)	0	0
Day 281 to 308\|Bloating (n=61,60)	0	1
Day 281 to 308\|Other symptoms (n=61,60)	1	1
Day 281 to 308\|No symptoms (n=61,60)	52	49
Day 309 to 336\|Nausea(n=62,59)	2	1
Day 309 to 336\|Vomiting(n=62,59)	2	0
Day 309 to 336\|Abdominal cramps(n=62,59)	1	0
Day 309 to 336\|Abdominal pain(n=62,59)	4	0
Day 309 to 336\|Fever(n=62,59)	1	0
Day 309 to 336\|Bloating(n=62,59)	1	0
Day 309 to 336\|Other symptoms(n=62,59)	4	1
Day 309 to 336\|No symptoms(n=62,59)	47	57
Day 337 to 364\|Nausea(n=59,58)	2	1
Day 337 to 364\|Vomiting(n=59,58)	1	0
Day 337 to 364\|Abdominal cramps(n=59,58)	0	0
Day 337 to 364\|Abdominal pain(n=59,58)	2	2
Day 337 to 364\|Fever(n=59,58)	0	0
Day 337 to 364\|Bloating(n=59,58)	1	0
Day 337 to 364\|Other symptoms(n=59,58)	1	1
Day 337 to 364\|No symptoms(n=59,58)	52	54
Day >= 365\|Nausea (n=24,22)	0	0
Day >= 365\|Vomiting (n=24,22)	0	0
Day >= 365\|Abdominal cramps (n=24,22)	0	1
Day >= 365\|Abdominal pain (n=24,22)	0	0
Day >= 365\|Fever (n=24,22)	0	0
Day >= 365\|Bloating (n=24,22)	0	0
Day >= 365\|Other symptoms (n=24,22)	0	0
Day >= 365\|No symptoms (n=24,22)	24	21

No statistical analyses for this end point

Secondary: Number of Participants with Suicidal Ideation or Behavior per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase

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End point title

Number of Participants with Suicidal Ideation or Behavior per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase

End point description

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. Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

16 weeks

End point values	Placebo	Apremilast
Number of subjects analysed	80	163
Units: participants	0	0

No statistical analyses for this end point

Secondary: Number of Participants with Suicidal Ideation or Behavior per the C-SSRS During the Apremilast-extension Phase

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End point title

Number of Participants with Suicidal Ideation or Behavior per the C-SSRS During the Apremilast-extension Phase

End point description

End point type

Secondary

End point timeframe

Week 16 to Week 52

End point values	Apremilast-extension Phase: Apremilast 20 mg BID	Apremilast-extension Phase: Apremilast 30 mg BID
Number of subjects analysed	110	111
Units: participants	0	0

No statistical analyses for this end point

Secondary: Number of Female Participants at Stage I-V of Sexual Development per Tanner Staging of Sexual Development

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End point title

Number of Female Participants at Stage I-V of Sexual Development per Tanner Staging of Sexual Development

End point description

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. 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.

End point type

Secondary

End point timeframe

Week 52

End point values	Placebo	Apremilast
Number of subjects analysed	37	89
Units: participants
Breast Growth\|Stage 1	8	17
Pubic Hair Growth\|Stage 1	8	18
Other Changes\|Stage 1	8	18
Breast Growth\|Stage 2	3	9
Pubic Hair Growth\|Stage 2	3	9
Other Changes\|Stage 2	3	9
Breast Growth\|Stage 3	3	9
Pubic Hair Growth\|Stage 3	3	9
Other Changes\|Stage 3	3	12
Breast Growth\|Stage 4	6	20
Pubic Hair Growth\|Stage 4	6	18
Other Changes\|Stage 4	4	16
Breast Growth\|Stage 5	12	27
Pubic Hair Growth\|Stage 5	12	28
Other Changes\|Stage 5	12	26
Breast Growth\|Missing	5	7
Pubic Hair Growth\|Missing	5	7
Other Changes\|Missing	7	8

No statistical analyses for this end point

Secondary: Number of Male Participants at Stage I-V of Sexual Development per Tanner Staging of Sexual Development

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End point title

Number of Male Participants at Stage I-V of Sexual Development per Tanner Staging of Sexual Development

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	Placebo	Apremilast
Number of subjects analysed	43	74
Units: participants
Testes Growth\|Stage 1	11	15
Penis Growth\|Stage 1	11	15
Pubic Hair Growth\|Stage 1	10	15
Other Changes\|Stage 1	9	15
Testes Growth\|Stage 2	5	5
Penis Growth\|Stage 2	5	5
Pubic Hair Growth\|Stage 2	5	6
Other Changes\|Stage 2	5	5
Testes Growth\|Stage 3	4	10
Penis Growth\|Stage 3	4	11
Pubic Hair Growth\|Stage 3	5	8
Other Changes\|Stage 3	4	8
Testes Growth\|Stage 4	5	12
Penis Growth\|Stage 4	5	10
Pubic Hair Growth\|Stage 4	6	14
Other Changes\|Stage 4	4	11
Testes Growth\|Stage 5	14	27
Penis Growth\|Stage 5	14	28
Pubic Hair Growth\|Stage 5	13	26
Other Changes\|Stage 5	14	26
Testes Growth\|Missing	4	5
Penis Growth\|Missing	4	5
Pubic Hair Growth\|Missing	4	5
Other Changes\|Missing	7	9

No statistical analyses for this end point

Secondary: Mean Body Weight of Participants During the Placebo-controlled Phase

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End point title

Mean Body Weight of Participants During the Placebo-controlled Phase

End point description

The participants' body weight in kilograms (kg) was recorded. Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	80	163
Units: kg
arithmetic mean (standard deviation)
Baseline	52.36 ( 22.177 )	52.04 ( 21.123 )
Week 16	54.18 ( 22.581 )	51.95 ( 20.945 )

No statistical analyses for this end point

Secondary: Mean Body Weight of Participants During the Apremilast Exposure Period

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End point title

Mean Body Weight of Participants During the Apremilast Exposure Period

End point description

The participants' body weight in kilograms (kg) was recorded. Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

Baseline and Week 52

End point values	Apremilast Exposure Period: Apremilast 20 mg BID	Apremilast Exposure Period: Apremilast 30 mg BID
Number of subjects analysed	116	119
Units: kg
arithmetic mean (standard deviation)
Baseline	36.81 ( 8.954 )	67.94 ( 19.053 )
Week 52	39.04 ( 9.823 )	67.79 ( 18.889 )

No statistical analyses for this end point

Secondary: Mean Height of Participants During the Apremilast Exposure Period

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End point title

Mean Height of Participants During the Apremilast Exposure Period

End point description

The participants' height in centimeters (cm) was recorded. Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

Baseline and Week 52

End point values	Apremilast Exposure Period: Apremilast 20 mg BID	Apremilast Exposure Period: Apremilast 30 mg BID
Number of subjects analysed	116	119
Units: cm
arithmetic mean (standard deviation)
Baseline	140.86 ( 14.159 )	166.13 ( 11.416 )
Week 52	144.90 ( 13.944 )	167.84 ( 10.814 )

No statistical analyses for this end point

Secondary: Mean Height of Participants During the Placebo-controlled Phase

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End point title

Mean Height of Participants During the Placebo-controlled Phase

End point description

The participants' height in centimeters (cm) was recorded. Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	80	163
Units: cm
arithmetic mean (standard deviation)
Baseline	153.29 ( 18.435 )	153.33 ( 18.069 )
Week 16	154.54 ( 17.839 )	154.40 ( 17.683 )

No statistical analyses for this end point

Secondary: Mean BMI of Participants During the Apremilast Exposure Period

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End point title

Mean BMI of Participants During the Apremilast Exposure Period

End point description

The participants' BMI was calculated as body weight (kg)/height (m^2). Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

Baseline and Week 52

End point values	Apremilast Exposure Period: Apremilast 20 mg BID	Apremilast Exposure Period: Apremilast 30 mg BID
Number of subjects analysed	116	119
Units: kg/m^2
arithmetic mean (standard deviation)
Baseline	18.32 ( 2.641 )	24.52 ( 5.655 )
Week 52	18.30 ( 2.480 )	23.95 ( 5.539 )

No statistical analyses for this end point

Secondary: Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase

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End point title

Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase

End point description

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Placebo	Apremilast
Number of subjects analysed	80	163
Units: kg/m^2
arithmetic mean (standard deviation)
Baseline	21.41 ( 5.652 )	21.33 ( 5.197 )
Week 16	21.87 ( 5.883 )	20.98 ( 5.067 )

No statistical analyses for this end point

Secondary: Number of Participants who Experienced a Psoriasis Rebound

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End point title

Number of Participants who Experienced a Psoriasis Rebound

End point description

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. 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.

End point type

Secondary

End point 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)

End point values	Placebo	Apremilast 20 mg BID	Apremilast 30 mg BID
Number of subjects analysed	1	14	30
Units: participants	0	0	4

No statistical analyses for this end point

Secondary: Number of Participants who Experienced a Psoriasis Flare During the Placebo-controlled Phase

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End point title

Number of Participants who Experienced a Psoriasis Flare During the Placebo-controlled Phase

End point description

A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications. Measured in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

16 weeks

End point values	Placebo	Apremilast
Number of subjects analysed	80	163
Units: participants	3	2

No statistical analyses for this end point

Secondary: Number of Participants who Experienced a Psoriasis Flare During the Apremilast Exposure Period

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End point title

Number of Participants who Experienced a Psoriasis Flare During the Apremilast Exposure Period

End point description

End point type

Secondary

End point timeframe

52 weeks

End point values	Apremilast Exposure Period: Apremilast 20 mg BID	Apremilast Exposure Period: Apremilast 30 mg BID
Number of subjects analysed	116	119
Units: participants	7	11

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to a maximum of 52 weeks

Adverse event reporting additional description

All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety Population, which included all randomized participants who received at least 1 dose of investigational product. As pre-specified, data are presented per treatment received.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.1

Reporting group title

Placebo-Controlled Phase: Placebo BID

Reporting group description

Reporting group title

Placebo-Controlled Phase: Apremilast 20 mg BID

Reporting group description

Reporting group title

Placebo-Controlled Phase: Apremilast 30 mg BID

Reporting group description

Reporting group title

Apremilast Extension Phase: Apremilast 20 mg or 30 mg BID

Reporting group description

Reporting group title

Apremilast Extension Phase: Apremilast 20 mg BID

Reporting group description

Reporting group title

Apremilast Extension Phase: Apremilast 30 mg BID

Reporting group description

Reporting group title

Placebo-Controlled Phase: Apremilast 20 mg or 30 mg BID

Reporting group description

Serious adverse events	Placebo-Controlled Phase: Placebo BID	Placebo-Controlled Phase: Apremilast 20 mg BID	Placebo-Controlled Phase: Apremilast 30 mg BID	Apremilast Extension Phase: Apremilast 20 mg or 30 mg BID	Apremilast Extension Phase: Apremilast 20 mg BID	Apremilast Extension Phase: Apremilast 30 mg BID	Placebo-Controlled Phase: Apremilast 20 mg or 30 mg BID
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 80 (1.25%)	2 / 80 (2.50%)	0 / 83 (0.00%)	2 / 221 (0.90%)	0 / 110 (0.00%)	2 / 111 (1.80%)	2 / 163 (1.23%)
number of deaths (all causes)	0	0	0	0	0	0	0
number of deaths resulting from adverse events
Cardiac disorders
Sinus tachycardia
subjects affected / exposed	0 / 80 (0.00%)	1 / 80 (1.25%)	0 / 83 (0.00%)	0 / 221 (0.00%)	0 / 110 (0.00%)	0 / 111 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wandering pacemaker
subjects affected / exposed	0 / 80 (0.00%)	1 / 80 (1.25%)	0 / 83 (0.00%)	0 / 221 (0.00%)	0 / 110 (0.00%)	0 / 111 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Autonomic nervous system imbalance
subjects affected / exposed	0 / 80 (0.00%)	1 / 80 (1.25%)	0 / 83 (0.00%)	0 / 221 (0.00%)	0 / 110 (0.00%)	0 / 111 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Status migrainosus
subjects affected / exposed	0 / 80 (0.00%)	0 / 80 (0.00%)	0 / 83 (0.00%)	1 / 221 (0.45%)	0 / 110 (0.00%)	1 / 111 (0.90%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Iron deficiency anaemia
subjects affected / exposed	0 / 80 (0.00%)	1 / 80 (1.25%)	0 / 83 (0.00%)	0 / 221 (0.00%)	0 / 110 (0.00%)	0 / 111 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Testicular appendage torsion
subjects affected / exposed	1 / 80 (1.25%)	0 / 80 (0.00%)	0 / 83 (0.00%)	0 / 221 (0.00%)	0 / 110 (0.00%)	0 / 111 (0.00%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	0 / 80 (0.00%)	1 / 80 (1.25%)	0 / 83 (0.00%)	0 / 221 (0.00%)	0 / 110 (0.00%)	0 / 111 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 80 (0.00%)	0 / 80 (0.00%)	0 / 83 (0.00%)	1 / 221 (0.45%)	0 / 110 (0.00%)	1 / 111 (0.90%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo-Controlled Phase: Placebo BID	Placebo-Controlled Phase: Apremilast 20 mg BID	Placebo-Controlled Phase: Apremilast 30 mg BID	Apremilast Extension Phase: Apremilast 20 mg or 30 mg BID	Apremilast Extension Phase: Apremilast 20 mg BID	Apremilast Extension Phase: Apremilast 30 mg BID	Placebo-Controlled Phase: Apremilast 20 mg or 30 mg BID
Total subjects affected by non serious adverse events
subjects affected / exposed	26 / 80 (32.50%)	50 / 80 (62.50%)	41 / 83 (49.40%)	90 / 221 (40.72%)	52 / 110 (47.27%)	38 / 111 (34.23%)	91 / 163 (55.83%)
Nervous system disorders
Headache
subjects affected / exposed	4 / 80 (5.00%)	12 / 80 (15.00%)	5 / 83 (6.02%)	12 / 221 (5.43%)	7 / 110 (6.36%)	5 / 111 (4.50%)	17 / 163 (10.43%)
occurrences all number	4	16	5	18	9	9	21
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	1 / 80 (1.25%)	7 / 80 (8.75%)	3 / 83 (3.61%)	5 / 221 (2.26%)	4 / 110 (3.64%)	1 / 111 (0.90%)	10 / 163 (6.13%)
occurrences all number	1	7	8	5	4	1	15
Gastrointestinal disorders
Nausea
subjects affected / exposed	2 / 80 (2.50%)	15 / 80 (18.75%)	17 / 83 (20.48%)	28 / 221 (12.67%)	18 / 110 (16.36%)	10 / 111 (9.01%)	32 / 163 (19.63%)
occurrences all number	2	29	31	56	34	22	60
Diarrhoea
subjects affected / exposed	8 / 80 (10.00%)	15 / 80 (18.75%)	17 / 83 (20.48%)	33 / 221 (14.93%)	20 / 110 (18.18%)	13 / 111 (11.71%)	32 / 163 (19.63%)
occurrences all number	24	35	44	104	53	51	79
Abdominal pain
subjects affected / exposed	8 / 80 (10.00%)	23 / 80 (28.75%)	9 / 83 (10.84%)	19 / 221 (8.60%)	14 / 110 (12.73%)	5 / 111 (4.50%)	32 / 163 (19.63%)
occurrences all number	20	54	13	35	24	11	67
Abdominal pain upper
subjects affected / exposed	4 / 80 (5.00%)	5 / 80 (6.25%)	4 / 83 (4.82%)	5 / 221 (2.26%)	5 / 110 (4.55%)	0 / 111 (0.00%)	9 / 163 (5.52%)
occurrences all number	12	6	4	5	5	0	10
Vomiting
subjects affected / exposed	2 / 80 (2.50%)	16 / 80 (20.00%)	13 / 83 (15.66%)	22 / 221 (9.95%)	15 / 110 (13.64%)	7 / 111 (6.31%)	29 / 163 (17.79%)
occurrences all number	3	28	15	31	23	8	43
Dyspepsia
subjects affected / exposed	0 / 80 (0.00%)	3 / 80 (3.75%)	7 / 83 (8.43%)	4 / 221 (1.81%)	2 / 110 (1.82%)	2 / 111 (1.80%)	10 / 163 (6.13%)
occurrences all number	0	7	7	6	2	4	14
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	3 / 80 (3.75%)	0 / 80 (0.00%)	2 / 83 (2.41%)	16 / 221 (7.24%)	5 / 110 (4.55%)	11 / 111 (9.91%)	2 / 163 (1.23%)
occurrences all number	3	0	2	16	5	11	2
Infections and infestations
Influenza
subjects affected / exposed	1 / 80 (1.25%)	5 / 80 (6.25%)	2 / 83 (2.41%)	6 / 221 (2.71%)	4 / 110 (3.64%)	2 / 111 (1.80%)	7 / 163 (4.29%)
occurrences all number	1	5	2	7	4	3	7
Nasopharyngitis
subjects affected / exposed	3 / 80 (3.75%)	5 / 80 (6.25%)	5 / 83 (6.02%)	11 / 221 (4.98%)	8 / 110 (7.27%)	3 / 111 (2.70%)	10 / 163 (6.13%)
occurrences all number	3	5	5	14	11	3	10
COVID-19
subjects affected / exposed	5 / 80 (6.25%)	2 / 80 (2.50%)	3 / 83 (3.61%)	7 / 221 (3.17%)	4 / 110 (3.64%)	3 / 111 (2.70%)	5 / 163 (3.07%)
occurrences all number	5	2	3	7	4	3	5

More information

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Were there any global substantial amendments to the protocol? Yes

12 Apr 2019

- Added an inclusion criterion for baseline minimum allowable body mass index - Added a specific body mass index parameter as a reason for mandatory participant withdrawal - Revised hemoglobin ranges for participant eligibility - Added a note to contraception options to clarify options considered “highly effective contraception” may differ per local guidelines/regulations

23 Sep 2019

- Replaced depictions of investigational product blister card packaging to align with redesigned packaging - Added text informing of switch from blister card investigational product to bottles during the apremilast-extension phase - Revised platelet ranges for participant eligibility - Removed requirement for reporting of pregnancies of partners of male participants

01 May 2020

- References to Celgene were replaced with Amgen - Updated to align with Amgen Global Drug Safety and Amgen Product Complaint Reporting processes - Updated to include instructions for paper reporting of serious adverse events - Added Sample Serious Adverse Event Form, Pregnancy Notification Form, and Lactation Notification Form to align with Amgen processes

26 Aug 2021

- Reduced the study sample size from at least 230 randomized participants to at least 180 randomized participants - Updated the power calculations based on the change in sample size - Added language regarding reporting of serious adverse events

17 Dec 2021

- Reverted the study sample size from at least 180 randomized participants to the original protocol goal of at least 230 randomized participants - Updated the power calculations based on the change in sample size

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
19 Mar 2020	Effective 19 March 2020, screening and enrollment were temporarily paused at all participating countries/sites to limit potential COVID-19 exposure for study participants, sponsor employees, and staff at clinical study sites. In June 2020, Amgen made a decision to lift the pause on screening and enrollment, based on an assessment that took into account the state of the pandemic, the study design, participant safety, public health risks, the benefit-risk balance, and the burden on healthcare systems. After the pause was lifted, enrollment resumed over the following months in a staggered fashion across countries and study sites, depending on the status of COVID-19 regionally as well as local restrictions and guidance.	01 Jun 2020

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants with a Static Physician Global Assessment (sPGA) Response at Week 16

Primary: Percentage of Participants with a Static Physician Global Assessment (sPGA) Response at Week 16

Secondary: Percentage of Participants who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) from Baseline at Week 16

Secondary: Percentage of Participants who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) from Baseline at Week 16

Secondary: Percentage of Participants who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) from Baseline at Week 16

Secondary: Percentage of Participants who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) from Baseline at Week 16

Secondary: Percentage Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16

Secondary: Percentage Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16

Secondary: Percentage Change from Baseline in Total PASI Score at Week 16

Secondary: Percentage Change from Baseline in Total PASI Score at Week 16

Secondary: Percentage of Participants who Achieved a Children’s Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16

Secondary: Percentage of Participants who Achieved a Children’s Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16

Secondary: Change from Baseline in CDLQI Score at Week 16

Secondary: Change from Baseline in CDLQI Score at Week 16

Secondary: Number of Participants who Experienced a TEAE During the Apremilast Exposure Period

Secondary: Number of Participants who Experienced a TEAE During the Apremilast Exposure Period

Secondary: Number of Participants who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase

Secondary: Number of Participants who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase

Secondary: Number of Participants who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase

Secondary: Number of Participants who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase

Secondary: Number of Participants who Experienced a TRAE During the Apremilast Exposure Period

Secondary: Number of Participants who Experienced a TRAE During the Apremilast Exposure Period

Secondary: Number of Participants who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase

Secondary: Number of Participants who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase

Secondary: Number of Participants who Experienced a TESAE During the Apremilast Exposure Period

Secondary: Number of Participants who Experienced a TESAE During the Apremilast Exposure Period

Secondary: Number of Participants with Diarrhea During the Placebo-controlled Phase

Secondary: Number of Participants with Diarrhea During the Placebo-controlled Phase

Secondary: Number of Participants with Diarrhea During the Apremilast Exposure Period

Secondary: Number of Participants with Diarrhea During the Apremilast Exposure Period

Secondary: Number of Participants with Diarrhea Symptoms During the Placebo-controlled Phase

Secondary: Number of Participants with Diarrhea Symptoms During the Placebo-controlled Phase

Secondary: Number of Participants with Diarrhea Symptoms During the Apremilast Exposure Period

Secondary: Number of Participants with Diarrhea Symptoms During the Apremilast Exposure Period

Secondary: Number of Participants with Suicidal Ideation or Behavior per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase

Secondary: Number of Participants with Suicidal Ideation or Behavior per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase

Secondary: Number of Participants with Suicidal Ideation or Behavior per the C-SSRS During the Apremilast-extension Phase

Secondary: Number of Participants with Suicidal Ideation or Behavior per the C-SSRS During the Apremilast-extension Phase

Secondary: Number of Female Participants at Stage I-V of Sexual Development per Tanner Staging of Sexual Development

Secondary: Number of Female Participants at Stage I-V of Sexual Development per Tanner Staging of Sexual Development

Secondary: Number of Male Participants at Stage I-V of Sexual Development per Tanner Staging of Sexual Development

Secondary: Number of Male Participants at Stage I-V of Sexual Development per Tanner Staging of Sexual Development

Secondary: Mean Body Weight of Participants During the Placebo-controlled Phase

Secondary: Mean Body Weight of Participants During the Placebo-controlled Phase

Secondary: Mean Body Weight of Participants During the Apremilast Exposure Period

Secondary: Mean Body Weight of Participants During the Apremilast Exposure Period

Secondary: Mean Height of Participants During the Apremilast Exposure Period

Secondary: Mean Height of Participants During the Apremilast Exposure Period

Secondary: Mean Height of Participants During the Placebo-controlled Phase

Secondary: Mean Height of Participants During the Placebo-controlled Phase

Secondary: Mean BMI of Participants During the Apremilast Exposure Period

Secondary: Mean BMI of Participants During the Apremilast Exposure Period

Secondary: Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase

Secondary: Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase

Secondary: Number of Participants who Experienced a Psoriasis Rebound

Secondary: Number of Participants who Experienced a Psoriasis Rebound

Secondary: Number of Participants who Experienced a Psoriasis Flare During the Placebo-controlled Phase

Secondary: Number of Participants who Experienced a Psoriasis Flare During the Placebo-controlled Phase

Secondary: Number of Participants who Experienced a Psoriasis Flare During the Apremilast Exposure Period

Secondary: Number of Participants who Experienced a Psoriasis Flare During the Apremilast Exposure Period

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis