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Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects with Moderate to Severe Genital Psoriasis

Summary
EudraCT number	2018-002608-15
Trial protocol	FR BE IT
Global end of trial date	09 Feb 2022

Results information
Results version number	v1(current)
This version publication date	15 Dec 2022
First version publication date	15 Dec 2022
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-PSOR-025

ISRCTN number

US NCT number

NCT03777436

WHO universal trial number (UTN)

Sponsor organisation name

Amgen Inc.

Sponsor organisation address

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

Public contact

Study Director, Amgen Inc., +1 866-572-6436, medinfo@amgen.com

Scientific contact

Study Director, Amgen Inc., +1 866-572-6436, 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?

Analysis stage

Final

Date of interim/final analysis

09 Feb 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

09 Feb 2022

Was the trial ended prematurely?

Main objective of the trial

The primary objective of the study was to evaluate the clinical efficacy of oral apremilast 30 mg twice daily (BID), compared to placebo, in participants with moderate to severe genital psoriasis during the 16-week Placebo-controlled Phase.

Protection of trial subjects

This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and in accordance with the general ethical principles outlined in the Declaration of Helsinki. Essential documents will be retained in accordance with ICH GCP. The study sponsor declares that the information provided in this report is an accurate representation of the data captured and analyses performed for this study.

Background therapy

Evidence for comparator

Actual start date of recruitment

11 Feb 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 7

Country: Number of subjects enrolled

Canada: 45

Country: Number of subjects enrolled

Germany: 66

Country: Number of subjects enrolled

France: 11

Country: Number of subjects enrolled

Italy: 19

Country: Number of subjects enrolled

United States: 141

Worldwide total number of subjects

289

EEA total number of subjects

103

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)

Adolescents (12-17 years)

Adults (18-64 years)

255

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants were enrolled at 49 centers in Belgium, Canada, France, Germany, Italy, and the United States from February 2019 to February 2022.

Screening details

Participants were randomized in a 1:1 ratio to receive either apremilast or matched placebo for the first 16 weeks (Placebo-controlled Phase) of the study. At Week 16, eligible participants may have continued on active treatment by entering a 16-week extension phase (Apremilast Extension Phase). Total treatment duration = 32 weeks.

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-controlled Phase: Placebo

Arm description

Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).

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

Administered orally.

Placebo-controlled Phase: Apremilast 30 mg

Arm description

Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).

Arm type

Experimental

Investigational medicinal product name

Apremilast

Investigational medicinal product code

CC-10004

Other name

Otezla

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Administered orally.

Number of subjects in period 1	Placebo-controlled Phase: Placebo	Placebo-controlled Phase: Apremilast 30 mg
Started	146	143
Took at Least 1 Dose of IP	145	143
Completed	111	119
Not completed	35	24
Consent withdrawn by subject	19	3
Physician decision	-	1
Due to COVID-19 control measures	1	-
Adverse event, non-fatal	8	10
Non-compliance with study drug	-	2
Lost to follow-up	7	7
Lack of efficacy	-	1

Period 2 title

Apremilast Extension Phase

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Apremilast Extension Phase: Apremilast 30 mg

Arm description

Eligible participants who completed the Placebo-controlled Phase entered the Apremilast Extension Phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).

Arm type

Experimental

Investigational medicinal product name

Apremilast

Investigational medicinal product code

CC-10004

Other name

Otezla

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Administered orally.

Number of subjects in period 2 ^[1]	Apremilast Extension Phase: Apremilast 30 mg
Started	229
Took at Least 1 Dose of IP	228
Completed	201
Not completed	28
Consent withdrawn by subject	13
Adverse event, non-fatal	6
Miscellaneous	1
Lost to follow-up	7
Lack of efficacy	1

Notes
[1] - 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: 1 participant did not enter the Apremilast Extension Phase as they were lost to follow-up.

Baseline characteristics

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Reporting group title

Placebo-controlled Phase: Placebo

Reporting group description

Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).

Reporting group title

Placebo-controlled Phase: Apremilast 30 mg

Reporting group description

Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).

Reporting group values	Placebo-controlled Phase: Placebo	Placebo-controlled Phase: Apremilast 30 mg	Total
Number of subjects	146	143	289
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	46.4 ± 14.38	43.5 ± 13.36	-
Sex: Female, Male
Units:
Female	44	43	87
Male	102	100	202
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0
Asian	8	4	12
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	3	6	9
White	131	131	262
More than one race	0	0	0
Unknown or Not Reported	3	2	5
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	13	18	31
Not Hispanic or Latino	131	125	256
Unknown or Not Reported	2	0	2
Modified Static Physician Global Assessment of Genitalia (sPGA-G) Score
The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions’ overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the three primary signs of the disease: erythema, plaque elevation, and scaling.
Units: Subjects
3 (Moderate)	128	123	251
4 (Severe)	18	20	38

End points

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Reporting group title

Placebo-controlled Phase: Placebo

Reporting group description

Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).

Reporting group title

Placebo-controlled Phase: Apremilast 30 mg

Reporting group description

Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).

Reporting group title

Apremilast Extension Phase: Apremilast 30 mg

Reporting group description

Primary: Percentage of Participants With a Modified sPGA-G Response at Week 16

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End point title

Percentage of Participants With a Modified sPGA-G Response at Week 16

End point description

The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions’ overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling. A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16. Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method. The intent-to-treat (ITT) analysis set consisted of all participants who are randomized regardless of whether the participant received investigational product (IP).

End point type

Primary

End point timeframe

Baseline and Week 16 of the Placebo-controlled Phase

End point values	Placebo-controlled Phase: Placebo	Placebo-controlled Phase: Apremilast 30 mg
Number of subjects analysed	146	143
Units: Percentage of participants
number (confidence interval 95%)	19.1 (12.4 to 25.7)	38.7 (30.4 to 47.0)

Placebo versus (vs.) Apremilast 30 mg

Comparison groups

Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg

Number of subjects included in analysis

289

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0003

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted difference

Point estimate

19.6

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

30.3

Secondary: 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 at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 3 (moderate) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16. Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method. The ITT analysis set consisted of all participants who are randomized regardless of whether the participant received IP.

End point type

Secondary

End point timeframe

Baseline and Week 16 of the placebo-controlled phase

End point values	Placebo-controlled Phase: Placebo	Placebo-controlled Phase: Apremilast 30 mg
Number of subjects analysed	146	143
Units: Percentage of participants
number (confidence interval 95%)	7.2 (2.9 to 11.5)	21.5 (14.4 to 28.5)

Placebo vs. Apremilast 30 mg

Comparison groups

Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg

Number of subjects included in analysis

289

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0007

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted difference

Point estimate

14.3

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

22.5

Secondary: Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16

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End point title

Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16

End point description

The GPI-NRS is a self-reported measure where participants were asked to assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch. A GPI-NRS response is defined as ≥ 4 point reduction (improvement) from Baseline. Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method. ITT analysis set with Baseline GPI-NRS score ≥ 4.

End point type

Secondary

End point timeframe

Baseline and Week 16 of the placebo-controlled phase

End point values	Placebo-controlled Phase: Placebo	Placebo-controlled Phase: Apremilast 30 mg
Number of subjects analysed	121	122
Units: Percentage of participants
number (confidence interval 95%)	19.6 (12.2 to 27.0)	46.0 (36.8 to 55.3)

Placebo vs. Apremilast 30 mg

Comparison groups

Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg

Number of subjects included in analysis

243

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted difference

Point estimate

26.2

Confidence interval

level

95%

sides

2-sided

lower limit

14.5

upper limit

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

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End point title

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

End point description

The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total BSA). A negative change from Baseline indicates a reduction of affected BSA. Based on mixed-effect model for repeated measures (MMRM) model. ITT analysis set with Baseline and at least one post-baseline value at Week 16.

End point type

Secondary

End point timeframe

Baseline and Week 16 of the placebo-controlled phase

End point values	Placebo-controlled Phase: Placebo	Placebo-controlled Phase: Apremilast 30 mg
Number of subjects analysed	111	120
Units: Change in percentage of affected BSA
least squares mean (standard error)	-0.79 ± 0.669	-4.12 ± 0.664

Placebo vs. Apremilast 30 mg

Comparison groups

Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg

Number of subjects included in analysis

231

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0005

Method

MMRM

Parameter type

Least squares mean difference

Point estimate

-3.33

Confidence interval

level

95%

sides

2-sided

lower limit

-5.18

upper limit

-1.47

Variability estimate

Standard error of the mean

Dispersion value

0.942

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

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End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

End point description

The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being 0 (not at all), 1 (a little) and 2 (a lot). Total scores have a possible range of 0-30, where 0 represents the best score, and 30 represents the worst health-related quality of life. A negative change from Baseline indicates an improvement in health-related quality of life scores. Based on MMRM model. ITT analysis set with Baseline and at least one post-baseline value at Week 16.

End point type

Secondary

End point timeframe

Baseline and Week 16 of the placebo-controlled phase

End point values	Placebo-controlled Phase: Placebo	Placebo-controlled Phase: Apremilast 30 mg
Number of subjects analysed	107	117
Units: Scores on a scale
least squares mean (standard error)	-2.6 ± 0.57	-5.3 ± 0.55

Placebo vs. Apremilast 30 mg

Comparison groups

Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg

Number of subjects included in analysis

224

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0008

Method

MMRM

Parameter type

Least squares mean difference

Point estimate

-2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4.2

upper limit

-1.1

Variability estimate

Standard error of the mean

Dispersion value

0.79

Secondary: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16

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End point title

Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16

End point description

The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no, and 10 represents the worst imaginable. Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms). A negative change from Baseline indicates an improvement in genital psoriasis symptoms. Based on MMRM model. ITT analysis set with Baseline and at least one post-baseline value at Week 16.

End point type

Secondary

End point timeframe

Baseline and Week 16 of the placebo-controlled phase

End point values	Placebo-controlled Phase: Placebo	Placebo-controlled Phase: Apremilast 30 mg
Number of subjects analysed	107	116
Units: Score on a scale
least squares mean (standard error)	-5.3 ± 1.85	-20.5 ± 1.83

Placebo vs. Apremilast 30 mg

Comparison groups

Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg

Number of subjects included in analysis

223

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

MMRM

Parameter type

Difference

Point estimate

-15.1

Confidence interval

level

95%

sides

2-sided

lower limit

-20.3

upper limit

-10

Variability estimate

Standard error of the mean

Dispersion value

2.6

Adverse events

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Timeframe for reporting adverse events

Up to a maximum of 41.4 weeks

Adverse event reporting additional description

The safety analysis set consisted of all participants who were randomized and received at least one dose of IP.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Placebo-controlled Phase: Placebo

Reporting group description

Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).

Reporting group title

Apremilast Extension Phase: Apremilast 30 mg

Reporting group description

Reporting group title

Placebo-controlled Phase: Apremilast 30 mg

Reporting group description

Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).

Serious adverse events	Placebo-controlled Phase: Placebo	Apremilast Extension Phase: Apremilast 30 mg	Placebo-controlled Phase: Apremilast 30 mg
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 145 (1.38%)	2 / 229 (0.87%)	3 / 143 (2.10%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	1 / 145 (0.69%)	0 / 229 (0.00%)	0 / 143 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 145 (0.00%)	0 / 229 (0.00%)	1 / 143 (0.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Actinic keratosis
subjects affected / exposed	0 / 145 (0.00%)	1 / 229 (0.44%)	0 / 143 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	0 / 145 (0.00%)	0 / 229 (0.00%)	1 / 143 (0.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 145 (0.00%)	1 / 229 (0.44%)	0 / 143 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	1 / 145 (0.69%)	0 / 229 (0.00%)	0 / 143 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 145 (0.69%)	0 / 229 (0.00%)	0 / 143 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	0 / 145 (0.00%)	0 / 229 (0.00%)	1 / 143 (0.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 145 (0.69%)	0 / 229 (0.00%)	0 / 143 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 145 (0.69%)	0 / 229 (0.00%)	0 / 143 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Placebo-controlled Phase: Placebo	Apremilast Extension Phase: Apremilast 30 mg	Placebo-controlled Phase: Apremilast 30 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	39 / 145 (26.90%)	53 / 229 (23.14%)	73 / 143 (51.05%)
Nervous system disorders
Headache
subjects affected / exposed	16 / 145 (11.03%)	15 / 229 (6.55%)	33 / 143 (23.08%)
occurrences all number	18	18	41
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	12 / 145 (8.28%)	27 / 229 (11.79%)	37 / 143 (25.87%)
occurrences all number	13	28	38
Nausea
subjects affected / exposed	11 / 145 (7.59%)	17 / 229 (7.42%)	32 / 143 (22.38%)
occurrences all number	12	17	32
Infections and infestations
Nasopharyngitis
subjects affected / exposed	12 / 145 (8.28%)	11 / 229 (4.80%)	12 / 143 (8.39%)
occurrences all number	13	14	14

More information

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Were there any global substantial amendments to the protocol? Yes

22 May 2019

- Specified that use of strong cytochrome P450 3A4 (CYP3A4) enzyme inducers is not recommended during the study. - Specified prohibitive concomitant use of antifungal and antiseptic treatment in the genital area. - Removed blinded language in reference to the apremilast extension phase and added dispensation of IP bottles at Week 20.

01 May 2020

- Updated to reflect the change in sponsor from Celgene to Amgen. - Updated safety reporting and product complaints information to align with Amgen processes.

03 Mar 2021

- Specified that the strata with BSA ≥ 10% would be ≥ 40% of the total enrollment (and the strata with BSA < 10% would comprise ≤ 60% of the total enrollment). - Updated the sample size from approximately 332 participants to approximately 286 participants. - Updated the power calculation based on the change in sample size.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
01 Apr 2020	In April 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.	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, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects with Moderate to Severe Genital Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With a Modified sPGA-G Response at Week 16

Primary: Percentage of Participants With a Modified sPGA-G Response at Week 16

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

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

Secondary: Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16

Secondary: Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16

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

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

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16

Secondary: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
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Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
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Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects with Moderate to Severe Genital Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With a Modified sPGA-G Response at Week 16

Primary: Percentage of Participants With a Modified sPGA-G Response at Week 16

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

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

Secondary: Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16

Secondary: Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16

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

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

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16

Secondary: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects with Moderate to Severe Genital Psoriasis