Trial Outcomes & Findings for A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy (NCT NCT03930186)

Last Updated: 2022-01-20

Results Overview

The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe. The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

152 participants

Primary outcome timeframe

Week 16

Results posted on

2022-01-20

Participant Flow

This study was conducted at 28 centers in Japan.

Participant milestones

Participant milestones
Measure	Apremilast Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Weeks 0 to 16 STARTED	152
Weeks 0 to 16 Received Study Drug	152
Weeks 0 to 16 COMPLETED	140
Weeks 0 to 16 NOT COMPLETED	12
Weeks 16 to 32 STARTED	140
Weeks 16 to 32 COMPLETED	136
Weeks 16 to 32 NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Apremilast Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Weeks 0 to 16 Adverse Event	6
Weeks 0 to 16 Withdrawal by Subject	6
Weeks 16 to 32 Adverse Event	1
Weeks 16 to 32 Withdrawal by Subject	3

Baseline Characteristics

A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Age, Continuous	48.0 years STANDARD_DEVIATION 11.90 • n=5 Participants
Age, Customized < 65 years	137 Participants n=5 Participants
Age, Customized ≥ 65 to < 75 years	14 Participants n=5 Participants
Age, Customized ≥ 75 years	1 Participants n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants
Race/Ethnicity, Customized Asian	152 Participants n=5 Participants
Duration of Plaque Psoriasis	11.94 years STANDARD_DEVIATION 10.629 • n=5 Participants
Body Surface Area (BSA) Affected by Psoriasis	13.40 percentage of total body surface area STANDARD_DEVIATION 11.491 • n=5 Participants
Static Physician's Global Assessment (sPGA) Score 0 (Clear)	0 Participants n=5 Participants
Static Physician's Global Assessment (sPGA) Score 1 (Almost Clear)	0 Participants n=5 Participants
Static Physician's Global Assessment (sPGA) Score 2 (Mild)	51 Participants n=5 Participants
Static Physician's Global Assessment (sPGA) Score 3 (Moderate)	101 Participants n=5 Participants
Static Physician's Global Assessment (sPGA) Score 4 (Severe)	0 Participants n=5 Participants
Scalp Physicians Global Assessment (ScPGA) 0 (Clear)	17 Participants n=5 Participants
Scalp Physicians Global Assessment (ScPGA) 1 (Almost Clear)	7 Participants n=5 Participants
Scalp Physicians Global Assessment (ScPGA) 2 (Mild)	63 Participants n=5 Participants
Scalp Physicians Global Assessment (ScPGA) 3 (Moderate)	63 Participants n=5 Participants
Scalp Physicians Global Assessment (ScPGA) 4 (Severe)	2 Participants n=5 Participants
Baseline Psoriasis Area Severity Index (PASI) Score	8.92 scores on a scale STANDARD_DEVIATION 5.383 • n=5 Participants
Pruritus Visual Analog Scale (VAS) Score	37.74 mm STANDARD_DEVIATION 25.257 • n=5 Participants
Baseline NAPSI Score for the Target Nail	1.53 scores on a scale STANDARD_DEVIATION 2.003 • n=5 Participants
Dermatology Life Quality Index (DLQI) Score	4.63 scores on a scale STANDARD_DEVIATION 3.902 • n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: The enrolled population; missing values through week 16 were imputed using the multiple imputation (MI) method.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16	43.7 percentage of participants Interval 35.72 to 51.66

SECONDARY outcome

Timeframe: Week 32

Population: The enrolled population; missing values through week 32 were imputed using non-responder imputation.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32	40.8 percentage of participants Interval 32.98 to 48.6

SECONDARY outcome

Timeframe: Weeks 16 and 32

Population: The enrolled population with Baseline ScPGA Score ≥ 2; missing values were imputed using non-responder imputation.

The ScPGA assesses scalp involvement of psoriasis based on scalp plaque elevation, scaling, and erythema. The 5-point ScPGA scale ranges from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe).

Outcome measures

Outcome measures
Measure	Apremilast n=128 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32 Week 16	52.3 percentage of participants Interval 43.69 to 61.0
Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32 Week 32	50.8 percentage of participants Interval 42.12 to 59.44

SECONDARY outcome

Timeframe: Baseline and weeks 16 and 32

Population: The enrolled population with available data at each time point

The overall body surface area affected by psoriasis was estimated based on the palm area of the participant's hand, which equates to approximately 1% of total body surface area. BSA affected by psoriasis is expressed as a percentage of total body surface area. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32 Week 16	-7.86 percent BSA Standard Deviation 8.755
Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32 Week 32	-8.32 percent BSA Standard Deviation 9.478

SECONDARY outcome

Timeframe: Baseline and weeks 2, 16, and 32

Population: The enrolled population with available data at each time point

Participants were asked to indicate how much itch they have had due to psoriasis in the past week by placing a vertical stroke on a 100 mm line on which the left-hand boundary (0 mm) represented no itch, and the right-hand boundary (100 mm) represented worst itch imaginable. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32 Week 2	-36.96 percent change Standard Deviation 46.474
Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32 Week 16	-28.05 percent change Standard Deviation 118.300
Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32 Week 32	-25.29 percent change Standard Deviation 122.113

SECONDARY outcome

Timeframe: Baseline and weeks 2, 16, and 32

Population: The enrolled population with available data at each time point

Shiratori's Pruritus Severity Score is a pruritus (itchiness) severity assessment tool used in Japan. Daytime and nighttime pruritus were evaluated and scored separately. Daytime pruritus was rated on a five-grade scale: 0 (absent), 1 (endurable without scratching; minimal), 2 (subsides with slight scratching; mild), 3 (subsides with considerable scratching; moderate), or 4 (not subsiding with scratching, which prompts repeated scratching; severe). Nighttime pruritus was rated on a five-grade scale: 0 (absent), 1 (slight itching at bedtime but not causing intentional scratching; no difficulty sleeping because of pruritus), 2 (slight itching that subsides with scratching; no difficulty sleeping because of pruritus), 3 (difficulty sleeping because of pruritus that resolves with scratching; unconscious scratching occurs during sleep), or 4 (severe difficulty sleeping due to pruritus; frequent scratching that worsens pruritus). A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32 Daytime: Week 2	-0.5 units on a scale Standard Deviation 0.77
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32 Daytime: Week 16	-0.7 units on a scale Standard Deviation 0.95
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32 Nighttime: Week 2	-0.4 units on a scale Standard Deviation 0.85
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32 Nighttime: Week 16	-0.7 units on a scale Standard Deviation 0.86
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32 Nighttime: Week 32	-0.7 units on a scale Standard Deviation 0.91
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32 Daytime: Week 32	-0.7 units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: Weeks 16 and 32

Population: The enrolled population with Baseline NAPSI Score ≥ 1; missing data were imputed using non-responder imputation.

One target thumb nail or fingernail representing the worst nail psoriasis involvement was selected for assessment at Baseline. The nail matrix was assessed for presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling) graded on a scale of 0 (none) to 4 (present in all 4 quadrants). The nail bed was assessed for the presence of any nail bed features (onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma) on a scale from 0 (none) to 4 (present in all quadrants). The sum of the nail matrix and nail bed scores is the total score and ranges from 0 to 8 (worst).

Outcome measures

Outcome measures
Measure	Apremilast n=76 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline Week 16	44.7 percentage of participants Interval 33.56 to 55.92
Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline Week 32	57.9 percentage of participants Interval 46.79 to 68.99

SECONDARY outcome

Timeframe: Baseline and weeks 16 and 32

Population: The enrolled population with available data at each time point

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much), except for Question 7, which first asks whether the participant's skin prevented them from working or studying (Yes (score = 3) or No (score = 0), then If "No", the participant is asked how much their skin was a problem at work or studying over the last week, with responses from 0 (not at all), 1 (a little), or 2 (a lot). The DLQI total score ranges from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32 Week 16	-2.2 scores on a scale Standard Deviation 2.96
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32 Week 32	-2.3 scores on a scale Standard Deviation 2.97

SECONDARY outcome

Timeframe: Baseline and weeks 16 and 32

Population: The enrolled population with available data at each time point

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. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32 Week 16	-69.61 percent change Standard Deviation 22.896
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32 Week 32	-69.48 percent change Standard Deviation 25.421

SECONDARY outcome

Timeframe: Weeks 16 and 32

Population: The enrolled population; missing values were imputed using non-responder imputation.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75) Week 16	43.4 percentage of participants Interval 35.54 to 51.3
Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75) Week 32	46.7 percentage of participants Interval 38.78 to 54.64

SECONDARY outcome

Timeframe: Weeks 16 and 32

Population: The enrolled population; missing data was imputed using non-responder imputation.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50) Week 16	79.6 percentage of participants Interval 73.2 to 86.01
Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50) Week 32	75.0 percentage of participants Interval 68.12 to 81.88

SECONDARY outcome

Timeframe: Baseline and weeks 16 and 32

Population: The enrolled population with available data at each time point

The Treatment Satisfaction Questionnaire for Medication (TSQM) version II is a self-administered instrument to understand a participant's satisfaction on current therapy. The TSQM comprises 11 items across 4 domains focusing on effectiveness (Item 1 and 2), side effects (Item 4 to 6), convenience (Item 7 to 9), and global satisfaction (Item 10 and 11). With the exception of Item 3 (experience any side effects; yes or no), all items have five or seven responses. Item scores are summed to give four domain scores, which are in turn transformed to a scale from 0 (extremely dissatisfied) to 100 (extremely satisfied).

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Effectiveness: Baseline	52.25 scores on a scale Standard Deviation 17.553
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Effectiveness: Week 16	67.41 scores on a scale Standard Deviation 21.176
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Effectiveness: Week 32	68.93 scores on a scale Standard Deviation 19.067
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Side Effects: Baseline	97.37 scores on a scale Standard Deviation 10.078
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Side Effects: Week 16	90.40 scores on a scale Standard Deviation 17.714
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Side Effects: Week 32	93.21 scores on a scale Standard Deviation 14.947
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Convenience: Baseline	56.43 scores on a scale Standard Deviation 16.735
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Convenience: Week 16	70.34 scores on a scale Standard Deviation 17.201
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Convenience: Week 32	70.48 scores on a scale Standard Deviation 16.527
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Global Satisfaction: Baseline	55.43 scores on a scale Standard Deviation 18.554
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Global Satisfaction: Week 16	71.21 scores on a scale Standard Deviation 18.241
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Global Satisfaction: Week 32	70.71 scores on a scale Standard Deviation 18.660

SECONDARY outcome

Timeframe: Weeks 16 and 32

Population: The enrolled population; missing data was imputed using non-responder imputation.

The Patient Benefit Index (PBI) is used to assess patient-relevant benefits of psoriasis treatment as a function of the most important needs identified by the participant before the start of treatment. Participants were asked to assess the benefits of treatment by completing the Patient Benefit Questionnaire (PBQ), which consists of 25 treatment goal statements scored from 0 (not at all) to 4 (very). The PBI is calculated for each participant by weighing the achievement values of each statement by their importance to the individual patient as assessed prior to the start of treatment. The PBI ranges from 0 (no benefit) to 4 (maximum benefit).

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32 Week 16	91.4 percentage of participants Interval 87.0 to 95.89
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32 Week 32	88.2 percentage of participants Interval 83.02 to 93.29

SECONDARY outcome

Timeframe: From first dose of study drug until at least 28 days after last dose; up to 36 weeks.

Population: The safety population included all participants who received at least 1 dose of study drug.

The Investigator assessed the severity/intensity of each adverse event as: Mild (asymptomatic or mild symptoms; intervention not indicated; activities of daily life (ADLs) minimally or not affected); Moderate (symptom(s) cause moderate discomfort; local or noninvasive intervention indicated; more than minimal interference with ADLs but able to carry out daily social and functional activities; drug therapy may be required); Severe (symptoms causing severe discomfort/pain; symptoms requiring medical/surgical attention/intervention; interference with ADLs including inability to perform daily social and functional activities; drug therapy required). A serious adverse event is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event.

Outcome measures

Outcome measures
Measure	Apremilast n=152 Participants Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Drug-related TEAE	88 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Severe TEAE	4 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Serious TEAE	4 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Severe drug-related TEAE	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Serious drug-related TEAE	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) TEAE leading to drug interruption	3 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) TEAE leading to drug withdrawal	7 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) TEAE leading to death	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any treatment-emergent adverse event	115 Participants

Adverse Events

Apremilast 30 mg

Serious events: 4 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Apremilast 30 mg n=152 participants at risk Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Ear and labyrinth disorders Deafness unilateral	0.66% 1/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Infections and infestations Gastroenteritis	0.66% 1/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.66% 1/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Investigations Blood creatine phosphokinase increased	0.66% 1/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Psychiatric disorders Depression	0.66% 1/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.

Other adverse events

Other adverse events
Measure	Apremilast 30 mg n=152 participants at risk Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Gastrointestinal disorders Diarrhoea	19.1% 29/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Gastrointestinal disorders Faeces soft	13.2% 20/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Gastrointestinal disorders Nausea	19.1% 29/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Infections and infestations Nasopharyngitis	18.4% 28/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Nervous system disorders Headache	13.2% 20/152 • From first dose of study drug until at least 28 days after last dose; up to 36 weeks.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER