Trial Outcomes & Findings for Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy (NCT NCT03000309)

NCT ID: NCT03000309

Last Updated: 2019-03-28

Results Overview

The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) of disease severity is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2019-03-28

Participant Flow

Participant milestones

Measure	Apremilast Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy

Baseline characteristics by cohort

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Age, Continuous	55 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized black	2 Participants n=5 Participants
Race/Ethnicity, Customized white	18 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) of disease severity is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16	-9 score on a scale Standard Deviation 10

PRIMARY outcome

Timeframe: Week 16

The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0(no disease) and 500 (most severe disease.) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Percent Change in Product of BSA and sPGA	-44 percent change Standard Deviation 52

SECONDARY outcome

Timeframe: Week 8

The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. Th3 product of these values offers a more specific assessment of the severity of psoriasis. This product may yield a result between 0 (no disease) and 500 (most severe disease.)

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Percent Change in Product of BSA and sPGA	-29 percent change Standard Deviation 36

SECONDARY outcome

Timeframe: Week 8

The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Mean Change in DLQI	-6 score on a scale Standard Deviation 5

SECONDARY outcome

Timeframe: Week 16

The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Mean Change in DLQI	-7 units on a scale Standard Deviation 5

SECONDARY outcome

Timeframe: Baseline to Week 8

The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Mean Change in Pruritus Scores	-3 units on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: Baseline to Week 16

The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Mean Change in Pruritus Scores	-3 units on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: Baseline to Week 8

The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Mean Change in BSA	-1 percentage of body surface area affected Standard Deviation 2

SECONDARY outcome

Timeframe: Week 16

The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Mean Change in BSA	-2 percentage of body surface area affected Standard Deviation 3

SECONDARY outcome

Timeframe: Baseline to Week 8

The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Percent Change in BSA	-19 percent change Standard Deviation 28

SECONDARY outcome

Timeframe: Baseline to Week 16

The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Percent Change in BSA	-36 percent change Standard Deviation 49

SECONDARY outcome

Timeframe: Week 8

The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Proportion of Patients Who Achieve PASI 50	3 Participants

SECONDARY outcome

Timeframe: Week 16

The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Proportion of Patients Who Achieve PASI 50	8 Participants

SECONDARY outcome

Timeframe: Week 8

The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Proportion of Patients Who Achieve PASI 75	0 Participants

SECONDARY outcome

Timeframe: Week 16

The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
Proportion of Patients Who Achieve PASI 75	6 Participants

SECONDARY outcome

Timeframe: Week 8

The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
% of Patients Achieving Clear or Almost Clear on the PtGA	10 Participants

SECONDARY outcome

Timeframe: Week 16

The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)

Outcome measures

Measure	Apremilast n=20 Participants Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
% of Patients Achieving Clear or Almost Clear on the PtGA	9 Participants

Adverse Events

Apremilast

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Apremilast n=20 participants at risk Apremilast, 30 mg. tablets, two times a day for 16 weeks Apremilast
General disorders headache	25.0% 5/20 • Number of events 5 • 20 weeks
Gastrointestinal disorders diarrhea	30.0% 6/20 • Number of events 6 • 20 weeks
General disorders irritability	5.0% 1/20 • Number of events 1 • 20 weeks
Gastrointestinal disorders upset stomach, unspecified	15.0% 3/20 • Number of events 3 • 20 weeks
Gastrointestinal disorders nausea	30.0% 6/20 • Number of events 6 • 20 weeks
General disorders leg cramps	5.0% 1/20 • Number of events 1 • 20 weeks
Infections and infestations upper respiratory infection	5.0% 1/20 • Number of events 1 • 20 weeks
Infections and infestations otitis externa	5.0% 1/20 • Number of events 1 • 20 weeks
Gastrointestinal disorders abdominal cramping	15.0% 3/20 • Number of events 3 • 20 weeks
Gastrointestinal disorders viral gastroenteritis	5.0% 1/20 • Number of events 1 • 20 weeks
Skin and subcutaneous tissue disorders cyst left inner thigh	5.0% 1/20 • Number of events 1 • 20 weeks
Skin and subcutaneous tissue disorders abscess right hand	5.0% 1/20 • Number of events 1 • 20 weeks
Gastrointestinal disorders heartburn	10.0% 2/20 • Number of events 2 • 20 weeks
General disorders right flank pain	5.0% 1/20 • Number of events 1 • 20 weeks

Additional Information

M. McAllister

Skin Sciences, PLLC

Phone: 5024519000

Email: mmdermresearch@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place