Back to resultsUse of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Apremilast
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Subjects must be in general good health as judged by investigator
- Female of childbearing potential (FCBP) must have a negative pregnancy test at screening and Baseline.
- FCBP must use an approved method of contraception as outlined in the protocol.
- Male subjects who engage in activity in which conception is possible must use barrier contraception as defined in the protocol.
- 18 years of age or older
- Understand and voluntarily sign the Informed Consent
- Able to adhere to study visit schedule
- Moderate plaque type psoriasis as define by a a PGA of 3
- BSA 0f 5-10% or a DLQI score of 7 or more
- History of uncontrolled plaque psoriasis after either stable dose of high potency topical steroids for 2 weeks or mid-potency steroids for 4 weeks within the last 6 months
Exclusion Criteria:
- Any clinically significant disease as determined by the investigator or major disease that is currently uncontrolled
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk
- Prior history of suicide attempt at any time in the subject's lifetime prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years
- Pregnant or breastfeeding, FCBP who are not willing to use acceptable birth control methods.
- Active substance abuse or a history of substance abuse within 6 months prior to screening.
- Malignancy or history of malignancy except fo treated (cured) basal cell or or squamous cell in situ skin carcinomas, treated (cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
- Has not completed the prescribed washout for restricted treatments
- Known or suspected allergy to investigational product
- Other types of psoriasis
- Prior history of depression
- Prior use of apremilast
Sites / Locations
- DermResearch, PLLC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Apremilast
Arm Description
Apremilast, 30 mg. tablets, two times a day for 16 weeks
Outcomes
Primary Outcome Measures
Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From 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. 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.
Percent Change in Product of BSA and sPGA
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.
Secondary Outcome Measures
Percent Change in Product of BSA and sPGA
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.)
Mean Change in DLQI
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.
Mean Change in DLQI
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.
Mean Change in Pruritus Scores
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)
Mean Change in Pruritus Scores
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)
Mean Change in BSA
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
Mean Change in BSA
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
Percent Change in BSA
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
Percent Change in BSA
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
Proportion of Patients Who Achieve PASI 50
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.)
Proportion of Patients Who Achieve PASI 50
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.)
Proportion of Patients Who Achieve PASI 75
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.)
Proportion of Patients Who Achieve PASI 75
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.)
% of Patients Achieving Clear or Almost Clear on the PtGA
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.)
% of Patients Achieving Clear or Almost Clear on the PtGA
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.)
Full Information
NCT ID
NCT03000309
First Posted
December 15, 2016
Last Updated
March 26, 2019
Sponsor
Derm Research, PLLC
Collaborators
Celgene
1. Study Identification
Unique Protocol Identification Number
NCT03000309
Brief Title
Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy
Official Title
Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Derm Research, PLLC
Collaborators
Celgene
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sixteen week open label study of apremilast in combination with topical steroids with a four week safety follow up visit.
Detailed Description
This is an open label, 16 week study of apremilast in combination with topical corticosteroids (TCS). Twenty qualified subjects will be enrolled. Visits will consist of Baseline, 8 week, 16 week and a 20 week safety follow up after 4 weeks off treatment. Subjects will dose with apremilast as per label. Topical corticosteroids (TCS) will be used for up to Week 4 as per label and then will be used on an as needed basis until Week 16. Assessments will include Static Physicians Global Assessment (sPGA), Psoriasis Area Severity Index (PASI), Psoriatic Body Surface Area (BSA), Dermatology Life Quality Index (DLQI),Assessment of Pruritus, Patient Satisfaction questionnaire. and Patient Global Assessment (PtGA)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apremilast
Arm Type
Other
Arm Description
Apremilast, 30 mg. tablets, two times a day for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
Otezla
Primary Outcome Measure Information:
Title
Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16
Description
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.
Time Frame
Week 16
Title
Percent Change in Product of BSA and sPGA
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percent Change in Product of BSA and sPGA
Description
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.)
Time Frame
Week 8
Title
Mean Change in DLQI
Description
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.
Time Frame
Week 8
Title
Mean Change in DLQI
Description
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.
Time Frame
Week 16
Title
Mean Change in Pruritus Scores
Description
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)
Time Frame
Baseline to Week 8
Title
Mean Change in Pruritus Scores
Description
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)
Time Frame
Baseline to Week 16
Title
Mean Change in BSA
Description
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
Time Frame
Baseline to Week 8
Title
Mean Change in BSA
Description
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
Time Frame
Week 16
Title
Percent Change in BSA
Description
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
Time Frame
Baseline to Week 8
Title
Percent Change in BSA
Description
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
Time Frame
Baseline to Week 16
Title
Proportion of Patients Who Achieve PASI 50
Description
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.)
Time Frame
Week 8
Title
Proportion of Patients Who Achieve PASI 50
Description
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.)
Time Frame
Week 16
Title
Proportion of Patients Who Achieve PASI 75
Description
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.)
Time Frame
Week 8
Title
Proportion of Patients Who Achieve PASI 75
Description
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.)
Time Frame
Week 16
Title
% of Patients Achieving Clear or Almost Clear on the PtGA
Description
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.)
Time Frame
Week 8
Title
% of Patients Achieving Clear or Almost Clear on the PtGA
Description
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.)
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be in general good health as judged by investigator
Female of childbearing potential (FCBP) must have a negative pregnancy test at screening and Baseline.
FCBP must use an approved method of contraception as outlined in the protocol.
Male subjects who engage in activity in which conception is possible must use barrier contraception as defined in the protocol.
18 years of age or older
Understand and voluntarily sign the Informed Consent
Able to adhere to study visit schedule
Moderate plaque type psoriasis as define by a a PGA of 3
BSA 0f 5-10% or a DLQI score of 7 or more
History of uncontrolled plaque psoriasis after either stable dose of high potency topical steroids for 2 weeks or mid-potency steroids for 4 weeks within the last 6 months
Exclusion Criteria:
Any clinically significant disease as determined by the investigator or major disease that is currently uncontrolled
Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk
Prior history of suicide attempt at any time in the subject's lifetime prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years
Pregnant or breastfeeding, FCBP who are not willing to use acceptable birth control methods.
Active substance abuse or a history of substance abuse within 6 months prior to screening.
Malignancy or history of malignancy except fo treated (cured) basal cell or or squamous cell in situ skin carcinomas, treated (cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
Has not completed the prescribed washout for restricted treatments
Known or suspected allergy to investigational product
Other types of psoriasis
Prior history of depression
Prior use of apremilast
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon H. Kircik, M.D.
Organizational Affiliation
DermResearch PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy
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