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

Sixteen week open label study of apremilast in combination with topical steroids with a four week safety follow up visit.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Apremilast

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)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Apremilast; Apremilast, 30 mg. tablets, two times a day for 16 weeks	Drug: Apremilast; Other Names: Otezla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 16
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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	Week 8
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.	Week 8
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.	Week 16
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)	Baseline to Week 8
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)	Baseline to Week 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	Baseline to Week 8
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	Week 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	Baseline to Week 8
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	Baseline to Week 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.)	Week 8
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.)	Week 16
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.)	Week 8
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.)	Week 16
% 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.)	Week 8
% 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.)	Week 16

Collaborators and Investigators

• Sponsor: Derm Research, PLLC
• Collaborators: Celgene
• Investigators: Principal Investigator: Leon H. Kircik, M.D., DermResearch PLLC

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 25, 2018

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: APR-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No