Clinical trial NCT03000309: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2016-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16
timeFrame: Week 16
measure: Percent Change in Product of BSA and sPGA
timeFrame: Week 16
Secondary outcomes:
measure: Percent Change in Product of BSA and sPGA
timeFrame: Week 8
measure: Mean Change in DLQI
timeFrame: Week 8
measure: Mean Change in DLQI
timeFrame: Week 16
measure: Mean Change in Pruritus Scores
timeFrame: Baseline to Week 8
measure: Mean Change in Pruritus Scores
timeFrame: Baseline to Week 16
measure: Mean Change in BSA
timeFrame: Baseline to Week 8
measure: Mean Change in BSA
timeFrame: Week 16
measure: Percent Change in BSA
timeFrame: Baseline to Week 8
measure: Percent Change in BSA
timeFrame: Baseline to Week 16
measure: Proportion of Patients Who Achieve PASI 50
timeFrame: Week 8
measure: Proportion of Patients Who Achieve PASI 50
timeFrame: Week 16
measure: Proportion of Patients Who Achieve PASI 75
timeFrame: Week 8
measure: Proportion of Patients Who Achieve PASI 75
timeFrame: Week 16
measure: % of Patients Achieving Clear or Almost Clear on the PtGA
timeFrame: Week 8
measure: % of Patients Achieving Clear or Almost Clear on the PtGA
timeFrame: Week 16
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
affiliation: DermResearch PLLC
name: Leon H. Kircik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: