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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:December 29, 2016
End Date:April 25, 2018

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

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)

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
We found this trial at
1
site
Louisville, Kentucky 40217
Phone: 502-451-9000
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Louisville, KY
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