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

Derm Research

Status and phase

Completed

Phase 4

Conditions

Plaque Psoriasis

Treatments

Drug: Apremilast

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03000309

APR-2015

Details and patient eligibility

About

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

Full 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)

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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