Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy (NCT03000309) | Clinical Trial Compass
CompletedPhase 4
Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy
United States20 participantsStarted 2016-12-29
Plain-language summary
Sixteen week open label study of apremilast in combination with topical steroids with a four week safety follow up visit.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (…
What they're measuring
1
Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16