Phase 4 N=20 Treatment

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

Plaque Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT03000309 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2019

Primary outcome: Primary: Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16 — -9 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Apremilast (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Derm Research, PLLC
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16	-9	—
PRIMARY Percent Change in Product of BSA and sPGA	-29	—
SECONDARY Percent Change in Product of BSA and sPGA	-29	—
SECONDARY Mean Change in DLQI	-7	—
SECONDARY Mean Change in DLQI	-7	—
SECONDARY Mean Change in Pruritus Scores	-3	—
SECONDARY Mean Change in Pruritus Scores	-3	—
SECONDARY Mean Change in BSA	-2	—
SECONDARY Mean Change in BSA	-2	—
SECONDARY Percent Change in BSA	-36	—
SECONDARY Percent Change in BSA	-36	—
SECONDARY Proportion of Patients Who Achieve PASI 50	8	—
SECONDARY Proportion of Patients Who Achieve PASI 50	8	—
SECONDARY Proportion of Patients Who Achieve PASI 75	6	—
SECONDARY Proportion of Patients Who Achieve PASI 75	6	—
SECONDARY % of Patients Achieving Clear or Almost Clear on the PtGA	9	—
SECONDARY % of Patients Achieving Clear or Almost Clear on the PtGA	9	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03000309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.