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

NCT ID: NCT03000309

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-29
• Study Completion Date: 2018-04-25

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)

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apremilast

Apremilast, 30 mg. tablets, two times a day for 16 weeks

Group Type: OTHER

Apremilast

Intervention Type: DRUG

Interventions

Apremilast

Intervention Type: DRUG

Other Intervention Names

Otezla

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

Derm Research, PLLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leon H. Kircik, M.D.

Role: PRINCIPAL_INVESTIGATOR

DermResearch PLLC

Locations

DermResearch, PLLC

Louisville, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

APR-2015

Identifier Type: -

Identifier Source: org_study_id