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

NCT03000309 | Completed Phase 4 Results

• 1 other identifier: APR-2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16

  The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) of disease severity is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.

  Week 16

• Percent Change in Product of BSA and sPGA

  The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0(no disease) and 500 (most severe disease.) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.

  Week 16

Secondary Outcomes (15)

• Percent Change in Product of BSA and sPGA

  Week 8

• Mean Change in DLQI

  Week 8

• Mean Change in DLQI

  Week 16

• Mean Change in Pruritus Scores

  Baseline to Week 8

• Mean Change in Pruritus Scores

  Baseline to Week 16

Study Arms (1)

Apremilast

OTHER

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

Drug: Apremilast

Interventions

Apremilast DRUG

Also known as: Otezla

Apremilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Derm Research, PLLC: lead
• Celgene: collaborator

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Interventions

apremilast

Results Point of Contact

• Title: M. McAllister
• Organization: Skin Sciences, PLLC

mmdermresearch@yahoo.com

5024519000

Study Officials

• Leon H. Kircik, M.D.

  DermResearch PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 22, 2016
• Study Start: December 29, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 25, 2018
• Last Updated: March 28, 2019
• Results First Posted: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)