PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF APREMILAST IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS OF THE SCALP

What we are studying

The purpose of this research study is to see if Apremilast works by blocking an enzyme in the body called phosphodiesterase 4 (PDE4) that is usually elevated in medical conditions involving inflammation, such as inflammation of the skin in psoriasis. Apremilast is in the form of tablets and is taken by mouth. Apremilast has been approved in approximately 40 countries worldwide, including Canada and the U.S. for the treatment of moderate to severe plaque psoriasis. The use of apremilast in this study is considered investigational as there is no current data in the Clinical Studies section of the US label regarding effectiveness and safety of apremilast treatment for scalp psoriasis lesions.The study will test apremilast and compare its effects with placebo in the treatment of moderate to severe scalp and body psoriasis. A placebo does not have any active medication but looks exactly like the study drug (apremilast) tablet. This study will test how well your body tolerates apremilast, and how successfully apremilast treats your psoriasis.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • American Indian or Alaska Native
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Moderate to severe plaque psoriasis of scalp (involving 20% of the scalp) that has had an inadequate response or intolerance to at least 1 topical therapy AND moderate to severe plaque psoriasis of the remaining body surface (involving 10% of the body)
  • Females of childbearing potential must have negative pregnancy test and those who engage in activity in which conception is possible must use contraception while on study medication and for at least 28 days after taking the last dose
  • No history of active TB; incompletely treated TB; HIV or history of substance abuse in last 6 months
  • No prior history of suicide attempt or hospitalization for a major psychiatric illness in last 3 years
  • No prior treatment with Apremilast

What is involved

  • Screening involves blood work; ECG; CXR; physical exam; and assessments of scalp/body psoriasis
  • 16 weeks of treatment with placebo OR Apremilast followed by 16 weeks of treatment with open label Apremilast.

Compensation

You will be paid $550 if you complete all the scheduled study visits. If you withdraw for any reason from the study before completion you will be paid $50 for each complete study visit.

Contact Information

Study Coordinator
Pat Wagoner
Email
pwagoner@wakeheal;th.edu
Phone
336-716-3775
Principal Investigator
Steven R Feldman

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.