TAK-279-3002 (Moderate-to-Severe Plaque Psoriasis) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called TAK-279 (the study drug) can help in controlling moderate-to-severe plaque psoriasis by evaluating how your body responds to and processes the study drug compared to apremilast and placebo.

What is the Condition Being Studied?

Moderate-to-Severe Plaque Psoriasis

Who Can Participate in the Study?

Adults ages 18+ who:

  • Were diagnosed with plaque psoriasis at least 6 months ago
  • Have plaque lesions that cover at least 10% of the body
  • Have not had any significant changes to their health for the past 6 months
  • For more information about who can join this study, please contact the study team at erin.campo@duke.edu.

    Age Group
    Adults

    What is Involved?

    If you decide to join this study, your participation will be broken up into 3 periods:

    • Screening period
    • Study drug period
    • Follow-up period

    During the screening period, you will visit our clinic for a physical exam and to have some tests done to find out if you are eligible. If you meet the study’s criteria, you will proceed to the study drug period. During this period, you will get a random assignment (fair, equal chance) to either:

    • Take the study drug; OR
    • Take apremilast; OR
    • Take a placebo

    You will have 18 visits to our clinic during the study drug period.

    Fasting blood samples will be collected on days when your cholesterol is checked. Fasting means no food or beverages should be taken for at least 8 hours before your blood is collected. The study team will let you know which days these visits will be.

    When you finish taking the study drug, you will begin the follow-up period. During this period there is one visit to our clinic and your study doctor will continue to assess your health.

    Study Details

    Full Title
    A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator- Controlled Study With a Randomized Withdrawal and Retreatment Period to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
    Principal Investigator
    Dermatologist
    Protocol Number
    IRB: PRO00114003
    Phase
    Phase III
    Enrollment Status
    Open for Enrollment