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Study of zasocitinib (TAK-279) and apremilast compared to placebo in adults with moderate to severe plaque psoriasis

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study focuses on treating moderate-to-severe plaque psoriasis, a chronic skin condition that causes raised, red, scaly patches on the skin. The study will evaluate a new medication called TAK-279 (zasocitinib) compared to apremilast (Otezla) and placebo. The main purpose is to determine how well TAK-279 works when taken as a daily oral tablet for 16 weeks in people with this type of psoriasis.

The study involves taking either TAK-279, apremilast, or placebo in the form of tablets that are swallowed. During the study, doctors will monitor how well the medications work by examining changes in the skin's appearance and the extent of psoriasis coverage on the body. They will look at improvements in skin clearance and reduction in psoriasis symptoms.

The research will include periods where some participants may switch between different treatments to better understand how the medication works over time. The study will track various aspects of psoriasis, including how it affects the scalp, nails, hands, and feet. Participants will be monitored for approximately 60 weeks to evaluate both the effectiveness and safety of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    You will begin a 16-week treatment period receiving either TAK-279 tablets, apremilast tablets (Otezla), or placebo tablets once daily

    The tablets should be taken by mouth

    During this period, your skin condition will be regularly evaluated using special assessment tools that measure the extent and severity of psoriasis

  2. Step 2

    Week 16 evaluation

    Your response to treatment will be assessed at week 16

    The assessment will focus on how clear your skin has become and how much improvement you have experienced

    The evaluation includes checking the percentage of improvement in your psoriasis symptoms

  3. Step 3

    Extended treatment period

    Treatment continues until week 24

    Additional assessments will be performed to evaluate ongoing response to treatment

    Specific attention will be given to psoriasis on your scalp, nails, hands, and feet

  4. Step 4

    Randomized withdrawal period

    At week 40, if you have achieved at least 75% improvement in your symptoms, you will enter a withdrawal period

    During this time, some participants will continue treatment while others will stop

    This period continues until week 60

  5. Step 5

    Final evaluation

    The study concludes with final assessments of your psoriasis symptoms

    The total duration of participation may last until mid-2026

    Throughout the study, regular evaluations will track any changes in your skin condition

Who can join the trial?

13 criteria

  • You must be 18 years or older at the time of giving consent
  • You must have been diagnosed with plaque psoriasis for at least 6 months before screening
  • Your psoriasis must be stable (no significant changes) for at least 6 months before screening
  • You must have moderate to severe plaque psoriasis as determined by specific measurement scores (PASI score ≥12 and sPGA score ≥3)
  • Your psoriasis must cover at least 10% of your body surface area
  • You must be suitable for receiving phototherapy (light therapy) or systemic therapy (medication that affects your entire body)
  • You must be willing and able to follow all study procedures, including using digital tools and applications
  • You must provide written informed consent before starting any study procedures
  • If you are able to become pregnant, you must either:
    • Be post-menopausal (confirmed by laboratory tests), or
    • Use highly effective birth control methods during the study and for 10 days after the last dose
    • If you use oral contraceptives, you must use an additional form of birth control (preferably a male condom) during the study and for 10 days after the last dose
    • If you are 65 years or older, your doctor must determine that the benefits of participating outweigh the risks
    • If you currently smoke or have a long history of smoking (20 pack-years or more), your doctor must determine that the benefits of participating outweigh the risks

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Currently pregnant or breastfeeding women
  • History of serious allergic reactions to medications
  • Active or chronic infections, including tuberculosis (a bacterial infection primarily affecting the lungs)
  • Significant heart, liver, or kidney disease
  • Current diagnosis of cancer or history of cancer in the past 5 years
  • Use of other systemic medications (medications that affect the entire body) for psoriasis within the past 4 weeks
  • Use of topical treatments (creams, ointments applied to skin) for psoriasis within the past 2 weeks
  • Participation in other clinical trials within the past 30 days
  • History of substance abuse within the past year
  • Unstable mental health conditions
  • Severe infections requiring hospitalization within the past 3 months
  • Uncontrolled high blood pressure
  • Poorly controlled diabetes
  • Major surgery planned during the study period
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Investigated drugs

TAK-279 is an experimental oral medication taken once daily that is being studied for treating moderate-to-severe plaque psoriasis. This is a new drug that is still being tested to see how well it works in reducing psoriasis symptoms. Unlike many psoriasis treatments that are applied to the skin or given as injections, this medication is taken by mouth. The trial includes a placebo for comparison, which is a tablet that looks identical to TAK-279 but contains no active medication. Note: The study is described as having an active comparator, but the specific medication used as the active comparator is not mentioned in the provided data.

What is already known about the treatment

TAK-279 – An investigational oral medication administered once daily that is currently being studied in Phase 3 clinical trials for the treatment of moderate to severe plaque psoriasis. It belongs to a new generation of targeted therapies, though its specific pharmacological classification is not publicly disclosed in the current trial data. The medication is being evaluated for its efficacy compared to placebo in patients with plaque psoriasis, with the trial including a randomized withdrawal and retreatment period to assess long-term effectiveness. While the exact molecular mechanism of action is not specified in the source data, the medication is being developed by Takeda Pharmaceuticals as a potential new treatment option for patients with moderate to severe psoriasis symptoms.

Investigated diseases

Plaque Psoriasis - A chronic autoimmune skin condition that causes cells to build up rapidly on the surface of the skin. These excess cells form thick, silvery scales and itchy, dry, red patches that can be painful. The patches most commonly appear on the scalp, knees, elbows, and lower back, though they can occur anywhere on the body. The condition typically goes through cycles, flaring for a few weeks or months, then subsiding for a time. Plaque psoriasis is characterized by raised, inflamed patches of skin covered by silvery white scales, which can crack and bleed. The condition can vary in severity, from a few spots of dandruff-like scaling to major eruptions that cover large areas of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505842-24-00Protocol codeTAK-279-3002Estimated enrolment1 117 patientsSponsorTakeda Development Center Americas Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).