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Comparison of zasocitinib and deucravacitinib in adults with moderate to severe plaque psoriasis

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What is this trial about?

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

This clinical trial focuses on comparing two medications in people with moderate-to-severe plaque psoriasis, a chronic skin condition that causes red, scaly patches on the skin that have been present for at least 6 months. The study will evaluate two oral medications: zasocitinib (also known as TAK-279) and deucravacitinib (SOTYKTU), which are taken once daily. Some participants will receive placebo instead of active medication.

The purpose of this research is to determine if zasocitinib works better than deucravacitinib in treating moderate-to-severe plaque psoriasis. The study will specifically look at how well these medications clear the skin condition by measuring improvements in the affected areas of skin and the severity of psoriasis symptoms.

During the 16-week study period, participants will take their assigned medication by mouth once each day. The effectiveness of the treatment will be evaluated by examining changes in the skin's appearance and measuring the reduction in psoriasis symptoms. Throughout the study, doctors will monitor participants' health and safety through regular check-ups, including physical examinations and laboratory tests.

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 assessment

    Your eligibility for the trial will be assessed based on having moderate-to-severe plaque psoriasis for at least 6 months

    The doctor will check if your psoriasis covers at least 10% of your body surface and meets specific severity scores

    You must be 18 years or older to participate

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either zasocitinib or deucravacitinib

    Both medications come as film-coated tablets that you will take by mouth once daily

    Neither you nor your doctor will know which medication you are receiving during the trial

  3. Step 3

    Treatment period

    The treatment will continue for 16 weeks

    You will take your assigned medication once daily by mouth

    Your psoriasis symptoms will be monitored at weeks 4, 8, 12, and 16

    Regular checks of your vital signs, laboratory tests, and heart measurements will be performed

  4. Step 4

    Monitoring visits

    Your progress will be tracked through regular assessments of your skin condition

    The doctor will measure the improvement in your psoriasis using standardized scoring systems

    Any side effects or health changes will be recorded during the study

  5. Step 5

    Final assessment

    At week 16, a final evaluation of your psoriasis improvement will be conducted

    The effectiveness of the treatment will be measured by checking how clear your skin has become

    A complete safety assessment will be performed to check for any health changes

Who can join the trial?

10 criteria

  • Must be 18 years of age or older
  • Must have been diagnosed with plaque psoriasis for at least 6 months before screening
  • Must have stable plaque psoriasis (no major changes in symptoms) for at least 6 months before screening
  • Must have moderate to severe plaque psoriasis with: - A PASI score of 12 or higher (a measure of psoriasis severity) - An sPGA score of 3 or higher (another measure of psoriasis severity) - Psoriasis covering at least 10% of body surface area
  • Must be suitable for receiving phototherapy (light therapy) or systemic therapy (medicine that works throughout the body)
  • Must be willing and able to understand and follow all study procedures, including using digital tools and applications
  • Must provide written informed consent before starting any study procedures
  • For participants who can become pregnant: - Must be surgically sterile, or - Must have confirmed post-menopausal status, or - Must use highly effective birth control throughout the study and for 10 days after the last dose if sexually active
  • For participants aged 65 or older, the doctor must determine that the benefits outweigh any risks
  • For current or former long-term tobacco users (20 or more pack-years), the doctor must determine that the benefits outweigh any risks

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • History of serious allergic reactions to similar medications
  • Active or chronic infections, including tuberculosis (a bacterial infection primarily affecting the lungs)
  • Significant heart problems or recent heart-related events
  • Severe kidney or liver disease
  • Current cancer or history of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Active substance abuse or alcohol dependency
  • Participation in other clinical trials within the past 30 days
  • Use of other systemic psoriasis treatments (medications that work throughout the entire body) within specified washout periods
  • Severe or uncontrolled high blood pressure
  • Unstable mental health conditions
  • History of autoimmune conditions (diseases where the immune system attacks healthy cells) other than psoriasis
  • Major surgery planned during the study period
  • Significant abnormal laboratory test results
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Investigated drugs

  • Zasocitinib

    (also known as TAK-279) is an oral medication taken once daily that works by modifying the immune system response. It is being studied as a treatment for moderate-to-severe plaque psoriasis, a condition that causes red, scaly patches on the skin.

  • Deucravacitinib

    is an oral medication taken once daily that helps treat plaque psoriasis by targeting specific proteins in the immune system that are responsible for inflammation. It is already approved for treating moderate-to-severe plaque psoriasis in some countries and serves as a comparison treatment in this study.

What is already known about the treatment

  • Zasocitinib (TAK-279)

    An oral medication administered once daily that belongs to the class of novel immunomodulatory drugs currently being investigated in clinical trials for the treatment of moderate to severe plaque psoriasis. The drug works by targeting specific cellular signaling pathways involved in inflammation and immune response, helping to reduce the excessive skin cell growth characteristic of psoriasis. This investigational medicine is being evaluated for its efficacy and safety compared to existing treatments, with promising potential in managing autoimmune skin conditions.

  • Deucravacitinib

    An oral medication taken once daily that functions as a selective tyrosine kinase 2 (TYK2) inhibitor, approved for treating moderate to severe plaque psoriasis. The drug works by blocking specific inflammatory signaling pathways that contribute to psoriasis development, helping to reduce skin inflammation and normalize skin cell growth. This medication represents a targeted approach to treating psoriasis with a unique mechanism of action that differentiates it from traditional systemic treatments.

Investigated diseases

Plaque Psoriasis - A chronic skin condition characterized by raised, red patches covered with silvery-white scales that typically appear on the elbows, knees, scalp, and lower back. The condition occurs when skin cells multiply much faster than normal, causing cells to build up on the skin's surface. These patches, known as plaques, can be itchy and sometimes painful. The severity can range from mild to severe, with moderate to severe cases covering larger areas of the body. The condition tends to go through cycles, flaring for a few weeks or months and then subsiding or going into remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512497-10-00Protocol codeTAK-279-PsO-3004Estimated enrolment622 patientsSponsorTakeda Development Center Americas Inc.

sourced from the EU Clinical Trials Register and site verification

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