Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of TAK-279 and apremilast for adults with moderate to severe plaque psoriasis

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on patients with moderate-to-severe plaque psoriasis, a chronic skin condition causing red, scaly patches on the skin that has been present for at least 6 months. The study will evaluate a new medication called TAK-279 (zasocitinib) compared to Otezla (apremilast) and placebo. All medications will be given as tablets that are taken by mouth once daily.

The main purpose is to determine how well TAK-279 works in treating plaque psoriasis over a 16-week period. The study will measure improvements in skin appearance and the extent of psoriasis coverage on the body. The total duration of treatment will be 52 weeks.

During the study, participants will be randomly assigned to receive either TAK-279, Otezla, or placebo tablets. The effectiveness of the treatment will be assessed by examining changes in the appearance and severity of psoriasis symptoms, including improvements in skin clearance and reduction in the affected areas. The study will also evaluate how the medications affect psoriasis on specific body areas such as the scalp, nails, hands, and feet.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and medication start

    Your participation begins with an assessment of your plaque psoriasis condition using specific measurement tools to evaluate the severity of symptoms.

    You will be randomly assigned to receive one of the following treatments: TAK-279 tablets, Otezla (apremilast) tablets, or a placebo tablet, all taken by mouth once daily.

    If you receive Otezla, your treatment will start with a gradual dose increase: starting with 10 mg, then 20 mg, and finally reaching 30 mg tablets.

  2. Step 2

    First treatment period - Week 1 to Week 16

    You will take your assigned medication once daily by mouth for 16 weeks.

    Regular evaluations will measure your skin condition using two main scales:

    - The static Physician's Global Assessment (sPGA), which measures the overall appearance of your psoriasis

    - The Psoriasis Area and Severity Index (PASI), which measures the extent and severity of psoriasis

  3. Step 3

    Extended treatment period - Week 16 to Week 24

    Treatment continues for an additional 8 weeks.

    During this period, additional assessments will track changes in your:

    - Scalp psoriasis

    - Nail psoriasis

    - Affected body surface area

    - Psoriasis on hands and feet

  4. Step 4

    Final evaluation

    At the end of the 24-week period, a final assessment will measure the overall effectiveness of the treatment.

    The evaluation will include all previously measured aspects of your psoriasis condition.

Who can join the trial?

11 criteria

  • You must be 18 years or older at the time you agree to participate
  • You must have been diagnosed with plaque psoriasis for at least 6 months before screening
  • Your psoriasis must be stable (no major changes or flare-ups) for at least 6 months before screening
  • You must have moderate to severe plaque psoriasis as measured by specific assessment tools (PASI score of 12 or higher and sPGA score of 3 or higher)
  • Your psoriasis must cover at least 10% of your body surface area
  • You must be suitable for receiving phototherapy (light treatment) or systemic therapy (medicine that works throughout the body)
  • You must be willing and able to understand and follow all study procedures, including using digital tools and applications
  • You must provide written informed consent before any study procedures begin
  • If you can 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 sexually active
    • 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

Who cannot join the trial?

14 criteria

  • History of serious infections or current active infections, including tuberculosis (TB - a bacterial infection affecting the lungs)
  • Current diagnosis of cancer or history of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Significant heart problems including heart failure (when heart cannot pump blood effectively)
  • Active hepatitis B or C infection (viral infections affecting the liver)
  • Presence of other skin conditions that could interfere with evaluating psoriasis
  • Use of other psoriasis treatments within specified time periods before study start
  • Known allergic reactions to similar medications
  • Pregnant or breastfeeding women
  • Severe kidney or liver problems
  • Recent live vaccines (within 30 days before study start)
  • History of substance abuse within the past year
  • Any condition that could make it unsafe to participate in the study
  • Participation in another clinical trial within past 30 days
  • Major surgery planned during the study period
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

TAK-279 is an oral medication (taken by mouth) that is being studied for treating moderate to severe plaque psoriasis. It is taken once daily and represents a new potential treatment option for patients with this skin condition. This medication is still being investigated to understand how well it works and how safe it is for patients with psoriasis. Note: The trial also includes placebo and an active comparator, but their specific details are not provided in the source 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. This novel therapeutic agent belongs to the class of targeted immunomodulators, though its specific molecular mechanism of action is not yet publicly disclosed in medical literature. The medication is being evaluated for its efficacy, safety, and tolerability compared to both placebo and active control treatments, representing a potential new oral treatment option for patients with plaque psoriasis.

Investigated diseases

Plaque Psoriasis - A chronic inflammatory skin condition characterized by raised, red patches covered with silvery-white scales. These patches typically appear on the elbows, knees, scalp, and lower back, but can affect any area of the body. The condition develops when skin cells multiply much faster than normal, causing the cells to build up on the surface. The patches (plaques) can be itchy, painful, and may crack or bleed. 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, with periods of flare-ups alternating with periods of remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505841-22-00Protocol codeTAK-279-3001Estimated enrolment600 patientsSponsorTakeda Development Center Americas Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).