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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Lodz Poland
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Dermedic Jacek Zdybski Ostrowiec Swietokrzyski Poland
Sanatorium profesora Arenbergera Prague Czechia
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Gyncentrum Sp. z o.o. Katowice Poland
Veselibas Centrs 4 SIA Riga Latvia
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c. Osielsko Poland
Royalderm Agnieszka Nawrocka Warsaw Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak Lodz Poland

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Praglandia s.r.o. Prague Czechia
Medical Center Hera EOOD Sofia Bulgaria
Rigas 1. slimnica SIA Riga Latvia
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Pratia Pardubice a.s. Pardubice Czechia
Centre Hospitalier Le Mans Le Mans France
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Adoria SIA Riga Latvia
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Diagnostics And Consultancy Center Sveti Georgi EOOD Haskovo Bulgaria
Pratia Brno s.r.o. Brno-Stred Czechia
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Ambulatorium Sp. z o.o. Elblag Poland
Asclepius Medical Center OOD Dupnitsa Bulgaria
Du Docteur Ruer S.E.L.A.R.L. Martigues France
Etg Neuroscience Sp. z o.o. Warsaw Poland
UNIMED Medical Center EOOD Plovdiv Bulgaria
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
Clintrial s.r.o. Prague Czechia
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Klinika Ambroziak Sp. z o.o. Warsaw Poland
MICS Centrum Medyczne Warszawa, Chłodna Warsaw Poland
Dnlmuumazt Aal Cyacynatkd Cnodgg Xinjomgggpwx Edyk Sofia Bulgaria
Jyintjs Slr Riga Latvia
Vnhqxqdx ug efxjvxip Swm Riga Latvia
Dimmfoma spflcg Povel Czechia
Swbsvkldje Sjb Kuldiga Latvia
Mfqseew Cztdiu Fzwzulwooz Expv Sofia Bulgaria
Cpekrui Bvgdo Kyoioggppfl Pncjnpip Sko z orvk Gdansk Poland
Mdscszgq Mtbljfv Avdnymi Pleven Bulgaria
Dddlyuubfp Sgn z oaqq Wroclaw Poland
Lrwkxze Sqaklbkvljnhkda Gsiglau Dqwqcjhvtyendef Lublin Poland
Iypgfvah dw Csfixkavztgc Hnwiwaokuim Ucsdioobmqxfw du Skepu Eejdzcm (uglkhsb Saint Priest En Jarez France
Mrkmdhw Cweylx Mfrerultgr Pkbmkj Odj Pleven Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
05.09.2025
Czechia Czechia
Not recruiting
05.09.2025
France France
Not recruiting
05.09.2025
Latvia Latvia
Not recruiting
05.09.2025
Poland Poland
Not recruiting
05.09.2025

Trial locations

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.

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 ID:
2024-512497-10-00
Protocol code:
TAK-279-PsO-3004
Trial Phase:
Therapeutic confirmatory (Phase III)

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