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A study to evaluate the effectiveness and safety of zasocitinib in children and adolescents with moderate-to-severe plaque psoriasis

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What is this study about?

This study is being conducted to evaluate the effectiveness and safety of zasocitinib in children and adolescents with Plaque Psoriasis, a chronic skin condition characterized by red, itchy, and scaly patches. Participants will receive either zasocitinib, which is an oral medication taken as a film-coated tablet, or a placebo. The study is divided into different groups to look at how the drug works in older children and how the body processes the medicine, known as pharmacokinetics, in younger children.

In the first part of the study, participants are assigned to receive either the active medication or a placebo for 16 weeks. The research aims to see how much the skin improves and if the medication is well-tolerated. Researchers will also look at changes in skin coverage and how much the itching affects daily life. After the initial period, some participants may move into an open-label phase, where everyone receives the active medication.

Who Can Join the Study?

  • The person participating must have had chronic plaque psoriasis, which is a long-term skin condition that causes thick, red, scaly patches, for at least 6 months.
  • The skin condition must be stable, meaning there have been no major sudden worsening or significant changes in how the skin patches look for at least 6 months.
  • The condition must be moderate-to-severe, which is measured by specific medical scales: a PASI score (a tool used to measure the severity of psoriasis) of 12 or higher and an sPGA score (a scale used by doctors to grade skin disease) of 3 or higher.
  • The psoriasis must cover at least 10% of the total BSA, which stands for Body Surface Area, or the total amount of skin on the body.
  • Participants must be candidates for phototherapy (treatment using light) or systemic therapy (medicine that travels through the whole body, usually via pills or injections).
  • For the current part of the study, participants must be between 12 and 17 years old.
  • Participants in this group must weigh at least 40 kg.
  • Participants or their legally authorized representative (an adult who can make medical decisions for them) or caregiver must be able to understand and follow the study rules.
  • The participant or their caregiver must be confident that the person can swallow the medication.
  • The participant, their caregiver, or representative must sign the informed consent form, which is a document explaining the study details, and provide pediatric assent, which is the child’s agreement to participate.
  • Women of childbearing potential (any woman who could become pregnant) who are sexually active with a male partner must agree to use a highly effective method of contraception (preventing pregnancy), such as condoms, starting from the time they sign the study forms and continuing for 10 days after the last dose of the study medicine.
  • If a woman chooses to use hormonal contraception (like birth control pills), she must use a second method, such as a barrier method (like a male condom), because the study medicine might make the hormonal method less effective.
  • In certain regions, for participants who smoke or use tobacco, a doctor must confirm that the benefit-risk assessment (a check to see if the potential benefits of the study outweigh the risks) is favorable.
  • In certain regions, a doctor must confirm that the participant is not at an increased risk for serious side effects related to JAK inhibitors, which are a type of medicine that can affect the immune system.

Who Cannot Join the Study?

  • You cannot join if you have types of psoriasis other than plaque psoriasis, such as erythrodermic (skin redness covering most of the body), pustular (covered in small, pus-filled bumps), guttate (small, drop-shaped spots), inverse (occurring in skin folds), or drug-induced (caused by medication) psoriasis.
  • You cannot participate if you have used certain biologics (targeted medicines that act on specific parts of the immune system) or biosimilars (medicines very similar to an original biologic) within the last 2 to 6 months, depending on the specific drug.
  • You cannot participate if you have used medicated shampoos or body washes containing ingredients like salicylic acid, corticosteroids, or coal tar within 2 weeks of the study start.
  • You cannot participate if you have used topical medicines (creams or ointments) that change how psoriasis looks, such as retinoids or calcineurin inhibitors, within 2 weeks of the study start.
  • You cannot participate if you have taken systemic (medicines that travel through the whole body, such as pills or injections) non-biologic treatments like methotrexate or cyclosporine within 4 weeks of the study start.
  • You cannot participate if you have used leflunomide (a medication used for certain immune conditions) within the last 6 months.
  • You cannot participate if you have had phototherapy (light-based treatments like UVB or PUVA) or excimer laser treatments within the last 4 weeks.
  • You cannot participate if you have used botanical preparations (herbal supplements or traditional medicines) to treat psoriasis or immune diseases within the last 4 weeks.
  • You cannot participate if you have previously taken zasocitinib or other TYK2 inhibitors (a specific class of drugs used for immune-related conditions).
  • You cannot participate if you have taken lithium, antimalarials, or intramuscular gold therapy within the last 4 weeks.
  • You cannot participate if you are taking or have recently taken medicines that affect CYP3A4 (a specific enzyme in the liver that breaks down many drugs), including eating grapefruit or Seville oranges within 1 week of the study start.
  • You cannot participate if you require systemic treatment (medicine that affects the whole body) for other immune-related diseases, such as inflammatory bowel disease, during the study.
  • You cannot participate if you have received a live-attenuated vaccine (a vaccine using a weakened form of a germ) within the last 60 days or plan to get one during the study.
  • You cannot participate if you have used investigational (experimental) biological or oral therapies within the last 3 to 6 months.
  • You cannot participate if you are currently enrolled in another clinical trial.
  • You cannot participate if your blood tests show abnormal levels of liver enzymes (like AST, ALT, or ALP), hemoglobin (Hgb), white blood cells (WBC), platelets, or kidney function (measured by GFR).
  • You cannot participate if you have a history of severe drug allergy, such as anaphylaxis (a life-threatening allergic reaction), or a known allergy to the study medicine.
  • You cannot participate if you are pregnant, nursing, or planning to become pregnant during the study.
  • You cannot participate if you have donated a large amount of blood or plasma recently or plan to donate during the study.
  • You cannot participate if you have a history of excessive sun exposure or use tanning booths and are unwilling to limit sunlight during the study.
  • You cannot participate if you are compulsorily detained (legally required to stay) in a psychiatric or physical health facility or a prison.
  • You cannot participate if you are an employee or an immediate family member of an employee working on this study.
  • You cannot participate if you are not up to date on required vaccinations.
  • You cannot participate if you have other skin conditions that might make it hard for doctors to see the effects of the study medicine.
  • You cannot participate if you have Tuberculosis (TB), a history of active TB, or evidence of latent TB infection (TB that is present but not active/sickening) without proper treatment.
  • You cannot participate if you have active herpes infections (such as herpes zoster/shingles or herpes simplex) or a history of severe herpes complications.
  • You cannot participate if you have certain viral infections, including HCV (Hepatitis C), HBV (Hepatitis B), or HIV.
  • You cannot participate if you have had recent serious infections that required hospitalization or intravenous (delivered into a vein) medicine.
  • You cannot participate if you have unstable medical conditions affecting your heart, kidneys, liver, lungs, or immune system, such as hypertension (high blood pressure) or congestive heart failure.
  • You cannot participate if you have a history of malignancy (cancer), except for certain skin cancers that have been successfully treated.
  • You cannot participate if you have significant psychiatric illness or a history of substance abuse (drugs or alcohol) within the last 12 months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak Lodz Poland

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Hospital Universitario 12 De Octubre Madrid Spain
Azienda Ospedaliera di Padova Padua Italy
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Universidade De Santiago De Compostela Santiago De Compostela Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Citqpwu Bhpej Klflufbubpp Pfwjptff Ssx z osop Gdansk Poland
Tgyieohccje ulu Suvapukofyv Byvgefbi Grwo Bad Bentheim Germany
Gwpdfm Uppajclbdq Fwttltzlv Frankfurt Germany
Hcgglsju Dq Ls Srkuq Cpna I Sicp Ppr Barcelona Spain
Uqwddtkweh Hrgwsmda Cnmbfbt Cologne Germany
Uiupmlncwvqektmiojceg Mulczlrn Agy Munster Germany
Luhcevs Szrobavaqbhnmqt Gnupsnx Dytewycdugxujsl Lublin Poland

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

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
15.05.2026
Italy Italy
Not yet recruiting
15.05.2026
Poland Poland
Recruiting
15.05.2026
Spain Spain
Recruiting
15.05.2026

Trial locations

Investigated drugs:

Zasocitinib is a medication taken by mouth as a tablet. It is being studied to see how well it works and how safe it is for children and adolescents who have moderate-to-severe plaque psoriasis, a skin condition that causes red, itchy, and scaly patches.

Plaque psoriasis – This is a chronic skin condition characterized by the appearance of raised, red patches on the skin. These patches are often covered with thick, silvery scales. The condition is caused by an overactive immune system that speeds up the growth of skin cells. As the disease progresses, these rapidly produced cells build up on the surface of the skin, forming visible plaques. These areas may become itchy, sore, or cracked. The patches can vary in size and may appear on different parts of the body.

Trial ID:
2025-522567-15-00
Protocol code:
TAK-279-PsO-3006
Trial Phase:
Therapeutic confirmatory (Phase III)

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