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Taking people in ItalyPhase 3

Zasocitinib for Children and Teenagers With Plaque Psoriasis

Tests zasocitinib in children and teenagers with moderate-to-severe plaque psoriasis.

Key facts

Who runs it
Takeda
Where
Catania, Padova, and Rome, ItalySee the 3 sitesAlso in 6 other countries, 38 sites
Trial code
Registry title
A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
Status
Recruiting
Phase
Phase 3
People taking part
110 people, planned
Started
4 Dec 2025
Expected to end
24 Jan 2033
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Zasocitinib
  • Placebo
Record updated
9 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 4 to under 18 with stable, moderate-to-severe plaque psoriasis who could have light therapy or systemic treatment.

Age
4 to under 18 years. Part A Cohort 1: 12 to under 18 years. Part A Cohort 2 and Part B: 4 to under 12 years.
Sex
Males and females can join.
Disease stage
Chronic plaque psoriasis diagnosed at least 6 months before screening and stable for at least 6 months. Moderate-to-severe: PASI score of 12 or more, sPGA score of 3 or more, and psoriasis covering 10% or more of body surface area.
Earlier treatment
Must be a candidate for phototherapy or systemic therapy. Must not have had zasocitinib (TAK-279, NDI-034858) or other TYK2 inhibitors before, unless trial unblinding shows no TYK2 inhibitor was received. Vaccinations must be up to date.

Main reasons for not taking part

  • Other types of psoriasis, such as erythrodermic, pustular, mainly guttate, mainly inverse or drug-induced psoriasis
  • Active tuberculosis or latent tuberculosis infection
  • Active herpes infection, or a history of serious herpes infection
  • History of chronic or recurrent bacterial disease, or opportunistic infections
  • Needing systemic treatment (other than NSAIDs) for another immune-related disease during the trial

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Participant has a diagnosis of chronic plaque psoriasis for greater than or equal to (>=) 6 months prior to the screening visit
  • Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for >=6 months before screening
  • Participant has moderate-to-severe plaque psoriasis as defined by a Psoriasis Area and Severity Index (PASI) score >=12 and a Static Physician's Global Assessment (sPGA) score >=3 at screening and Day 1
  • Participant has plaque psoriasis covering >=10 percent (%) of total body surface area (BSA) at screening and Day 1
  • Participant must be a candidate for phototherapy or systemic therapy
  • Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to less than (<) 18 years, inclusive
  • Inclusion Criteria for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to <12 years, inclusive
  • Inclusion Criteria for Part A Cohort 1: The participant must weigh >=40 kilograms (kg) at the time of screening

Who cannot take part

  • Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary
  • Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments
  • Participant has any previous exposure to zasocitinib (also known as TAK-279 or NDI-034858) or other TYK2 inhibitors or participated in any trial that included a tyrosine kinase 2 (TYK2) inhibitor, unless participant has documentation of posttrial unblinding that confirms the participant did not receive a TYK2 inhibitor
  • Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related disease
  • Participant has history of active TB infection, regardless of treatment status and has signs or symptoms of active TB or evidence of latent tuberculosis infection (LTBI)
  • Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 or a history of serious herpetic infection
  • Participant has a history of chronic or recurrent bacterial disease
  • Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis)
  • Participant has any clinically significant medical condition, evidence of an unstable clinical condition or vital signs/physical examination/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results
  • Participant is not up to date on all required vaccinations according to current immunization guidelines as noted by country-specific pediatric authorities; Other protocol-defined inclusion/exclusion criteria apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 4 and 17 years old?

Where in Italy

Also in 6 other countries, 38 sites

  • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
  • Azienda Ospedaliera di PadovaPadova, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people

About the trial

What the trial wants to find out

The main aim of this study is to see how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it.

Read full original descriptionShow less

The study will be done in 2 parts: Part A will include both children and teenagers, while part B will only include children.

At first, only teenagers who meet the study rules can participate in this study. Children may only start to participate once enough information has been collected from other studies with zasocitinib.

Participants in Part A will initially be assigned to receive either zasocitinib or placebo for the first 16 weeks of treatment, then all participants will receive zasocitinib through the end of the study. All participants in Part B will be assigned to receive treatment with zasocitinib throughout the study.

Participants will be in the study for up to 4 years and 2 months (217 weeks), including up to 35 days for the screening period, 208 weeks of treatment (Part A and Part B) and a 4-week safety follow-up period. During the study, participants will visit their study site multiple times.

The 4 groups in the trial

  • Part A (Cohort 1): Zasocitinib (Dose A)Treatment being tested

    Participants (Adolescent) aged 12 to less than (\<)18 years will receive zasocitinib Dose A once daily (QD), orally, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib, from Week 16 to Week 208 during the open-label period.

    Treatment: Zasocitinib

  • Part A (Cohort 2): Zasocitinib (Multiple Doses)Treatment being tested

    Participants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib from Week 16 to Week 208 during the open-label period.

    Treatment: Zasocitinib

  • Part A (Cohort 1 and Cohort 2): PlaceboPlacebo, for comparison

    Participants in Cohort 1 (Adolescent aged 12 to \<18 years) and Cohort 2 (Children aged 4 to \<12 years) will receive zasocitinib matching placebo QD from Week 1 to Week 16 during the double-blind placebo-controlled period.

    Treatment: Placebo

  • Part B: Zasocitinib (Multiple Doses)Treatment being tested

    Participants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 208 during the open-label period.

    Treatment: Zasocitinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Plain-language title
Zasocitinib for Children and Teenagers With Plaque PsoriasisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07250802, who can take part
Record updated
9 September 2026