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NCT07250802RecruitingPhase 3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

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

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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. 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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
110 (estimated)
First submitted
18 Nov 2025
Start date
4 Dec 2025
Primary completion date
24 Jan 2033
Lead sponsor
Takeda
Diseases
Psoriasis
NCT number
NCT07250802
EU CT number
2025-522567-15-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 110
  • From 4 Dec 2025 to the primary completion date, 24 Jan 2033
  • 41 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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).

Lab values

  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 4 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Children Hospital, Capital Medical University
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BeijingChinaRecruiting
Peking University Third Hospital
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BeijingChinaRecruiting
Hunan Children's Hospital
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ChangshaChinaRecruiting
Dermatology Hospital of Southern Medical University
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GuangzhouChinaRecruiting
Hangzhou First People's Hospital
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HangzhouChinaRecruiting
Huashan Hospital, Fudan University
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ShanghaiChinaRecruiting
Thermalsole und Schwefelbad Bentheim GmbH
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Bad BentheimGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Universitaetsklinikum Koeln AöR
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CologneGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
Universitaet Muenster
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MuensterGermanyRecruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyRecruiting
Azienda Ospedaliera di Padova
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PadovaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Hospital of the University of Occupational and Environmental Health, Japan
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Kitakyushu-shiJapanRecruiting
Nagoya City University Hospital
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NagoyaJapanRecruiting
Nippon Life Hospital
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OsakaJapanRecruiting
Teikyo University Hospital
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tabashi CityJapanRecruiting
Mie University Hospital
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Tsu, MieJapanRecruiting
Penta Hospitals Badania Kliniczne sp. z o.o.
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GdanskPolandRecruiting
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
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LodzPolandRecruiting
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandRecruiting
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska
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LublinPolandRecruiting
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
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RzeszówPolandRecruiting
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
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WroclawPolandRecruiting
UT Physicians Dermatology - Bellaire Station
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BellaireUnited StatesRecruiting
Apex Clinical Research Center, LLC
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CantonUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Exalt Clinical Research
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Chula VistaUnited StatesRecruiting
Wright State Physicians
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FairbornUnited StatesRecruiting
First Oc Dermatology Research Inc
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Fountain ValleyUnited StatesRecruiting
Direct Helpers Medical Center
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HialeahUnited StatesRecruiting
Apex Clinical Research Center, LLC
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Mayfield HeightsUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Arlington Dermatology
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Rolling MeadowsUnited StatesRecruiting
Texas Dermatology and Laser Specialists-San Antonio
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San AntonioUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.