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
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hunan Children's Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Dermatology Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Universitaetsklinikum Koeln AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Hospital of the University of Occupational and Environmental Health, Japan Coordinator of this site? Confirm its status | Kitakyushu-shi | Japan | Recruiting |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Nippon Life Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Teikyo University Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Recruiting |
| Mie University Hospital Coordinator of this site? Confirm its status | Tsu, Mie | Japan | Recruiting |
| Penta Hospitals Badania Kliniczne sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| UT Physicians Dermatology - Bellaire Station Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Apex Clinical Research Center, LLC Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Exalt Clinical Research Coordinator of this site? Confirm its status | Chula Vista | United States | Recruiting |
| Wright State Physicians Coordinator of this site? Confirm its status | Fairborn | United States | Recruiting |
| First Oc Dermatology Research Inc Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| Direct Helpers Medical Center Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
| Apex Clinical Research Center, LLC Coordinator of this site? Confirm its status | Mayfield Heights | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Arlington Dermatology Coordinator of this site? Confirm its status | Rolling Meadows | United States | Recruiting |
| Texas Dermatology and Laser Specialists-San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.