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Long-term zasocitinib treatment for 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

Phase 3 Interventional Takeda · NCT07250802

This long-term study will see if the medicine zasocitinib is safe and helps children and teenagers (ages 4 to under 18) with moderate-to-severe plaque psoriasis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment110 (estimated)
Ages4 Years to 17 Years
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionszasocitinib
Locations40 sites (Chula Vista, California and 39 other locations)
Trial IDNCT07250802 on ClinicalTrials.gov

What this trial studies

The study has two parts: Part A enrolls teenagers and begins with a 16-week randomized phase where participants receive either zasocitinib or placebo, after which all participants receive zasocitinib; Part B enrolls children who will receive zasocitinib throughout. Enrollment initially opens to teenagers only, with younger children added once sufficient safety data are available from other zasocitinib studies. Participants must have chronic, stable, moderate-to-severe plaque psoriasis (PASI ≥12, sPGA ≥3, BSA ≥10%) and be candidates for phototherapy or systemic therapy. Total participation can last up to about 4 years and 2 months, including screening and up to 208 weeks of treatment.

Who should consider this trial

Good fit: Ideal candidates are children and teenagers aged 4 to under 18 with chronic, stable moderate-to-severe plaque psoriasis (PASI ≥12, sPGA ≥3, BSA ≥10%) who are candidates for phototherapy or systemic therapy, noting that teenagers are enrolled first and younger children join later.

Not a fit: Patients with mild psoriasis, non-plaque forms of psoriasis, children under 4 years old, or those with unstable or rapidly changing disease are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a long-term oral treatment option that reduces psoriasis severity and improves quality of life for pediatric patients.

How similar studies have performed: Prior adult and adolescent trials of zasocitinib and similar oral JAK/TYK-pathway inhibitors have shown efficacy in plaque psoriasis, but long-term pediatric safety and effectiveness data remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participant has a diagnosis of chronic plaque psoriasis for greater than or equal to (\>=) 6 months prior to the screening visit.
2. 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.
3. 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.
4. Participant has plaque psoriasis covering \>=10 percent (%) of total body surface area (BSA) at screening and Day 1.
5. Participant must be a candidate for phototherapy or systemic therapy.
6. Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to less than (\<) 18 years, inclusive.
7. Inclusion Criteria for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to \<12 years, inclusive.
8. Inclusion Criteria for Part A Cohort 1: The participant must weigh \>=40 kilograms (kg) at the time of screening.

Exclusion Criteria:

1. 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.
2. Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related disease.
3. Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
4. 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).
5. Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 or a history of serious herpetic infection.
6. Participant has a history of chronic or recurrent bacterial disease.
7. Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
8. 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.
9. 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.
10. 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.

Where this trial is running

Chula Vista, California and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Plaque PsoriasisDrug Therapy
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.