A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
NCT ID: NCT07250802
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
110 participants
INTERVENTIONAL
2025-12-04
2033-01-24
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part A (Cohort 1): Zasocitinib (Dose A)
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.
Zasocitinib
Zasocitinib.
Part A (Cohort 2): Zasocitinib (Multiple Doses)
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.
Zasocitinib
Zasocitinib.
Part A (Cohort 1 and Cohort 2): Placebo
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.
Placebo
Zasocitinib matching placebo.
Part B: Zasocitinib (Multiple Doses)
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.
Zasocitinib
Zasocitinib.
Interventions
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Zasocitinib
Zasocitinib.
Placebo
Zasocitinib matching placebo.
Zasocitinib
Zasocitinib.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
4 Years
17 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Exalt Clinical Research
Chula Vista, California, United States
Direct Helpers Medical Center
Hialeah, Florida, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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2025-522567-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-279-PsO-3006
Identifier Type: -
Identifier Source: org_study_id