Long-term zasocitinib treatment for children and teenagers with plaque psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Exalt Clinical Research
  Chula Vista, California, United States Recruiting
• First OC Dermatology Research Inc.
  Fountain Valley, California, United States Recruiting
• Direct Helpers Medical Center
  Hialeah, Florida, United States Recruiting
• Arlington Dermatology
  Rolling Meadows, Illinois, United States Recruiting
• Apex Clinical Research Center, LLC
  Canton, Ohio, United States Recruiting
• Wright State Physicians
  Fairborn, Ohio, United States Recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.