RightFit
RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
4 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 years, 35 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well zasocitinib works and how safe it is for children and teens ages 4 to under 18 with moderate-to-severe plaque psoriasis, which causes raised, scaly skin patches. Only teens can join at first; younger children can join once enough information from other studies is available. The study lasts up to 4 years and 2 months, and some participants get a placebo (a treatment with no study medicine) for the first 16 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had plaque psoriasis for at least 6 months.
  • Have had no major flare-up or change in how the psoriasis looks for at least 6 months.
  • Have moderate-to-severe psoriasis at screening and Day 1, with skin rating scores of PASI 12 or higher and sPGA 3 or higher.
  • Have psoriasis covering at least 10% of the body at screening and Day 1.
  • Be able to receive light therapy or medicine that treats the whole body.
  • For Part A, group 1: be age 12 to under 18 and weigh at least 40 kilograms at screening.
  • For Part A, group 2, or Part B: be age 4 to under 12.

Who can't join

  • Have a type of psoriasis other than plaque psoriasis. A small amount of inverse psoriasis, which affects skin folds, may be allowed.
  • Need whole-body treatment for an immune-related disease during the study, other than NSAIDs (medicines for pain and swelling).
  • Have another skin condition that could affect study checks.
  • Have a history of active tuberculosis (TB), signs of active TB, or a hidden TB infection, even without symptoms.
  • Have an active herpes infection, such as shingles or herpes simplex, or a past serious herpes infection.
  • Have a history of long-lasting or repeated bacterial infections, or infections that often occur when the body's defenses are weak.
  • Have another health problem or abnormal test result that the study doctor thinks could make joining unsafe or affect the results.
  • Have received zasocitinib or another TYK2 inhibitor (a related type of medicine), or joined a study of one unless records show you did not receive it; or are missing required vaccines for your country.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (11)

CA

FL

IL

OH

SC

TX

WI