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New treatment option for Plaque Psoriasis
Official title A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
ClinicalTrials.gov ID: NCT07250802
What this study is testing
What is Zasocitinib?
Zasocitinib is an investigational medicine, being studied as a potential treatment for plaque psoriasis.
Also referred to as TAK-279, NDI-034858.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 4 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 17
You may be able to join if
- 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...
- Participant has moderate-to-severe plaque psoriasis as defined by a Psoriasis Area and Severity Index (PASI) score \>=12 and a Static Physician's...
- 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.
You likely can't join if
- Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced...
- Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related...
- Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
- Participant has history of active TB infection, regardless of treatment status and has signs or symptoms of active TB or evidence of latent...
- 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.
See the full eligibility criteria
- 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.
- for Part A Cohort 1: The participant is male or female and aged 12 to less than (\<) 18 years, inclusive.
- for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to \<12 years, inclusive.
- for Part A Cohort 1: The participant must weigh \>=40 kilograms (kg) at the time of screening.
- 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...
- Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related disease.
- Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
- 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chula Vista, California, United States
- Fountain Valley, California, United States
- Hialeah, Florida, United States
- Rolling Meadows, Illinois, United States
- Canton, Ohio, United States
- Fairborn, Ohio, United States
- Mayfield Heights, Ohio, United States
- Charleston, South Carolina, United States
- Bellaire, Texas, United States
- San Antonio, Texas, United States
- Milwaukee, Wisconsin, United States
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Changsha, Hunan, China
- Hangzhou, Zhejiang, China
- Beijing, China
- Shanghai, China
- Frankfurt am Main, Hesse, Germany
- Bad Bentheim, Lower Saxony, Germany
- Cologne, North Rhine-Westphalia, Germany
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chula Vista, California, United States; Fountain Valley, California, United States; Hialeah, Florida, United States; Rolling Meadows, Illinois, United States; Canton, Ohio, United States; Fairborn, Ohio, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.