This clinical trial is focused on studying the long-term effects of a medication called Zasocitinib (also known by its code name TAK-279) in individuals with moderate-to-severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. The purpose of the study is to evaluate how safe and tolerable the medication is when taken over an extended period.
Participants in the study will take Zasocitinib in the form of a film-coated tablet, which is taken orally once a day. The study will monitor participants over a period of time to observe any side effects or changes in their condition. The study aims to see if the medication can help improve the symptoms of plaque psoriasis, such as reducing the size and severity of the skin patches.
Throughout the study, researchers will keep track of any adverse events, which are any unwanted effects that occur while taking the medication. They will also look for improvements in the condition, such as a significant reduction in the psoriasis area and severity. The study is designed to provide valuable information about the long-term use of Zasocitinib for treating moderate-to-severe plaque psoriasis.
1initial assessment
The study begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.
Eligibility criteria include having moderate-to-severe plaque psoriasis and being a candidate for phototherapy or systemic therapy.
2consent and compliance
Written informed consent is required before any study procedures begin.
Participants must agree to comply with study procedures, including the use of digital tools if necessary.
3medication administration
The medication TAK-279 is administered orally once daily.
The form of the medication is a film-coated tablet.
4ongoing monitoring
Participants are monitored for any treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Regular assessments are conducted to evaluate the improvement in psoriasis symptoms, such as the Psoriasis Area and Severity Index (PASI) and the Static Physician Global Assessment (sPGA).
5duration of participation
The study is designed to evaluate long-term safety and efficacy, with participation potentially lasting until the estimated end date in May 2026.
Participants who have completed previous related studies may continue their treatment in this study.
Who Can Join the Study?
The person must be willing and able to understand and follow all study procedures and requirements, including using digital tools and applications if needed.
The person must provide written informed consent and any required privacy authorization before starting any study procedures.
The person must be 18 years or older. In the EU/EEA and the UK, if the person is 65 years or older, the investigator must ensure that participating in the study is safe for them.
The person must have a diagnosis of chronic plaque psoriasis for at least 6 months before the screening visit.
The person must have stable plaque psoriasis, meaning no significant worsening or change in the condition for at least 6 months before screening.
The person must have moderate-to-severe plaque psoriasis, which is determined by specific scores (PASI score of 12 or more and sPGA score of 3 or more) at screening and on the first day of the study.
The person must have plaque psoriasis covering at least 10% of their total body surface area at screening and on the first day of the study.
The person must be a candidate for phototherapy (light treatment) or systemic therapy (treatment affecting the whole body).
If the person is capable of becoming pregnant, they must meet certain birth control requirements. This includes being of nonchildbearing potential or agreeing to use a highly effective method of contraception during the study and for 10 days after the last dose. If using hormonal contraception, a second method should be used to ensure effectiveness.
The person must have completed 52 weeks of treatment in a previous related study or 60 weeks in another related study.
Participation in the study should not put the person at undue risk or interfere with the study results, as determined by the investigator.
For participants in the EU/EEA or UK, the investigator must ensure that participating in the study does not pose a risk based on specific guidelines related to JAK inhibitors, which are medications that can affect the immune system.
If the person currently smokes or uses chewing tobacco, or has a history of long-term use, the investigator must ensure that the benefits of participating in the study outweigh any risks.
Who Cannot Join the Study?
Patients who do not have moderate to severe plaque psoriasis cannot participate. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
Patients who are not within the specified age range for the study cannot participate. The study is for adults.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship with the study staff, cannot participate.
TAK-279 is a medication being studied for its long-term safety, tolerability, and effectiveness in treating moderate-to-severe plaque psoriasis. It is taken by mouth once a day. The study aims to understand how well patients can tolerate the medication over an extended period and how effective it is in managing the symptoms of psoriasis, which is a skin condition that causes red, scaly patches.
Moderate to Severe Plaque Psoriasis – This is a chronic skin condition characterized by the rapid growth of skin cells, leading to thick, red, scaly patches on the skin. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but they can occur anywhere on the body. The condition is caused by an overactive immune system that speeds up the growth cycle of skin cells. Symptoms can include itching, burning, and soreness around the affected areas. The severity of the condition can vary, with some individuals experiencing only minor irritation, while others may have extensive and painful plaques. The disease tends to go through cycles, with periods of flare-ups followed by times of remission.
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