This clinical trial is focused on studying the effects of a medication called zasocitinib (also known as TAK-279) in adults with Psoriatic Arthritis. Psoriatic Arthritis is a type of arthritis that affects some people who have psoriasis, a condition that features red patches of skin topped with silvery scales. The study aims to evaluate how effective and safe zasocitinib is for individuals who have not previously taken biologic medicines, which are advanced drugs used to treat various diseases.
Participants in the study will be randomly assigned to receive either zasocitinib, a matching placebo, or another active treatment. A placebo is a substance with no active medication, used to compare the effects of the actual drug. The study will last for up to 52 weeks, during which participants will take the medication in the form of film-coated tablets. The goal is to see if zasocitinib can improve the symptoms of Psoriatic Arthritis, such as joint pain and swelling, compared to the placebo and other treatments.
Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The study will assess various outcomes, including improvements in joint symptoms and overall quality of life. This research is important for understanding how zasocitinib can help people with Psoriatic Arthritis and potentially offer a new treatment option for those affected by this condition.
1initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed. This includes checking your medical history and current health status to ensure you meet the study requirements.
You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the procedures and potential risks involved.
2baseline assessment
A baseline assessment will be conducted to record your current health status. This includes evaluating your psoriatic arthritis symptoms, such as joint tenderness and swelling.
You may also undergo additional tests to assess your overall health and any specific conditions related to psoriatic arthritis.
3randomization
You will be randomly assigned to one of the treatment groups. This means you could receive either the study medication zasocitinib at Dose A or Dose B, a placebo, or an active comparator like Otezla.
The study is double-blind, meaning neither you nor the study team will know which treatment you are receiving to ensure unbiased results.
4treatment phase
During the treatment phase, you will take the assigned medication orally. If you are in the zasocitinib group, you will receive either Dose A or Dose B. If you are in the Otezla group, you will take 10mg, 20mg, or 30mg film-coated tablets.
The medication will be taken as directed by the study team, and you will continue this treatment for the duration specified by the study protocol.
5follow-up visits
You will attend regular follow-up visits to monitor your health and the effects of the treatment. These visits will include assessments similar to the baseline assessment to track any changes in your condition.
The study team will also check for any side effects or adverse reactions to the medication.
6end of treatment evaluation
At the end of the treatment period, a final evaluation will be conducted. This will involve a comprehensive assessment of your psoriatic arthritis symptoms and overall health.
The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.
Who Can Join the Study?
The person must be willing and able to understand and follow all study procedures and requirements.
If the person is taking other treatments, they must be at stable doses:
Oral corticosteroids (no more than 10 mg/day of prednisone equivalent)
NSAIDs (non-steroidal anti-inflammatory drugs) or paracetamol/acetaminophen
Low-potency opiates (only tramadol up to 300 mg/day or a combination of acetaminophen and codeine or hydrocodone)
These must be stable for at least 1 week before the first day of the study.
The person must meet specific birth control requirements if they can become pregnant:
Be surgically sterile, or
Be of non-childbearing potential with lab confirmation of postmenopausal status, or
If sexually active with a non-sterilized partner, agree to use a highly effective method of contraception during the study and for 10 days after the last dose.
Note: If using oral hormonal contraception, a second method should be used as it may interact with the study drug.
For people aged 65 years or older, a benefit-risk assessment must be done by the investigator to justify participation.
For people who smoke or have a history of long-term smoking (20 pack years or more), a benefit-risk assessment must be done by the investigator to justify participation.
For those using hormonal contraception, a benefit-risk assessment must be done by the investigator to justify participation.
The person must provide written informed consent before starting any study procedures.
The person must be 18 years or older at the time of signing the consent form.
The person must have had signs and symptoms of Psoriatic Arthritis (PsA) for at least 3 months.
The person must meet the CASPAR criteria (a set of guidelines used to diagnose Psoriatic Arthritis).
The person must have active arthritis with at least 3 tender and 3 swollen joints at the screening and baseline visits.
The person must have at least one active lesion of plaque psoriasis (a skin condition) that is 2 cm or larger, or any nail changes characteristic of psoriasis.
The person must have had an inadequate response to an NSAID after at least 4 weeks of therapy, or an inadequate response to a csDMARD (conventional synthetic disease-modifying antirheumatic drug) after at least 12 weeks of therapy, or intolerance to a csDMARD.
If the person is taking csDMARDs at the start of the study, they must be on no more than 2 csDMARDs for at least 12 weeks, with stable doses for at least 4 weeks before the first day of the study. Specific dose limits apply to certain drugs.
Who Cannot Join the Study?
Patients who do not have active psoriatic arthritis cannot participate. Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis, a condition that features red patches of skin topped with silvery scales.
Patients who are not within the specified age range for the study cannot participate. The study is open to 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.
Zasocitinib is a medication being studied for its potential to help people with psoriatic arthritis, a condition that causes joint pain and swelling. This medication works by targeting specific pathways in the immune system that are involved in inflammation. By doing so, it aims to reduce the symptoms of psoriatic arthritis, such as pain and swelling, and improve the overall quality of life for those affected by this condition. The study is exploring how effective and safe this medication is for people who have not previously been treated with certain types of arthritis medications known as biologic disease-modifying antirheumatic drugs.
Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It typically occurs in individuals with psoriasis, a skin disease characterized by red, scaly patches. The disease progresses with joint pain, stiffness, and swelling, which can lead to reduced range of motion and joint damage over time. Symptoms may vary in severity and can affect any joint, including those in the fingers and toes, often causing a sausage-like swelling known as dactylitis. Enthesitis, or inflammation where tendons and ligaments attach to bone, is also common. The disease can fluctuate, with periods of increased activity and remission.
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