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RecruitingPHASE3INTERVENTIONAL

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

This study is investigating a new medication called zasocitinib for adults living with psoriatic arthritis. Psoriatic arthritis is a long-term condition that affects your joints and skin, especially if you have psoriasis. The main goal is to find out how effective zasocitinib is in people with active psoriatic arthritis, regardless of whether they've used other specific treatments in the past. Participants will either receive zasocitinib or a placebo (a dummy drug). The study will last for up to 60 weeks. This research hopes to provide more options for managing psoriatic arthritis symptoms.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Takeda
Enrolment target
600
Start
10 Mar 2025
Estimated completion
26 Jan 2028

What is this study about?

This study is all about a new potential medicine called zasocitinib. It's being tested for adults diagnosed with psoriatic arthritis. Psoriatic arthritis is a condition that causes inflammation in your joints and can affect your skin if you also have psoriasis. The idea is to see if zasocitinib can help reduce the symptoms of this condition.

The main question the researchers want to answer is: how well does zasocitinib work for people who have active psoriatic arthritis? They're especially interested in how it affects people who have or haven't tried certain other treatments for their condition before. To test this, some people will receive zasocitinib, while others will receive a placebo. A placebo looks like the real medicine but contains no active drug, which helps researchers understand if any improvements are truly due to the new drug.

Taking part in a study like this helps doctors learn more about new treatments. This information is really important because it could lead to new ways to help people manage their psoriatic arthritis in the future. The study will last for just over a year, around 60 weeks, to properly assess the effects of the treatment.

Key takeaways

  • The study is for adults with active psoriatic arthritis.
  • It's testing a new drug called zasocitinib against a dummy drug (placebo).
  • It includes people who have tried other psoriatic arthritis treatments and those who haven't.
  • Participation lasts about 60 weeks and involves regular clinic visits.
  • The aim is to find out how well zasocitinib helps manage psoriatic arthritis symptoms.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have received a diagnosis of psoriatic arthritis. Your psoriatic arthritis should have been active for at least three months, with a certain number of tender and swollen joints. You'll also need to have at least one active patch of psoriasis on your skin or changes to your nails typical of psoriasis.

The study is looking for people who haven't responded well to other common treatments for psoriatic arthritis. This could mean treatments like NSAIDs (painkillers), or standard disease-modifying drugs, or even up to two different biologic treatments.

However, you wouldn't be able to join if you have other conditions that might make it hard to tell if zasocitinib is working, such as rheumatoid arthritis, lupus, or gout. Also, if you have certain types of psoriasis that are not the ‘plaque’ type, or if your doctor thinks another skin condition might interfere with the study, you might not be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of psoriatic arthritis that's been active for at least 3 months?
  3. Do you have some tender and swollen joints?
  4. Do you have a patch of psoriasis or changes to your nails characteristic of psoriasis?
  5. Have you tried and not responded well to certain other psoriatic arthritis medicines in the past?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be in the study for up to 60 weeks (about 14 months). During this time, you'll either receive the new drug, zasocitinib, or a placebo (a dummy drug). You won't know which one you're getting, and neither will your study doctor, until the study is over. You'll have regular visits to the clinic where doctors will assess your joints, skin, and overall health to see how you're responding. There will also be follow-up appointments to monitor your progress and safety. All instructions for taking the medication will be given to you by the study team.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your health. However, there are also potential risks, as any new drug can have side effects that aren't fully known yet. You might not receive the active drug and could be given a placebo, meaning your symptoms might not improve. The research team will explain all known risks to you. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (122)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
    Verified postcode
    Mesa, United States· Recruiting
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
    Verified postcode
    Phoenix, United States· Recruiting
  • Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
    Verified postcode
    Tucson, United States· Recruiting
  • Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA
    Verified postcode
    Covina, United States· Recruiting
  • RASF- Clinical Research Center
    Verified postcode
    Boca Raton, United States· Recruiting
  • Direct Helpers Medical Center
    Verified postcode
    Hialeah, United States· Recruiting
  • IRIS Research and Development | Plantation, FL
    Verified postcode
    Plantation, United States· Recruiting
  • BayCare Medical Group
    Verified postcode
    St. Petersburg, United States· Recruiting
  • North Georgia Rheumatology Group PC
    Verified postcode
    Lawrenceville, United States· Recruiting
  • Clinic of Robert Hozman
    Verified postcode
    Skokie, United States· Recruiting
  • Graves Gilbert Clinic
    Verified postcode
    Bowling Green, United States· Recruiting
  • Johns Hopkins Hospital
    Verified postcode
    Baltimore, United States· Recruiting

Common questions

What is psoriatic arthritis?

Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis. It causes joint pain, stiffness, and swelling.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study drug but doesn't contain any active medicine. It helps doctors see if the real drug is truly effective.

How long will I be in the study?

You will be in the study for up to 60 weeks, which is about 14 months.

Will I have to pay for the treatment or visits?

No, all study-related treatments, tests, and visits are provided at no cost to you.

Can I leave the study at any time?

Yes, your participation is voluntary, and you can withdraw from the study whenever you want to, without giving a reason.

How to find out more

Takeda Contact

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Zasocitinib in Adults With Psoriatic Arthritis Wh…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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