All studies
RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

This research study is investigating a new medicine called icotrokinra (also known as JNJ-77242113) for adults living with active psoriatic arthritis. The main goal is to find out if this new medicine is effective at reducing the pain, swelling, and other common symptoms of psoriatic arthritis. We also want to understand if it is safe to use. Some participants in the study will have already tried other medications for their psoriatic arthritis, while others will be starting a new treatment path. To make sure we can compare the effects properly, some people will receive the new medicine, and others will receive a 'dummy' medicine (placebo) that looks the same but contains no active drug.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Enrolment target
750
Start
09 Jan 2025
Estimated completion
18 Oct 2028

What is this study about?

This study is designed to help us understand if a new medicine, called icotrokinra, can be an effective treatment for people with active psoriatic arthritis. Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis, causing joint pain, stiffness, and swelling. It can make everyday activities difficult.

The research aims to compare icotrokinra with a placebo, which is a 'dummy' medicine that has no active ingredients. This comparison is really important because it helps doctors and researchers determine the true effect of the new medicine. If the new medicine works better than the placebo, it suggests it could be a helpful option for people with psoriatic arthritis in the future. We'll be looking closely at whether it reduces the signs and symptoms of the condition.

Taking part in studies like this is vital because it helps bring new treatment options to people who need them. Without volunteers, we wouldn't be able to learn if new medicines are safe and effective. Everyone involved in the study will be carefully monitored by a medical team.

Key takeaways

  • This study is testing a new medicine (icotrokinra) for active psoriatic arthritis.
  • It aims to see if icotrokinra reduces joint pain and swelling and is safe to use.
  • Some participants will receive the new medicine, others a placebo (dummy medicine).
  • Participation involves regular clinic visits and health checks.
  • People with existing active psoriatic arthritis and certain skin psoriasis are eligible.
  • Volunteers are crucial for developing new treatments.

Who may be eligible?

To be able to join this study, you would need to be an adult (18 years or older) and have active psoriatic arthritis. This means you would have been diagnosed with psoriatic arthritis for at least 3 months and still experience noticeable joint pain and swelling, specifically at least 3 swollen and 3 tender joints. You would also need to have active psoriasis, such as a patch of skin psoriasis at least 2cm wide or changes to your nails caused by psoriasis.

It's important that your psoriatic arthritis hasn't responded well to at least one previous treatment, whether that was an older type of arthritis medicine (like a non-biologic DMARD), apremilast, or one biologic medicine. There are certain health conditions that would prevent you from taking part, such as having severe kidney, liver, heart, or lung problems, or a history of cancer within the last five years. Also, if you have other inflammatory conditions like rheumatoid arthritis, it's likely you wouldn't be able to join. If you are a woman who could become pregnant, you would need to have negative pregnancy tests before starting the study medicine.

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. Have you been diagnosed with psoriatic arthritis for at least 3 months?
  3. Do you currently have at least 3 swollen and 3 tender joints?
  4. Do you have active psoriasis, such as a skin patch of 2cm or more, or nail changes?
  5. Have you tried at least one other psoriatic arthritis treatment that didn't fully work?
  6. Do you have any serious existing health conditions like severe kidney, heart, or cancer within the last 5 years?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine, icotrokinra, or a placebo (a dummy medicine). You wouldn't know which one you are receiving. You would need to attend regular clinic visits where the study team would check your health, assess your psoriatic arthritis symptoms, and take blood samples. They would also monitor you closely for any side effects. The exact number of visits and the total length of your participation would be explained to you in detail by the study team, but typically these types of studies involve several visits over a period of many months.

Potential risks and benefits

Participating in this study could offer some potential benefits, such as gaining access to a new experimental medicine before it's widely available, and receiving close medical monitoring for your psoriatic arthritis. However, there are also potential risks, including the possibility of experiencing side effects from the study medicine, or that the medicine might not help your symptoms. Please remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (214)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • AARA Clinical Research
    Verified postcode
    Glendale, United States· Recruiting
  • AARA Clinical Research 1
    Verified postcode
    Mesa, United States· Recruiting
  • Arthritis and Rheumatism Associates ARA Jonesboro
    Verified postcode
    Jonesboro, United States· Recruiting
  • Clinical Research of West Florida
    Verified postcode
    Clearwater, United States· Recruiting
  • Omega Research Consultants
    Verified postcode
    DeBary, United States· Recruiting
  • Suncoast Clinical Research
    Verified postcode
    New Port Richey, United States· Recruiting
  • Integral Rheumatology And Immunology Specialists
    Verified postcode
    Plantation, United States· Recruiting
  • Clinical Research of West Florida 1
    Verified postcode
    Tampa, United States· Recruiting
  • Clinic of Robert Hozman
    Verified postcode
    Skokie, United States· Suspended
  • Klein And Associates M D P A
    Verified postcode
    Hagerstown, United States· Recruiting
  • DM Clinical Research 1
    Verified postcode
    Brookline, United States· Completed
  • St Paul Rheumatology PA
    Verified postcode
    Eagan, United States· Recruiting

Common questions

What is psoriatic arthritis?

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

What is icotrokinra?

Icotrokinra is a new medicine being tested to see if it can help reduce the symptoms of psoriatic arthritis.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real medicine but contains no active drug. It helps researchers understand if the new medicine really works.

Will I know if I'm getting the real medicine or the placebo?

No, during the study, neither you nor your study doctor will know whether you are receiving icotrokinra or the placebo. This helps ensure unbiased results.

Can I stop participating in the study at any time?

Yes, you are free to leave the study at any point and for any reason, without your regular medical care being affected.

How to find out more

Study 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 to Evaluate the Efficacy and Safety of Icotrokinra (…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.