All studies
Active not recruitingPHASE3INTERVENTIONAL

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

This research study is looking at a new medicine, called icotrokinra, for people living with psoriatic arthritis. This condition causes joint pain and swelling, as well as skin problems. If you have active psoriatic arthritis and haven't previously used certain types of powerful medicines called biologics, you might be able to take part. The main aim of the study is to find out if icotrokinra can help reduce the signs and symptoms of psoriatic arthritis more effectively than a dummy treatment (placebo). We'll also compare it to another established treatment. Additionally, an important part of the study is to check if icotrokinra is safe to use. By taking part, you could contribute to understanding new ways to treat psoriatic arthritis.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Enrolment target
552
Start
21 Feb 2025
Estimated completion
04 Feb 2028

What is this study about?

This study is about exploring a new medicine called icotrokinra for people who have psoriatic arthritis. Psoriatic arthritis is a type of arthritis that can affect people who have psoriasis, causing joint pain, swelling, and stiffness, often alongside skin rashes. We're particularly interested in people who haven’t tried 'biologic' medicines—a powerful class of drugs used to treat these conditions—before.

The main goal is to see how well icotrokinra helps to reduce the symptoms of psoriatic arthritis. This includes looking at things like how many joints are swollen or tender. We're also carefully checking for any side effects to make sure the medicine is safe. To get reliable answers, some participants will receive the new medicine, others will get a 'placebo' (a dummy treatment with no active medicine), and some will receive an existing treatment that is already approved. This helps us compare the new medicine fairly.

Learning more about icotrokinra could be really important because it might offer a new treatment option for people with psoriatic arthritis in the future. By joining this study, you would be helping researchers understand better ways to manage this long-term condition and potentially improve the lives of many people.

Key takeaways

  • This study is testing a new medicine called icotrokinra for psoriatic arthritis.
  • It's for adults with active psoriatic arthritis who haven't tried 'biologic' medicines before.
  • The study compares icotrokinra to a dummy medicine (placebo) and an existing treatment.
  • It aims to find out if icotrokinra can reduce symptoms and if it's safe.
  • Taking part involves regular clinic visits for check-ups and tests.
  • You can leave the study at any time without affecting your normal care.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with psoriatic arthritis for at least three months. To be considered, your psoriatic arthritis needs to be 'active,' meaning you have a certain number of swollen and tender joints, and a blood test shows signs of inflammation. You should also have at least one type of psoriatic arthritis that affects specific joints or your spine, and at least one patch of active psoriasis on your skin or nail changes related to psoriasis.

It's important that you have not previously received any 'biologic' medicines for your psoriatic arthritis or psoriasis. People with other serious illnesses affecting their organs like kidneys, liver, or heart, or other inflammatory diseases like rheumatoid arthritis, cannot join. Also, if you have severe allergies to the study medicine or its ingredients, or if other conditions like fibromyalgia might make it hard to measure how well the treatment is working, you would not be able to participate. Women who could become pregnant will need to take pregnancy tests and use effective contraception during the study.

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. I am 18 years old or older.
  2. I have been diagnosed with psoriatic arthritis for at least 3 months.
  3. My psoriatic arthritis is currently active (with specific joint swelling/tenderness).
  4. I have not previously taken 'biologic' medicines for my psoriatic arthritis or psoriasis.
  5. I do not have other serious health problems that might affect the study results (like serious kidney, liver, or heart issues).
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the new medicine (icotrokinra), a dummy medicine (placebo), or an existing treatment. This would involve regular visits to the clinic for check-ups, where doctors and nurses would monitor your psoriatic arthritis symptoms by examining your joints and asking about your well-being. You would also have blood tests and other assessments to check your general health and see how the treatment is affecting you.

More detailed information about visit schedules, specific tests, and the total length of the study would be given to you by the study team. They will explain everything you need to know before you make a decision. Remember, you can ask as many questions as you like throughout the process.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring from experts. Your participation also helps advance medical knowledge, potentially benefiting future patients. However, there are also potential risks, including side effects from the study medication, which might be unknown or different from those of existing treatments. There's also a chance you might receive the placebo (dummy treatment), meaning your symptoms might not improve. All potential risks and benefits will be fully explained before you consent to join, and you are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (155)

  • Arthritis and Rheumatism Associates ARA Jonesboro
    Verified postcode
    Jonesboro, United States
  • Omega Research Consultants
    Verified postcode
    DeBary, United States
  • Integral Rheumatology And Immunology Specialists
    Verified postcode
    Plantation, United States
  • Clinical Research of West Florida
    Verified postcode
    Tampa, United States
  • Willow Rheumatology and Wellness PLLC
    Verified postcode
    Willowbrook, United States
  • Joint and Muscle Research Institute
    Verified postcode
    Charlotte, United States
  • Altoona Center For Clinical Research
    Verified postcode
    Duncansville, United States
  • Arthritis and Rheumatology Research Institute
    Verified postcode
    Allen, United States
  • Naiara Alvarez MD Integrative Rheumatology of South TX
    Verified postcode
    Harlingen, United States
  • Cosultorios Reumatologógicos Pampa
    Verified postcode
    Buenos Aires, Argentina
  • Mindout Research
    Verified postcode
    Buenos Aires, Argentina
  • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
    Verified postcode
    Buenos Aires, Argentina

Common questions

What is psoriatic arthritis?

Psoriatic arthritis is a type of arthritis that causes joint pain, swelling, and stiffness in people who often also have a skin condition called psoriasis.

What are 'biologics' and why haven't I used them?

Biologics are a strong group of medicines made from living cells that target specific parts of the immune system. This study is specifically for people who are trying a new type of treatment before starting biologics.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps us fairly compare the new medicine's effects.

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

No, in this type of study, neither you nor your study doctor will know which treatment you are receiving until after the study is complete. This helps keep the results unbiased.

How long will the study last?

The study team will explain the exact duration during the consent process. Clinical trials often last for several months or even a few years.

How to find out more

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

Discussion

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