Not yet recruiting

A study to evaluate the effectiveness and safety of JNJ-88545223 in people with active psoriatic arthritis

Fast replyInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the effectiveness and safety of the drug JNJ-88545223 for people living with Psoriatic Arthritis. Psoriatic Arthritis is a type of inflammatory disease that causes joint pain, swelling, and stiffness, often occurring in people who also have psoriasis, a skin condition characterized by red, itchy patches.

Participants in this research will receive different doses of the tablet form of JNJ-88545223 or a placebo. The study is randomized, meaning participants are assigned to a specific group by chance, and double-blind, which means neither the participants nor the researchers know which treatment is being given. This process is used to ensure the results are as objective as possible.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
After joining the study, a randomized process occurs, which means a method is used to decide whether a test medication or a placebo is received. a placebo is a substance that looks like the medicine but contains no active ingredients.
The study is double-blind, meaning neither the person participating nor the medical staff know which specific substance is being taken during the process.
Step 2
Medication administration
The test medication, known as JNJ-88545223, is taken in the form of a tablet. this medication is used for oral use, meaning it is swallowed.
The dosage for the test medication is determined by the specific group assigned during the dose-ranging phase of the study.
Step 3
Evaluation of treatment
The effects of the treatment are monitored to evaluate the efficacy, which refers to how well the medication works, and safety.
At week 16, a specific measurement called the ACR50 response is evaluated. this is a standard way to check if there is a 50% improvement in signs and symptoms of psoriatic arthritis, a type of inflammatory arthritis.

Who can join the trial?

16 criteria

You must be 18 years of age or older.
You must have been diagnosed with psoriatic arthritis (a type of arthritis that affects people who also have psoriasis) for at least 3 months.
You must meet specific medical standards for psoriatic arthritis during the initial check-up.
You must have active disease, which is defined as having at least 3 swollen joints and 3 painful joints during the screening and at the start of the study.
You must have a high enough level of CRP, which is a blood marker that shows there is inflammation in your body.
You must have active plaque psoriasis, which means having at least one skin patch that is at least 2 cm wide, or having nail changes caused by psoriasis.
Your disease must still be active even though you have used or are currently using at least one of the following types of medicine: conventional DMARDs (medicines that help slow down the disease), apremilast, or anti-TNF agents (a specific type of biological medicine).
If you are taking conventional DMARDs, you must have taken them for at least 12 weeks, or you must have been unable to take them due to intolerance (meaning the medicine caused bad side effects).
If you are using anti-TNF agents, you must have either not had a good response to the medicine after 12 to 14 weeks, or you must have stopped taking them because of safety or tolerability issues.
If you are currently taking conventional DMARDs, your dose must have been stable (not changed) for at least 4 weeks, and you must not have any serious toxic side effects from the medicine.
If you are not currently taking certain DMARDs, you must have stopped taking them for at least 4 weeks (for some) or 12 weeks (for others) before starting the study.
Specific dose limits must be met for medicines like methotrexate, sulfasalazine, hydroxychloroquine, and leflunomide.
If you are taking apremilast, you must be on a stable dose for at least 12 weeks before the study begins.
If you are not taking apremilast, you must have stopped taking it at least 4 weeks before the study starts.
If you use NSAIDs (pain relievers like ibuprofen) or other analgesics (painkillers) for your arthritis, you must have been on a stable dose for at least 2 weeks, or have been off them for at least 2 weeks.
If you use oral corticosteroids (steroid pills used to reduce inflammation), you must be on a stable dose for at least 2 weeks, or have been off them for at least 2 weeks.

Who cannot join the trial?

6 criteria

You have a history of or are currently showing signs of serious, worsening, or poorly managed problems with your kidneys (renal), liver (hepatic), heart (cardiac), blood vessels (vascular), lungs (pulmonary), digestive system (gastrointestinal), hormone system (endocrine), nervous system (neurologic), blood (hematologic), joints and bones (rheumatologic), mental health (psychiatric), urinary or reproductive system (genitourinary), or chemical processes in the body (metabolic).
You currently have cancer (malignancy) or have had cancer within the last 5 years, unless it was a specific type of skin cancer or a specific type of early-stage cervical cancer that has been fully treated and has not returned for at least 12 weeks.
You have other diseases that cause swelling or redness in the body (inflammatory diseases) that could make it difficult to see if the study medication is actually working.
Your blood tests show levels of rheumatoid factor or anti-CCP antibodies (specific proteins in the blood often linked to certain types of arthritis) that are higher than the upper limit of normal (ULN), which is the highest level considered healthy by a laboratory.
You have an active infection of the liver (hepatitis) caused by a virus or other germ.
You have a history of long-lasting or repeating infections (chronic or recurrent infectious disease).

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Responsive
Semmelweis University
Budapest, Hungary

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

JNJ-88545223 is an experimental medication taken by mouth in tablet form. It is being studied to see how well it works and how safe it is for people who have active psoriatic arthritis.

What is already known about the treatment

JNJ-88545223 - This medication is taken as a tablet by mouth and is currently being studied in clinical trials to treat active psoriatic arthritis. It belongs to a class of drugs known as targeted therapies that work by blocking specific proteins in the immune system to reduce swelling and pain. By interfering with these signals at a molecular level, it helps prevent the body from attacking its own joints and skin.

Investigated diseases

Psoriatic Arthritis - This is a type of inflammatory arthritis that affects some people who have psoriasis, a skin condition. The disease causes inflammation in the joints, which can lead to swelling and pain. It may also affect the skin, nails, and other parts of the body. Over time, the inflammation can cause damage to the joints and change their shape. The condition often moves through periods of activity and periods of relative calm.