RecruitingPHASE1INTERVENTIONAL

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

This study is looking into a new medicine called PIT565 for people who have rheumatoid arthritis. The main goal is to check how safe it is and how well people tolerate it. We'll also be learning how the medicine moves through the body. This is a very early stage (Phase 1) clinical trial, which means it's one of the first times this medicine is being tested in people. Participants will receive PIT565 as an injection under the skin. The study is open to both men and women aged 18 to 75 who have been diagnosed with rheumatoid arthritis. We are carefully checking for any potential health risks, especially heart conditions, to make sure it's as safe as possible for everyone involved.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Novartis Pharmaceuticals

Enrolment target

Start

12 Jun 2025

Estimated completion

16 May 2028

Rheumatoid Arthritis

What is this study about?

You're probably here because you're interested in new treatments for rheumatoid arthritis. This study is exploring a new medicine called PIT565. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. Finding new and effective ways to manage these symptoms is really important.

This study is an early step in testing PIT565. It's called a 'Phase 1' study, which means our main focus is on understanding if the medicine is safe and how well people tolerate it. We also want to learn how the medicine behaves in the body – for example, how long it stays in your system. We're starting with small doses and gradually increasing them to find the most suitable amount.

While this study isn't designed to tell us if PIT565 fully treats rheumatoid arthritis yet, the information we gather on safety and how the body handles it is vital. It helps us decide if PIT565 is promising enough to continue testing in larger studies, moving us closer to potentially new treatment options in the future.

Key takeaways

This study is testing a new medicine called PIT565 for rheumatoid arthritis.
It's an early-stage study (Phase 1) focused on safety and how the body handles the medicine.
Participants will receive the medicine as an injection under the skin.
Careful health checks, especially for heart conditions, are part of the eligibility.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old who has been diagnosed with rheumatoid arthritis for at least 12 weeks. Before you start, you'll need to read and sign a consent form, which explains everything about the study in detail. It's important that you have had your vaccinations for common illnesses like pneumonia, flu, meningitis, and COVID-19 at least two weeks before you receive the first study medicine.

There are certain health conditions that would prevent you from taking part, especially heart-related issues. For example, if you've had a heart attack, stroke, or major heart surgery within the last six months, or if you have certain serious heart rhythm problems or uncontrolled heart failure, this study might not be suitable for you. We also need to check your heart's electrical activity (a measure called QTcF) to make sure it's within a safe range.

Additionally, if you're taking any medicines that are known to affect your heart's electrical activity, you might not be able to join unless you can safely stop taking them for the duration of the study. A full review of your medical history will be done to ensure it's safe for you to participate.

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.

Are you between 18 and 75 years old?
Have you been diagnosed with rheumatoid arthritis for at least 12 weeks?
Have you had your pneumonia, flu, meningitis, and COVID-19 vaccinations at least 2 weeks ago?
Have you *not* had a heart attack, stroke, or major heart surgery in the last 6 months?
Do you *not* have serious, uncontrolled heart problems or certain heart rhythm issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study medicine, PIT565, as an injection under your skin. This is an "open-label" study, which means both you and the study team will know that you are receiving the active medicine. The study involves several visits to the clinic where doctors and nurses will monitor your health, take blood and urine samples, and ask you about any symptoms or side effects you might be experiencing. They will also perform physical examinations and check your vital signs regularly. The total duration of your involvement in the study will be explained to you when you consider joining, but it typically involves a screening period, a treatment period, and a follow-up period after your last dose.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as contributing to medical research and potentially gaining early access to a new treatment. However, there are also potential risks, as this is a new medicine and we don't yet know all of its effects. You might experience side effects from the medicine, and the study procedures (like blood tests) also carry some minor risks. Your safety is our top priority, and the study team will monitor you very closely. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Novartis Investigative Site
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CABA, Argentina· Recruiting
Novartis Investigative Site
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Sofia, Bulgaria· Recruiting
Novartis Investigative Site
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Beijing, China· Recruiting
Novartis Investigative Site
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Beijing, China· Recruiting
Novartis Investigative Site
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Brest, France· Recruiting
Novartis Investigative Site
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Le Kremlin-Bicêtre, France· Recruiting
Novartis Investigative Site
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Paris, France· Recruiting
Novartis Investigative Site
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Jena, Germany· Recruiting
Novartis Investigative Site
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Mainz, Germany· Recruiting
Novartis Investigative Site
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Szeged, Hungary· Recruiting
Novartis Investigative Site
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Leiden, Netherlands· Recruiting
Novartis Investigative Site
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Cluj-Napoca, Romania· Recruiting

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is an autoimmune disease where your body's immune system mistakenly attacks the lining of your joints, causing pain, swelling, and stiffness.

What does 'Phase 1 study' mean?

A Phase 1 study is an early stage of research where a new medicine is first tested in people. The main goals are to check if it's safe, find the right dose, and see how the body handles it.

Will PIT565 cure my rheumatoid arthritis?

This early study is focused on safety and how the body handles PIT565, not yet on whether it can cure the condition. More research would be needed to understand its full effects on symptoms.

What does 'subcutaneously' mean?

Subcutaneously means the medicine is given as an injection just under the skin, usually in places like your tummy or upper arm.

Will I have to pay to be part of the study?

No, you will not have to pay to participate in the clinical study. All study-related visits and medications will be provided without charge.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com +41613241111 Official trial record

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