Active not recruitingPHASE1, PHASE2INTERVENTIONAL

An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus

This research study is looking at a new medicine called YTB323 for people with systemic lupus erythematosus (lupus), specifically those with severe forms that haven't improved with other common treatments. The main goals are to understand if YTB323 is safe to use, how effective it is at treating lupus symptoms, and how it works within the body, especially on your cells. The study includes both men and women between 18 and 65 years old. This is an 'open-label' study, meaning both you and the study doctors will know you are receiving YTB323. The findings from this study will help us learn more about this potential new treatment for lupus.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

Start

28 Feb 2023

Estimated completion

24 Sep 2026

Systemic Lupus Erythematosus Lupus Nephritis

What is this study about?

Lupus, or Systemic Lupus Erythematosus (SLE), is a long-term condition where your body's immune system mistakenly attacks your own healthy tissues. This can cause problems in many parts of your body, including your joints, skin, kidneys, heart, and lungs. Some people with lupus have severe forms of the disease that don't get better with standard treatments. This can be very challenging and significantly impact their daily lives.

This study, called YTB323, is focused on finding new ways to help people with severe lupus who haven't responded to other medicines. Scientists are testing a new treatment which they hope could offer relief. They want to understand if this new medicine is safe for people to take, how well it helps control lupus symptoms, and how it affects the body's cells at a very basic level. This type of research is important because it could lead to new treatment options for those who currently struggle with their lupus.

By taking part in studies like this, volunteers help doctors and scientists learn more about lupus and discover potential new medicines. The information gathered from participants can make a big difference in improving the lives of many people living with this chronic condition in the future.

Key takeaways

This study is for severe lupus that hasn't responded to other treatments.
It's testing a new medicine called YTB323.
Researchers are checking its safety and how well it works.
Participants must be 18-65 years old with active, serious lupus.
You'll know if you're receiving the study medicine.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be a man or a woman with lupus, aged between 18 and 65. Your lupus must be active and severe, and you should have already tried at least two other strong lupus medicines (like mycophenolate or cyclophosphamide) and a biological medicine, without success, or you couldn't take them due to side effects or medical reasons. You'll also need to show signs of lupus in your blood tests and have serious involvement in parts of your body like your kidneys, heart, or lungs.

There are also some reasons why you might not be able to join. For example, if you have any active, serious infections – including COVID-19 – or if you've had certain severe infections in the past. If you have conditions like uncontrolled diabetes, serious lung problems not related to lupus, or any other significant health issues that the study doctors feel would make it unsafe for you to participate, you would also not be eligible.

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 65 years old?
Do you have lupus (SLE) that has been diagnosed by a doctor?
Is your lupus currently active and severe?
Have you tried at least two different strong lupus medicines and a biological medicine, but they haven't worked well for you or you couldn't take them?
Do you have good kidney, liver, heart, and lung function overall?
Do you NOT have any serious active infections like COVID-19?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be given the investigational medicine YTB323. Because this is an 'open-label' study, both you and the study team will know you are receiving this medicine. You will have regular visits to the clinic so the doctors can monitor your health, check for any side effects, and see how the medicine is affecting your lupus. These visits will likely include physical examinations, blood tests, and other assessments to track your progress and how the medicine is working. The study team will explain the full schedule of visits and tests during the consent process. The total duration of your involvement in the study will be clearly explained before you agree to take part.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit: you could receive a new treatment for your severe lupus that hasn't responded to other medicines. However, as with any new treatment, there are also potential risks. The medicine YTB323 might cause side effects, and some of these could be serious. The study team will explain all known or expected risks before you agree to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Novartis Investigative Site
Verified postcode
Clayton, Australia
Novartis Investigative Site
Verified postcode
Paris, France
Novartis Investigative Site
Verified postcode
Pessac, France
Novartis Investigative Site
Verified postcode
Strasbourg, France
Novartis Investigative Site
Verified postcode
Freiburg im Breisgau, Germany
Novartis Investigative Site
Verified postcode
Mainz, Germany
Novartis Investigative Site
Verified postcode
Barcelona, Spain
Novartis Investigative Site
Verified postcode
Madrid, Spain
Novartis Investigative Site
Verified postcode
Bern, Switzerland
Novartis Investigative Site
Verified postcode
Lausanne, Switzerland

Common questions

What is lupus?

Lupus (Systemic Lupus Erythematosus) is a condition where your immune system mistakenly attacks healthy parts of your own body, causing inflammation and damage.

What does 'severe, refractory' mean?

It means your lupus is very active and hasn't responded well to other common treatments you've tried before.

What is YTB323?

YTB323 is the name of the new medicine being tested in this study. It is an experimental treatment.

Will I know if I'm getting the study medicine?

Yes, this is an 'open-label' study, which means both you and the study doctors will know you are receiving YTB323.

Can I stop participating in the study?

Yes, you can choose to stop participating at any time, for any reason, without it affecting your future medical care.