A Phase 1/2a Study of REGN7041 (anti-CD3 monoclonal antibody) in patients with Active Noninfectious Uveitis affecting the Posterior Segment
This study is about a new medicine called REGN7041 for people who have swelling and irritation in their eye, known as non-infectious uveitis. This type of uveitis isn't caused by germs. This is one of the first times this medicine has been given to people. The main goal is to check how safe it is and if it causes any unwanted effects. Researchers will also look at how the medicine moves through the body and if the body makes antibodies against it. This information helps us understand the medicine better before it can be studied in larger groups of people. It’s for adults aged 18 and over, both men and women.
At a glance
What is this study about?
This study is looking into a new treatment called REGN7041 for an eye condition called non-infectious uveitis. Uveitis means there's swelling and irritation inside your eye. In this particular type, the swelling isn't caused by an infection, which means antibiotics or antifungals won't help. This condition can affect different parts of the eye, and this study focuses on uveitis that impacts the back of the eye, known as the posterior segment.
REGN7041 is a type of medicine called a monoclonal antibody, which is designed to target specific things in the body. In this case, it's aimed at helping to reduce the inflammation in the eye. This is a very early-stage study, meaning it’s one of the first times this new medicine is being given to people. The main purpose at this stage is to carefully check how safe it is and if people experience any side effects. Researchers will be paying close attention to any changes in your health after receiving the treatment.
Understanding how safe a new medicine is crucial before it can be used more widely. Besides safety, the study will also look at how much of the medicine is in the blood over time and if the body’s immune system creates responses against it. This helps doctors understand how the medicine works in the body. If the medicine proves safe and shows promise, it can then be studied in larger groups of people to see how well it actually treats the uveitis.
Key takeaways
- This study is for a new medicine called REGN7041 for non-infectious uveitis.
- It's an early-stage study primarily focused on checking the safety of the medicine.
- Participants must be adults (18+) with active non-infectious uveitis affecting the back of the eye.
- Regular clinic visits, blood tests, and eye exams will be part of the study.
- Participation is voluntary, and you can withdraw at any time.
- Potential benefits and risks will be discussed in full detail by the study team.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
You must have active non-infectious uveitis affecting the back part of your eye. This means your eye condition is currently inflamed and not caused by an infection. The study will have specific medical criteria that your doctor will check to make sure you're a good fit for this particular research.
There will also be other health requirements and conditions that might prevent you from joining, such as other serious medical problems or previous treatments. Your study doctor will explain all these details to you to confirm if you meet all the necessary requirements 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 18 years old or older?
- Do you have swelling and irritation in your eye (uveitis)?
- Is your uveitis 'non-infectious' (not caused by germs)?
- Does your uveitis affect the back part of your eye?
- Are you able to attend regular clinic appointments for the study?
What does participation involve?
If you decide to join this study, you will receive the new medicine, REGN7041. This is a "Phase 1/2a" study, meaning it's an early step where researchers are primarily focused on safety. You would have regular visits to the study clinic for check-ups, where doctors and nurses will monitor your health very closely. They will look for any side effects and check how you are responding to the medicine.
During these visits, you can expect to have blood tests to measure the medicine's levels and see if your body developed any antibodies against it. You'll also have eye exams and other medical assessments to track your uveitis and general health. The doctors and nurses will explain all the procedures and tests to you in detail.
The total length of time you'd be involved in the study, including follow-up visits after you've finished receiving the medicine, would be explained to you before you agree to take part. The exact number of visits and their timing would be provided in the full study information.
Potential risks and benefits
Locations (1)
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Common questions
What is non-infectious uveitis?
It's a condition where there's swelling and irritation inside your eye, but it's not caused by germs like bacteria or viruses.
What is REGN7041?
It's a new investigational medicine being tested to see if it can help with non-infectious uveitis.
What does 'Phase 1/2a' mean for this study?
It means this is a very early stage where researchers are mainly checking if the new medicine is safe and what side effects it might have when given to people for the first time.
Will this medicine cure my uveitis?
It's too early to say if it will cure or significantly help your uveitis. The main goal of this study is to understand its safety.
Can I stop being part of the study once I've started?
Yes, you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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