A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD)
This important study is testing a new medication, rozanolixizumab, for adults living with Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD). MOGAD is a rare condition that affects the brain and spinal cord. We're trying to find out if this new medicine is effective at reducing symptoms or preventing new flare-ups, and if it's safe for people to use. Participants will receive either the new medicine or a dummy treatment (placebo) to help us understand its true effects. This research aims to offer new treatment options for those affected by MOGAD.
At a glance
What is this study about?
This study is all about a condition called MOGAD, which stands for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease. MOGAD is a rare illness where the body's immune system mistakenly attacks healthy cells in the brain, spinal cord, and optic nerves, which can cause flare-ups with various symptoms like vision problems or weakness. We're looking at a new medicine called rozanolixizumab to see if it can help adults with this condition.
The main goal is to find out if rozanolixizumab is effective in treating MOGAD. This means we want to see if it can make symptoms better, reduce the number of flare-ups, or even prevent them. We also need to check if the medicine is safe and if people can tolerate taking it without too many side effects. To do this, some people in the study will receive the new medicine, while others will receive a 'placebo' – this looks just like the real medicine but contains no active ingredients. This helps scientists truly understand if the medicine is making a difference.
This kind of study, called a 'Phase 3' study, is usually one of the final steps before a new medicine might become widely available. It's really important because it helps us understand if the new treatment offers a better option for people living with MOGAD. Finding effective and safe treatments is crucial for improving the lives of those affected by rare conditions like MOGAD.
Key takeaways
- Tests a new medicine for MOGAD called rozanolixizumab.
- Aims to see if the medicine is safe and helps reduce flare-ups or symptoms.
- Compares the new medicine with a dummy treatment (placebo).
- For adults aged 18-89 with a confirmed MOGAD diagnosis.
- You might get either the active medicine or the placebo.
- Your participation helps advance MOGAD research.
Who may be eligible?
To join this study, you need to be an adult, aged between 18 and 89 years old. You must have a clear diagnosis of MOGAD that your doctor has confirmed.
You should also have had at least one MOGAD flare-up in the last year, and a recent blood test (within the last six months) showing that you have MOG antibodies. When you start the study, your MOGAD symptoms should be stable, meaning you're not having an active flare-up.
There are also some reasons why you might not be able to join. For example, if you have other autoimmune conditions like MS or certain types of NMOSD, or if you have a significant infection. You also wouldn't be able to participate if you've been diagnosed with problems with your immune system, or if your blood test shows very low levels of certain antibodies (called IgG).
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 an adult aged 18 to 89?
- Do you have a confirmed MOGAD diagnosis?
- Have you had at least one MOGAD flare-up in the last year?
- Was your MOG antibody blood test positive in the last 6 months?
- Are your MOGAD symptoms stable right now (not in an active flare-up)?
- Do you have any other serious autoimmune conditions or active infections?
What does participation involve?
If you decide to take part in this study, you'll be given either the new study medicine, rozanolixizumab, or a placebo (a dummy treatment). You won't know which one you're receiving. You'll need to attend regular appointments at the study clinic for check-ups, blood tests, and to assess your MOGAD symptoms and overall health. These visits will help the doctors see how you are responding to the treatment and keep an eye on any side effects.
The study involves several visits over a period of time, and you'll have ongoing support from the study team. They will explain everything in detail, including how often you need to visit and what each visit will involve, including any medication you need to take at home. After the treatment period, there will be a follow-up period to continue monitoring your health.
Potential risks and benefits
Locations (55)
- Mog001 50297Verified postcodeScottsdale, United States
- Mog001 50450Verified postcodePalo Alto, United States
- Mog001 50101Verified postcodeAurora, United States
- Mog001 50553Verified postcodeWashington D.C., United States
- Mog001 50308Verified postcodeTampa, United States
- Mog001 50472Verified postcodePeoria, United States
- Mog001 50552Verified postcodeBaltimore, United States
- Mog001 50243Verified postcodeBoston, United States
- Mog001 50104Verified postcodeRochester, United States
- Mog001 50568Verified postcodeSan Antonio, United States
- Mog001 50473Verified postcodeSalt Lake City, United States
- Mog001 30022Verified postcodeMelbourne, Australia
Common questions
What is MOGAD?
MOGAD is a rare condition where your body's immune system mistakenly attacks certain healthy cells in your brain, spinal cord, and optic nerves, leading to flare-ups.
What is rozanolixizumab?
It's a new medicine being tested to see if it can help adults with MOGAD by possibly reducing symptoms or flare-ups.
Will I get the real medicine or a dummy treatment?
In this study, you might receive either the active medicine (rozanolixizumab) or a placebo (a dummy treatment). You and your doctors won't know which one you're getting.
How long will the study last?
The study involves a period of treatment, followed by follow-up appointments. The study team will tell you the exact duration.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.
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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