Une étude sur l'Obexelimab chez les patients atteints de sclérose en plaques récurrente (MoonStone)
The MoonStone study is testing a new medicine called obexelimab for people living with relapsing multiple sclerosis (MS). MS is a long-term condition affecting the brain and spinal cord, causing a wide range of symptoms. This study wants to find out how well obexelimab works and if it's safe to use. For the first 12 weeks, some participants will receive obexelimab, while others will get a placebo (a dummy treatment). After this, for the next 12 weeks, everyone will receive obexelimab. Following this, participants will continue to receive obexelimab for a longer period. This research is important to potentially offer new treatment options for people with relapsing MS, aiming to reduce relapses and improve quality of life.
En un coup d'œil
De quoi parle cette étude ?
This study, called MoonStone, is looking into a new medicine known as obexelimab for people who have relapsing multiple sclerosis (MS). Relapsing MS is a type of MS where you have periods of new or worsening symptoms (relapses) followed by periods of recovery. The main goal of this study is to see if obexelimab is effective at managing MS and if it's safe for people to use.
For the first part of the study, lasting 12 weeks, some participants will receive obexelimab, while others will be given a placebo. A placebo is a treatment that looks just like the real medicine but contains no active drug. This helps researchers understand if any improvements are due to obexelimab itself. After these 12 weeks, everyone in the study will receive obexelimab for a further 12 weeks, and then for an even longer period of about a year.
Finding new and effective treatments for MS is really important. Studies like MoonStone help doctors and researchers understand how new medicines work, their potential benefits, and any side effects. This research could ultimately lead to more options for people with relapsing MS, helping to manage their condition and improve their daily lives.
Points clés
- MoonStone is a study for people with relapsing multiple sclerosis.
- It's testing a new medicine called obexelimab.
- Participants will receive weekly injections, either obexelimab or a placebo at first, then all obexelimab.
- The study lasts about 1 year and 9 months, including regular clinic visits.
- It's about finding new and safer ways to treat MS.
Qui peut être éligible ?
To join this study, you need to be an adult between 18 and 60 years old and have been diagnosed with a type of MS called relapsing MS (this includes relapsing-remitting MS or secondary progressive MS with relapses).
Your MS should show some signs of recent activity. This means you would have had at least one relapse in the last year, or two relapses in the last two years, or have shown recent signs of MS activity on a brain scan (MRI) within the last six months. Also, your MS should not be too severe, meaning your disability score (known as EDSS) should be 5.5 or less.
There are also some reasons why you might not be able to join. For example, if you have primary progressive MS or secondary progressive MS without relapses, or if you have a different condition called neuromyelitis optica spectrum disorder. If you've had a relapse very recently (within the last 30 days) or have a very large number of active lesions on your MRI scan, you also wouldn't be able to take part.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Are you between 18 and 60 years old?
- Do you have a diagnosis of relapsing MS (relapsing-remitting or secondary progressive with relapses)?
- Have you had at least one relapse in the last year, two in the last two years, or an active lesion on a recent MRI scan?
- Is your disability from MS not too severe (EDSS score 5.5 or less)?
- Do you not have primary progressive MS or secondary progressive MS without relapses?
En quoi consiste la participation ?
If you decide to take part in the study, it will involve several stages over about 92 weeks (approximately 1 year and 9 months). First, there's a screening period to check if the study is right for you.
For the first 12 weeks, you'll receive weekly injections under the skin (like a small jab) of either obexelimab or a placebo. You won't know which one you're getting. After this, for the next 12 weeks, every participant will receive weekly injections of obexelimab. Following these 24 weeks, you'll continue to receive obexelimab for about a year.
Throughout the study, you'll have regular visits to the clinic for check-ups, assessments, and to receive your medication. There will also be a follow-up period after your last dose of medicine to monitor your health. You may need to visit the clinic more often during this follow-up if special blood tests haven't returned to normal levels. The study team will explain everything in detail if you are interested.
Risques et avantages potentiels
Locations (47)
- North Central NeurologyCode postal vérifiéCullman, États-Unis
- Center for Neurology and SpineCode postal vérifiéPhoenix, États-Unis
- Perseverance Research CenterCode postal vérifiéScottsdale, États-Unis
- Regina Berkovich MD PhD, IncCode postal vérifiéWest Hollywood, United States
- Aqualine Clinical ResearchCode postal vérifiéNaples, États-Unis
- University of South FloridaCode postal vérifiéTampa, États-Unis
- University of Massachusetts Medical SchoolCode postal vérifiéWorcester, United States
- Infusion Associates PlymouthCode postal vérifiéPlymouth, United States
- MS Center for Innovations in CareCode postal vérifiéSaint Louis, États-Unis
- Holy Name Medical CenterCode postal vérifiéTeaneck, United States
- Boster Center for MSCode postal vérifiéColumbus, États-Unis
- North Texas Institute of Neurology and HeadacheCode postal vérifiéPlano, United States
Questions fréquentes
What is multiple sclerosis (MS)?
MS is a long-term condition that affects your brain and spinal cord, which can lead to problems with vision, balance, movement, and sensation. Relapsing MS means symptoms come and go.
What is obexelimab?
Obexelimab is a new medicine being tested in this study to see if it can help people with relapsing MS.
Qu'est-ce qu'un placebo ?
A placebo is a 'dummy' treatment that looks like the real medicine but doesn't contain any active drug. It helps researchers compare the new medicine's effects.
Comment le médicament sera-t-il administré ?
The medicine (obexelimab or placebo) will be given as a weekly injection under the skin.
Combien de temps durera l'étude ?
The study is expected to last for about 92 weeks, which is roughly 1 year and 9 months.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Discussion
Discussion communautaire
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