A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
The ROSETTA study is investigating a new medication called Rosnilimab for adults in the UK who have moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the lining of the large intestine. This study will compare Rosnilimab with a placebo (a dummy treatment without active medicine) to understand if it helps improve the condition and if it causes any side effects. It's a phase 2 study, meaning it's still in the earlier stages of testing and aims to get a better understanding of the treatment's safety and how well it works before it could potentially be used more widely.
Auf einen Blick
Worum geht es in dieser Studie?
Ulcerative colitis is a type of inflammatory bowel disease where the lining of the large intestine (colon) becomes inflamed and develops small sores, or ulcers. This can lead to symptoms like tummy pain, diarrhoea, and needing to go to the toilet urgently. For many people, existing treatments can help manage these symptoms, but for others, their condition remains moderate to severe, meaning their symptoms significantly affect their daily life.
This study, called ROSETTA, is exploring Rosnilimab, a new potential treatment for moderate to severe ulcerative colitis. The main goal is to find out if Rosnilimab can reduce inflammation and improve symptoms more effectively than a placebo, which looks exactly like the study medicine but contains no active drug. By comparing Rosnilimab to a placebo, doctors can learn more about its true effects. The study will also carefully monitor any side effects to understand how safe the treatment is.
This is a 'Phase 2' study, which means it builds on earlier research. In this phase, a larger group of people will receive the treatment, allowing researchers to get a clearer picture of its effectiveness and safety. Understanding these aspects is crucial before a new treatment can move forward into even larger studies and potentially become available as a standard treatment for people with ulcerative colitis.
Wichtige Erkenntnisse
- Investigating Rosnilimab, a new potential treatment for moderate to severe ulcerative colitis.
- Compares Rosnilimab to a placebo (dummy treatment) to assess effectiveness and safety.
- Open to adults aged 18 and over in the UK.
- Designed for people whose ulcerative colitis hasn't responded well to at least two other known treatments.
- Participation involves regular clinic visits for assessments and taking study medication.
- Sie können jederzeit von der Studie zurücktreten.
Wer könnte berechtigt sein?
To join this study, you would need to be an adult (age 18 or older) with a confirmed diagnosis of ulcerative colitis. Your condition must be considered moderate to severe, and you should have already tried at least two different types of ulcerative colitis medications in the past that either didn't work well enough, stopped working, or caused side effects that you couldn't tolerate.
There are also some reasons why you wouldn't be able to join. For example, if your doctor has diagnosed you with Crohn's disease instead of ulcerative colitis, or if your ulcerative colitis is limited just to the rectum (the very end of the large intestine). You also wouldn't be able to take part if you've had major bowel surgery like removing part or all of your colon. The study is also not suitable if you've already tried three or more advanced types of ulcerative colitis treatments (like certain biologic therapies or JAK inhibitors) that didn't help.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Sind Sie 18 Jahre alt oder älter?
- Do you have a diagnosis of moderate to severe ulcerative colitis?
- Have you tried at least two different types of ulcerative colitis medications that didn't work well enough, stopped working, or caused side effects?
- Have you NOT been diagnosed with Crohn's disease?
- Have you NOT had major bowel surgery for your ulcerative colitis?
- Have you NOT tried three or more advanced types of ulcerative colitis treatments that didn't help?
Was beinhaltet die Teilnahme?
If you decide to take part in this study, you'll be randomly assigned to receive either the new study medicine, Rosnilimab, or a placebo (a dummy treatment). Neither you nor your study doctor will know which one you're receiving, which helps ensure the results are unbiased. You would attend regular appointments at the study clinic for assessments, which might include physical exams, blood tests, and potentially endoscopies (where a small camera is used to look inside your colon). You'd take the study medication as instructed, and the study team would carefully monitor your health and any changes in your symptoms. The full duration of your participation, including follow-up, would be fully explained by the study team.
Potenzielle Risiken und Vorteile
Standorte (100)
- AnaptysBio Investigational Site 10-115Verifizierte PostleitzahlPhoenix, Vereinigte Staaten
- AnaptysBio Investigational Site 10-117Verifizierte PostleitzahlGarden Grove, United States
- AnaptysBio Investigational Site 10-112Verifizierte PostleitzahlLancaster, United States
- AnaptysBio Investigational Site 10-129Verifizierte PostleitzahlLancaster, United States
- AnaptysBio Investigational Site 10-108Verifizierte PostleitzahlSan Jose, Vereinigte Staaten
- AnaptysBio Investigational Site 10-127Verifizierte PostleitzahlBrooksville, United States
- AnaptysBio Investigational Site 10-106Verifizierte PostleitzahlMiami, Vereinigte Staaten
- AnaptysBio Investigational Site 10-109Verifizierte PostleitzahlMiami Gardens, United States
- AnaptysBio Investigational Site 10-131Verifizierte PostleitzahlOrlando, Vereinigte Staaten
- AnaptysBio Investigational Site 10-123Verifizierte PostleitzahlOrlando, Vereinigte Staaten
- AnaptysBio Investigational Site 10-125Verifizierte PostleitzahlTampa, Vereinigte Staaten
- AnaptysBio Investigational Site 10-122Verifizierte PostleitzahlAtlanta, Vereinigte Staaten
Häufige Fragen
Was ist Colitis ulcerosa?
It's a long-term condition causing inflammation and ulcers in the lining of your large intestine (colon), leading to symptoms like tummy pain and frequent diarrhoea.
What does 'Phase 2 study' mean?
It means the treatment is still in earlier stages of testing, looking at its safety and how well it works in a larger group of people after initial safety checks.
Was ist ein Placebo?
A placebo is a dummy treatment that looks like the study medication but contains no active drug. It helps researchers compare the new treatment's effects accurately.
Will I know if I'm getting Rosnilimab or the placebo?
No, neither you nor your study doctor will know, which helps make sure the study results are fair and reliable. This is called 'double-blind'.
Kann ich die Studie verlassen, wenn ich meine Meinung ändere?
Yes, your participation is completely voluntary, and you can withdraw from the study at any time without it affecting your standard medical care.
Wie Sie mehr erfahren können
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
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