A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative colitis is a long-term condition that causes inflammation, pain, and bleeding in the large bowel. While there are treatments available, they do not work for everyone, and symptoms can still disrupt daily life. This clinical study is testing a medicine called guselkumab for adults with moderately to severely active ulcerative colitis. Guselkumab works by targeting a specific protein in the body's immune system to help reduce gut inflammation and allow the bowel lining to heal. Researchers are comparing guselkumab against a placebo (an inactive dummy treatment) to test how well it works and check for side effects. The study is aimed at people whose previous colitis treatments did not work well or caused uncomfortable side effects. Taking part involves regular health check-ups and close monitoring by a specialist medical team.
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Ergebnisse
Ergebnisse dieser Studie
Veröffentlicht November 2024Die Ergebnisse dieser Studie wurden veröffentlicht.
Worum geht es in dieser Studie?
Ulcerative colitis is an ongoing condition where the lining of the large bowel becomes red, swollen, and ulcerated. People living with it often face sudden urges to use the toilet, diarrhoea containing blood, tummy cramps, and deep tiredness. Although many medicines can help manage flare-ups, some people find that their current treatments either stop working over time or cause unwanted side effects. Finding new ways to calm the gut is essential for long-term health.
This trial is looking at an experimental medicine called guselkumab. In people with ulcerative colitis, the immune system mistakenly attacks the lining of the bowel, driven by certain chemical signals. Guselkumab is designed to block one of these key signals, helping to dampen down inflammation so the gut can heal. In this study, some participants will receive guselkumab while others receive a placebo, which looks identical but contains no active drug.
This is a late-stage study, meaning researchers need to gather reliable evidence on how well the medicine works across a larger group of people and check its overall safety. Taking part helps scientists understand whether guselkumab could become a useful new prescription option in the UK for people struggling to keep their colitis under control.
Wichtige Erkenntnisse
- The study tests whether guselkumab can reduce gut inflammation in moderate to severe ulcerative colitis.
- It is aimed at adults whose previous colitis treatments did not work well or were hard to tolerate.
- Participants will be randomly chosen to receive either guselkumab or a dummy treatment (placebo).
- You will receive close medical monitoring and expert care throughout the study.
- Joining is entirely your choice, and you are free to leave the trial at any time.
Wer könnte berechtigt sein?
This study is open to adults aged 18 and older who have a clear diagnosis of moderate to severe ulcerative colitis. To qualify, you must have tried standard medical therapies that either did not control your symptoms well enough or caused side effects that meant you had to stop taking them. You will also need to have routine health tests, such as blood checks, to ensure taking part is safe for you.
You cannot join this study if your inflammation is only in the rectum or affects less than 20 centimetres of your bowel. It is also not suitable for people with other types of bowel inflammation, such as Crohn's disease, or anyone who currently has a stoma bag or an abnormal tunnel in the bowel wall known as a fistula. Certain medications are also not allowed during the trial.
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.
- I am aged 18 or over.
- I have a confirmed diagnosis of ulcerative colitis with active symptoms.
- My previous bowel treatments have not worked well or caused intolerable side effects.
- My inflammation spreads further than just my rectum (more than 20 cm into the bowel).
- I do not have Crohn's disease, a stoma bag, or a fistula.
Was beinhaltet die Teilnahme?
If you take part, you will first have a screening period to check your overall health and confirm that the study is safe for you. This will include blood tests, stool samples, and an examination of your bowel lining. During the trial, you will be randomly assigned to receive either guselkumab or a dummy treatment (placebo). You will need to attend hospital clinic visits for health checks, symptom reviews, and study medication doses, which may be given through a drip into a vein or as an injection under the skin. You will also be asked to keep a simple diary tracking your bowel habits. The trial typically lasts for several months up to a year, followed by a safety check-up once treatment ends.
Potenzielle Risiken und Vorteile
Locations (392)
- Om Research LLCVerifizierte PostleitzahlLancaster, United States
- UCLAVerifizierte PostleitzahlLos Angeles, Vereinigte Staaten
- Peak Gastroenterology Associates 1Verifizierte PostleitzahlColorado Springs, United States
- Florida Research Network, LLCVerifizierte PostleitzahlGainesville, Vereinigte Staaten
- University of Florida Health JacksonvilleVerifizierte PostleitzahlGainesville, Vereinigte Staaten
- Harmony Medical Research Institute, Inc.Verifizierte PostleitzahlHialeah, Vereinigte Staaten
- UF Health Jacksonville Gastroenterology EmersonVerifizierte PostleitzahlJacksonville, Vereinigte Staaten
- I.H.S. Health. LLCVerifizierte PostleitzahlKissimmee, United States
- Columbus Clinical Services LLCVerifizierte PostleitzahlMiami, Vereinigte Staaten
- Vista Health Research, LLCVerifizierte PostleitzahlMiami, Vereinigte Staaten
- Orlando HealthVerifizierte PostleitzahlOrlando, Vereinigte Staaten
- Care Access Research, OrlandoVerifizierte PostleitzahlOrlando, Vereinigte Staaten
Häufige Fragen
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active ingredients. Researchers use it to see if changes in health are truly caused by the study drug or by other factors.
Will I have to pay for the study treatment?
No. All study medications, tests, and doctor visits related to the trial are provided free of charge, and travel expenses are often covered.
Do I have to stop taking all my regular medicines?
Not necessarily, but some specific gut medicines cannot be taken alongside the study drug. The trial doctor will review all your current treatments to see what is safe.
What happens if my colitis gets worse during the trial?
Your safety comes first. If your symptoms flare up or get noticeably worse, the study team will step in and can switch you to standard medical care immediately.
Kann ich die Studie verlassen, wenn ich meine Meinung ändere?
Yes. Taking part is completely voluntary. You can withdraw at any point, and your standard NHS treatment will continue as normal.
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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