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Attivo ma non reclutanteFASE2, FASE3INTERVENTISTICO

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.

A colpo d'occhio

Stato
Attivo ma non reclutante
Fase
FASE2, FASE3
Sponsor
Janssen Ricerca & Sviluppo, LLC
Obiettivo di iscrizione
1,064
Inizio
26 Sep 2019
Completamento stimato
16 Lug 2027

Risultati

Risultati di questo studio

Pubblicato November 2024

I risultati di questo studio sono stati pubblicati.

Risultato principale
Induction Study 1: Percentage of Participants With Clinical Response at Week I-12
Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.
Risultati completi nel registro

Di cosa tratta questo studio?

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.

Punti chiave

  • 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.

Chi può essere idoneo?

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.

Questo studio potrebbe fare al caso tuo?

Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.

  1. I am aged 18 or over.
  2. I have a confirmed diagnosis of ulcerative colitis with active symptoms.
  3. My previous bowel treatments have not worked well or caused intolerable side effects.
  4. My inflammation spreads further than just my rectum (more than 20 cm into the bowel).
  5. I do not have Crohn's disease, a stoma bag, or a fistula.
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

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.

Rischi e benefici potenziali

The possible benefit of joining is that the study medicine may help calm your bowel inflammation and ease your symptoms, though this cannot be guaranteed. You will also receive frequent, detailed health monitoring from bowel specialists. The main risks include side effects from the study drug, such as mild injection site reactions, headaches, or a slightly higher risk of common infections like colds. Because this is a controlled trial, you might also receive the placebo rather than the active medicine. You are free to leave the study at any time without giving a reason, and your normal NHS care will not be affected.

Locations (392)

  • Om Research LLC
    Codice postale verificato
    Lancaster, United States
  • UCLA
    Codice postale verificato
    Los Angeles, Stati Uniti
  • Peak Gastroenterology Associates 1
    Codice postale verificato
    Colorado Springs, Stati Uniti
  • Florida Research Network, LLC
    Codice postale verificato
    Gainesville, Stati Uniti
  • University of Florida Health Jacksonville
    Codice postale verificato
    Gainesville, Stati Uniti
  • Harmony Medical Research Institute, Inc.
    Codice postale verificato
    Hialeah, United States
  • UF Health Jacksonville Gastroenterology Emerson
    Codice postale verificato
    Jacksonville, Stati Uniti
  • I.H.S. Health. LLC
    Codice postale verificato
    Kissimmee, United States
  • Columbus Clinical Services LLC
    Codice postale verificato
    Miami, Stati Uniti
  • Vista Health Research, LLC
    Codice postale verificato
    Miami, Stati Uniti
  • Orlando Health
    Codice postale verificato
    Orlando, Stati Uniti
  • Care Access Research, Orlando
    Codice postale verificato
    Orlando, Stati Uniti

Domande comuni

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.

Posso abbandonare lo studio se cambio idea?

Yes. Taking part is completely voluntary. You can withdraw at any point, and your standard NHS treatment will continue as normal.

Come saperne di più

Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.

Discussione

Discussione della comunità

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