ACESO

  • Research type

    Research Study

  • Full title

    ACESO trial: Upadacitinib Co-therapy with Corticosteroids in Early Acute Severe Ulcerative Colitis (A Phase III randomised placebo controlled double blinded trial)

  • IRAS ID

    1010109

  • Contact name

    Sebastian Shaji

  • Contact email

    shaji.sebastian4@nhs.net

  • Sponsor organisation

    Hull University Teaching Hospital NHS Trust

  • ISRCTN Number

    ISRCTN17100156

  • Research summary

    Ulcerative colitis (UC) is a condition in which the large intestine, also known as the colon, becomes inflamed. In most patients, UC involves some periods when well but also periods where the symptoms become more severe (called flares).
    Sometimes, the intensity of UC symptoms means patients need to be admitted to hospital. If this happens, patients will be given drugs called corticosteroids (commonly known as steroids) to control and reduce the inflammation. If steroids on their own work, patients can be discharged from hospital, usually after just a few days. However, if the steroids are not making the symptoms better, other medicines can be given to try to help. This would normally be either a drug called Infliximab or Ciclosporin. Either drug can be used and both are equally effective but the improvements with these drugs only occurs in some patients. If these additional treatments do not work, then is some cases, surgery to remove the colon would be considered. This is called a colectomy.
    Currently, we know that only half of patients given steroids alone will get better, whilst the other half will need one of the other medications and some patients will still need to have surgery.
    This study will test whether giving patients another medicine, Upadacitinib which is approved for use in UC, in addition to the standard initial treatment with steroids, will reduce the number of patients who go on to receive further medical treatments or need surgery.
    This randomised controlled trial will recruit 300 adults who have been admitted to UK NHS hospitals with an Acute Severe flare of UC (ASUC) . The study has a double blind active/placebo medication period when the patient and clinical team wont know which additional treatment but after 10 days all participants will know what they have been taking. Depending on the response to study medication/placebo, participants may be in the study for up to 8 weeks.

  • REC name

    West of Scotland REC 1

  • REC reference

    24/WS/0123

  • Date of REC Opinion

    17 Oct 2024

  • REC opinion

    Further Information Favourable Opinion