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

Research summary

The study will be a pragmatic,Phase IIIb,two-arm,double-blind randomised (1:1) placebo-controlled trial of ASUC patients admitted to UK National Health Service (NHS) hospitals. The study will recruit 300 patients admitted to hospital with suspected ASUC over ~30 months across up to 30 UK sites. Participant involvement in the study will depend on their response to IMP or placebo treatment. Screening,baseline assessment and randomisation will take place within 36 hours from the first dose of IV corticosteroids. The initial blinded IMP or placebo treatment period will be up to Day 10 at which point all participants will be unblinded. Clinical response or maintenance treatment will continue until the end of the 8-week maintenance treatment period. There is a 12-month routine clinical care visit for observational data collection. In addition,SAEs will be reported up to 30 days after the last dose of IMP of placebo. Data collection and analysis of participant outcomes following study participation may continue for up to 5 years using data linkage via NHS England,or devolved nation equivalent,without any additional burden to the participant.

Principal Investigator

Dr Alissa Walsh

Contact us

Email: ctf.research@ouh.nhs.uk

IRAS number

1010109