ACESO

Upadacitinib Co-therapy with Corticosteroids in Early Acute Severe Ulcerative Colitis (ACESO)

Study Design: A Phase III randomised placebo controlled double blinded trial
Disease Area: Inflammatory Bowel Disease (IBD)
Funder: AbbVie Ltd
Sponsor: Hull UniversityTeaching Hospitals NHS Trust
Chief Investigator: Prof. Shaji Sebastian
Trial registration: ISRCTN17100156

RECRUITING

Summary

Early addition of the rapidly acting agent Upadacitinib to conventional therapy using IV corticosteroids may reduce the need for medical rescue therapy and/or rescue surgical therapy in patients with ASUC.

What we plan to do

Primary objective

The overall study objective is to evaluate the clinical efficacy of Upadacitinib as combined treatment with intravenous steroids in patients with ASUC.

Secondary objectives

To evaluate the impact of combination therapy (Upadacitinib + steroids) on the need for rescue medical or surgical therapy
Evaluate the safety of use of combination therapy (Upadacitinib + steroids) in the setting of ASUC
Evaluate the efficacy and safety of the combination (Upadacitinib + steroids) in a subgroup of patients with prior exposure to advanced therapies
Determine the impact of combination therapy (Upadacitinib + steroids) on a range of other indices of treatment response including duration of hospital stay, time to treatment response, quality of life using CUCQ-32, patient preference using DISCUSS tool and 2 Validated psychometric tools (Decision Conflict Scale & Decision Regret Scale)
Collect biobanking samples to develop and refine high risk immunophenotype in ASUC who will benefit from combination (Upadacitinib + steroids) therapy.
Health economic assessment of treatment in ASUC

Chief Investigator

Prof Shaji Sebastian Consultant Gastroenterologist & IBD Service Lead Clinician - Hull University Teaching Hospitals NHS Trust

Co-Lead Investigators

Dr Kamal Patel Consultant Gastroenterologist - St George's University Hospitals NHS Foundation Trust
Dr Tim Raine Consultant Gastroenterologist - Cambridge University Hospitals NHS Foundation Trust

HHTU Study team

Mahboobeh Haji Sadeghi - Trial Manager
Charlotte Thompson - Trial Coordinator
Paul Bradley - Trial Coordinator
Beccy Acaster - Data Manager
Sarah Sumpter - Senior Data Manager
Kerri Morris - Trial Administrator
Bronwen Williams - Operations Manager

Collaborators

Prof Judith Cohen Director of Hull Health Trials Unit - University of Hull
Dr Chao Huang Senior Lecturer in Medical Statistics - University of Hull