An Open-Label, Investigator-Initiated Study Evaluating the Use of Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis
University of California, San Francisco
Summary
The goal of this clinical trial is to learn if the oral medication upadacitinib can safely and effectively treat acute severe ulcerative colitis (ASUC) in adults who are hospitalized. It will also evaluate whether upadacitinib can be used without corticosteroids during initial treatment. The main questions it aims to answer are: 1. Does upadacitinib reduce treatment failure by Day 14 (defined as need for colectomy or rescue therapy)? 2. What side effects and safety events occur when using upadacitinib in hospitalized patients with ASUC? Researchers will compare outcomes in participants receiving upadacitinib to a historical group of similar patients previously treated with standard therapies, including intravenous corticosteroids and infliximab, to determine if upadacitinib improves outcomes. Participants will: 1. Take oral upadacitinib once daily during hospitalization. 2. Undergo routine clinical monitoring, including blood tests and symptom assessments. 3. Be followed after discharge with clinic visits or phone calls for up to 12 months to assess outcomes such as need for additional treatment, surgery, and safety events
Description
Acute severe ulcerative colitis (ASUC) is a medical emergency associated with high morbidity and colectomy rates despite standard treatment with intravenous corticosteroids and rescue therapy with biologics such as infliximab. Limitations of current therapies include delayed onset of action, need for intravenous administration, and significant corticosteroid-related toxicity. There remains an unmet need for rapidly acting, effective, and steroid-sparing treatment strategies in the inpatient setting. Upadacitinib is an oral selective Janus kinase 1 (JAK1) inhibitor approved for the treatment o…