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
Male or female ≥18 and ≤75 years of age hospitalized with ASUC (Mayo score >10 or Truelove and Witts criteria)
Diagnosis of UC for at least 90 days, confirmed by colonoscopy; appropriate documentation of biopsy results consistent with the diagnosis of UC
No prior use of upadacitinib
Capable of providing informed consent
• Current diagnosis of Crohn's disease, indeterminate colitis, fulminant colitis, and/or toxic megacolon
Disease limited to the rectum during screening endoscopy
History of colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or was planning bowel surgery
Infections requiring treatment with IV anti-infectives within 30 days before baseline or oral anti-infectives within 14 days before baseline
Single group
Upadacitinib
DrugUpadacitinib is an oral selective Janus kinase 1 (JAK1) inhibitor. In this study, participants will receive upadacitinib 45 mg orally once daily during hospitalization as corticosteroid-free induction therapy for acute severe ulcerative colitis. After discharge, treatment will follow protocol-defined pathways: Participants who are advanced therapy-naïve may transition to an IL-23 inhibitor after 4 weeks. Participants with prior advanced therapy exposure may continue upadacitinib 45 mg for up to 8 weeks, followed by dose reduction to standard maintenance dosing (30 mg or 15 mg once daily) at the discretion of the treating physician. Treatment duration and adjustments may vary based on clinical response and safety.
Treatment Failure
Proportion of participants experiencing treatment failure by Day 14. Treatment failure is defined as the occurrence of any of the following: Colectomy (total or subtotal colectomy performed for ulcerative colitis), need for rescue therapy with intravenous corticosteroids, or need for rescue therapy with intravenous infliximab
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University of California, San Francisco
Lead sponsor
AbbVie
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
