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…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * For women of childbearing potential: negative pregnancy test at screening and agreement to use acceptable contraception throughout study participation Exclusion Criteria: * • Current diagnosis of Crohn's disease, indeterminate colitis, fulminan…
Interventions
- DrugUpadacitinib
Upadacitinib 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.
Location
- UCSF Medical CenterSan Francisco, California