Upadacitinib for Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Sara Lewin, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral upadacitinib 45 mg once daily during hospitalization as corticosteroid-free induction therapy
Follow-up
Participants are monitored for safety and effectiveness after discharge, with clinic visits or phone calls for up to 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Upadacitinib
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants hospitalized with acute severe ulcerative colitis will receive oral upadacitinib 45 mg once daily as corticosteroid-free induction therapy during hospitalization, followed by protocol-defined post-discharge management and longitudinal follow-up through 52 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
AbbVie
Industry Sponsor
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