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Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

StatusNot Yet Recruiting
PhasePhase 4
Started2026-10-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 1, 2028 → Dec 1, 2028
See other at-risk trials from University of California, San Francisco

Amendment history

2026-09-25
Primary completion pushed: 2028-08-01 → 2028-12-01
Completion pushed: 2028-08-01 → 2028-12-01
2026-04-13
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v1
Sponsor changed: Sara Lewin, MD → University of California, San Francisco+25 characters
WasSara Lewin, MD
NowUniversity of California, San Francisco
Completion moved earlier: 2028-12-01 → 2028-08-01
Study title-66 characters
An Open-Label, Investigator-Initiated Study Evaluating the Use of Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis
2026-03-25
Original filing
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
Trial Details
NCT Number NCT07502339
Lead Sponsor University of California, San Francisco
Collaborators: AbbVie
Conditions UC - Ulcerative Colitis
Enrollment 50 participants
Start Date 2026-10-15
Primary Completion 2028-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-24