Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

Starting soon · Phase 4

Conditions studied: UC - Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT07502339

Run by

University of California, San Francisco

People needed

50

Starts

2026-07-01

Expected to finish

2028-08-01

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• • 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
• Contraindication to IL-23 agent if advanced therapy-naïve
• Known hypersensitivity to upadacitinib or any excipients
• History of lymphoproliferative disorder, lymphoma, leukemia, or any malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ
• History of venous thromboembolic event (DVT, PE) within past 12 months
• Any condition that, in the investigator's opinion, would compromise the participant's safety or study outcomes
• History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline.
• Meeting any of the following conditions at Baseline:
• Two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
• One or more prior episodes of disseminated herpes simplex (including eczema herpeticum);
• Human immunodeficiency virus (HIV) infection, defined as confirmed positive anti-HIV antibody (HIV Ab) test or a positive HIV Ab/Ag test
• Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual);
• Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;
• Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study;
• COVID-19 infection: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status.
• HBV and HCV screening values that meet the following criteria at the most recent testing prior to the first dose of study drug :
• HBV: hepatitis B surface antigen (HBs Ag) positive (+) test or detectable HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for subjects who are hepatitis B core antibody (HBc Ab) positive (+)
• HCV: detectable HCV ribonucleic acid (RNA) in any subject with anti-HCV antibody (HCV Ab).
• At Baseline any of the following medical diseases or disorders:
• Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, (note: include the following only for new protocols) aorto-coronary bypass surgery, or venous thromboembolism;
• History of an organ transplant which requires continued immunosuppression;
• History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;

Where it is running

• UCSF Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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