Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis (NCT07502339) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis
United States50 participantsStarted 2026-07-01
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, 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 significa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment Failure
Timeframe: 14 Days
Trial details
NCT IDNCT07502339
SponsorUniversity of California, San Francisco
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-08-01
Contact for this trial
UCSF Crohn's and Colitis Center Research Coordinator Team