Actively Recruiting
Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis
Led by Berinstein, Jeffrey · Updated on 2026-02-02
110
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
B
Berinstein, Jeffrey
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial is being conducted to learn more about the optimal sequence of various medications in the management of acute severe ulcerative colitis (ASUC). This research is studying multiple drugs already approved by the Food and Drug Administration (FDA). The goal of this study is to test the early efficacy and safety of upadacitinib (Rinvoq) and corticosteroids compared to corticosteroids alone as induction therapy for both inpatients and outpatients with ASUC.
CONDITIONS
Official Title
Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of consent
- Diagnosis of ulcerative colitis confirmed by typical clinical history, endoscopy, and histology
- Acute severe ulcerative colitis defined by having 6 or more bowel movements per day with visible blood in the 7 days before study start plus at least one symptom such as fever, high pulse, low hemoglobin, high inflammation markers, or recent corticosteroid use
- Negative pregnancy test for those who can become pregnant
- Use of effective birth control during the study if of childbearing potential
- Outpatient participants must be under care of a University of Michigan gastroenterologist
- Ability to take oral medication and follow study procedures
- Willingness to comply with visits, tests, surveys, and treatment
- Signed informed consent indicating understanding of the study
You will not qualify if you...
- Use of intravenous corticosteroids for more than 72 hours before enrollment
- Prior use of upadacitinib
- History of significant drug or alcohol abuse in the past 6 months
- History of multiple or disseminated herpes zoster infections
- Ongoing severe active infection
- Active or untreated latent tuberculosis
- Recent COVID-19 infection without resolved symptoms or required waiting period
- Recent serious cardiovascular events within past 6 months
- Known allergy to study drugs or their ingredients
- Pregnancy or breastfeeding
- Recent live vaccine use or planned live vaccination during the study
- Diagnosis of toxic megacolon
- Active cytomegalovirus colitis unless treated and approved
- Recent use of investigational agents or participation in other interventional studies
- Active malignancy except certain skin or cervical cancers
- History of major bowel surgery or planned surgery excluding partial colectomy
- Significant kidney, blood, liver, or gastrointestinal impairment
- Liver cirrhosis
- Conditions predisposing to blood clotting except controlled cases
- Active hepatitis B or C infection without proper management
- Advanced HIV infection
- Recent or planned organ transplant
- History or high risk of gastrointestinal perforation
- Current use or anticipated use of strong CYP3A4 inducers or inhibitors including grapefruit
- Conditions affecting oral drug absorption such as certain stomach surgeries
- Significant medical conditions as defined by study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
Q
Queen Saunyama
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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