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Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis | Clinical Trials | Clareo Health

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Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis

Acute Severe Ulcerative Colitis- Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction While Transitioning Away From the Emergency Setting (ACUTE): A Phase IV, Single Center, Partially Blinded, Randomized Study

NCT07258771•Berinstein, Jeffrey

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This study will have four phases: eligibility assessment, the acute induction phase (inpatient 0-10 days, outpatient 5 days), post-acute induction phase (end of acute induction phase to day 56 (week 8)), and maintenance phase (week 8-week 48).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient ≥ 18 to 75 years of age at the time of consent
•Diagnosis of ulcerative colitis (verified by a typical clinical history as well as characteristic appearance on endoscopy and histology)
•Meeting the following definition of acute severe ulcerative colitis as defined as having ≥ 6 bowel movements per day with visible blood in the 7 days prior to Day 0 plus at least one of the following:
•i. Temperature \> 37.8 Celsius(C) per patient report or documented in Electronic Health Record (EHR) in the 7 days prior to Day 0.
•ii. Pulse ≥ 90 beats per minute (BPM) per patient report or documented in EHR iin the 7 days prior to Day 0 iii. Hemoglobin ≤ 10.5 grams per deciliter (g/dL) in the 7 days prior to Day 0 iv. Erythrocyte sedimentation rate ≥ 30 millimeters per hour (mm/h) in the 7 days prior to Day 0 v. C-reactive protein ≥ 3.0mg/dL in the 7 days prior to Day 0 vi. Fecal calprotectin \>782 Milligrams per kilogram (mg/kg) in the 7 days prior to consent.
•vii. Oral corticosteroid use for ≥ 7 days in the month prior to consent at a dose equivalent to ≥ 20 milligrams per day (mg/day)
•For a person of reproductive/childbearing potential (i.e., presence of intact ovaries and fallopian tubes and are considered premenopausal by standard assessment), a negative lab-based (serum/urine) pregnancy test is required.
•For a person of reproductive potential (i.e., presence of intact ovaries and fallopian tubes) and has childbearing potential, intent to use at least one effective method of birth control from study Day 0 through the end of blinding or at least 30 days after the last dose of upadacitinib or week 48, whichever occurs most recently. A person without reproductive or childbearing potential does not require an intent to use effective birth control.
•Participants enrolled in the outpatient cohort must be under the care of an outpatient gastroenterologist affiliated with the University of Michigan.
•Ability to take oral medication and be willing to adhere to the study intervention regimen.
+2 more criteria

Exclusion Criteria

•On IV corticosteroids for \> 72 hours immediately prior to enrollment continuously (at any institution) which is equivalent to a cumulative dose of 180mg of IV Methylprednisolone in the 3 days prior to enrollment.
•Patients with a prior exposure upadacitinib. Previous exposure to other Janus kinase (JAK) inhibitors (e.g., tofacitinib, baricitinib, or filgotinib) are permissible.
•History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline. (Note: A Urine Drug Screen does not need to be performed).
•A history of two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster.
•Patients with ongoing severe active infection (as determined by the study team) per investigator. Patients with active serious infection(s) requiring treatment with intravenous anti-infectives or oral/intramuscular anti-infectives may consider infectious disease clearance.
•Active tuberculosis (TB) or untreated latent TB as described in the protocol.
•In participants that tested positive for Coronavirus disease 2019 (COVID-19), at least 5 days must have passed between a COVID-19 positive test result and the baseline visit of asymptomatic participants. Participants 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). Participants may be rescreened if deemed appropriate by the investigator based upon the participant's health status.
•Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery.
•Known hypersensitivity to the following drugs or constituents (and its excipients): methylprednisolone, prednisone, upadacitinib, or upadacitinib placebo. The following ingredients can be found in upadacitinib and upadacitinib placebo: colloidal silicon dioxide, hypromellose, iron oxide yellow and iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. This includes a known or suspected hypersensitivity to cow's milk for patients expected to be in the inpatient cohort (component of methylprednisolone).
•Participants that are currently pregnant or breastfeeding. Participants with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result. Participants with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test performed. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
+17 more criteria

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

January 16, 2026

Primary Completion Date

December 1, 2029

Completion Date

December 1, 2030

Last Updated

February 2, 2026

Enrollment

110

ESTIMATED participants

Conditions

Ulcerative Colitis Acute

Interventions

Oral Upadacitinib

DRUG

Intravenous Methylprednisolone

DRUG

Oral Upadacitinib Placebo

DRUG

Oral prednisolone Taper

DRUG

Oral Prednisone - Hospital Dose Steroids

DRUG

Contacts

Queen Saunyama

CONTACT

734-647-2564 saunayma@umich.edu

Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management

NCT04925973

Ulcerative Colitis Acute

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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