RecruitingPhase 4NCT07258771

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

Sponsor

Berinstein, Jeffrey

Enrollment

110 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis Acute

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares adding upadacitinib (a JAK inhibitor — a type of anti-inflammatory pill) to standard steroid treatment versus steroids alone in patients hospitalized with or treated as outpatients for a severe flare of ulcerative colitis (a chronic inflammatory bowel disease). **You may be eligible if...** - You are 18 to 75 years old - You have a confirmed diagnosis of ulcerative colitis - You are having a severe flare defined as 6 or more bloody bowel movements per day plus at least one sign of systemic illness (fever, rapid heart rate, low hemoglobin, or elevated inflammation markers) **You may NOT be eligible if...** - You have previously been treated with upadacitinib - You have been on IV steroids for more than 72 hours before enrollment - You have active serious infections (including active tuberculosis or hepatitis B/C) - You have had a recent stroke, heart attack, or significant heart condition - You are pregnant or breastfeeding - You have a history of colectomy or toxic megacolon Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral Upadacitinib

Doses start at 45milligrams (mg) during acute induction and post-acute induction phase (total of 8 weeks). During the Dose Optimization Maintenance Phase, unrescued participants not undergoing colectomy will continue upadacitinib therapy through week 48, with dosage (45 mg, 30 mg, or 15 mg) titrated based on clinical symptoms and inflammatory biomarkers.

DRUGIntravenous Methylprednisolone

Intravenous (IV) given 60mg daily (in divided or full doses). Inpatients will receive this in the hospital. Outpatient participants can get this at an infusion center. Following completion of the Acute Induction Phase (inpatient cohort: 0-10 days ending at discharge; outpatient cohort: 5 days), participants will be placed on a tapering dose of prednisone.

DRUGOral Upadacitinib Placebo

The placebo will be discontinued at discharge for the inpatient cohort and after day 5 for the outpatient cohort.

DRUGOral prednisolone Taper

Following completion of the Acute Induction Phase (inpatient cohort: 0-10 days ending at discharge; outpatient cohort: 5 days), participants will be placed on a tapering dose of prednisone. Participants randomized to the corticosteroid arm will be placed on prednisone at a dose 40mg to be tapered by 5mg/week. Participants randomized to the upadacitinib and corticosteroid arm will be placed on 2 weeks of prednisone (40mg x 2 days, 30mg x 2 days, 25mg x 2 days, 20mg x 2 days, 15mg x 2 days, 10mg x 2 days, and 5mg x 2 days).

DRUGOral Prednisone - Hospital Dose Steroids

Oral Prednisone 75mg daily can be given for 5 days to participants enrolled in the Outpatient Cohort as an alternative to getting IV methylprednisolone 60mg in an infusion center. Following completion of the Acute Induction Phase, participants will be placed on a tapering dose of prednisone.

Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

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NCT07258771

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