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

NCT07258771 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

  • Ulcerative Colitis Acute

Interventions

DRUG

Oral 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.

DRUG

Intravenous 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.

DRUG

Oral Upadacitinib Placebo

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

DRUG

Oral 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).

DRUG

Oral 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.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Berinstein, Jeffrey

    lead OTHER

Principal Investigators

  • Jeffrey Berinstein, MD, MSc · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07258771 on ClinicalTrials.gov