MedTrace Logo

Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

NCT07502339 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-16

No results posted yet for this study

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

Conditions

  • UC - Ulcerative Colitis

Interventions

DRUG

Upadacitinib

Upadacitinib is an oral selective Janus kinase 1 (JAK1) inhibitor. In this study, participants will receive upadacitinib 45 mg orally once daily during hospitalization as corticosteroid-free induction therapy for acute severe ulcerative colitis. After discharge, treatment will follow protocol-defined pathways: Participants who are advanced therapy-naïve may transition to an IL-23 inhibitor after 4 weeks. Participants with prior advanced therapy exposure may continue upadacitinib 45 mg for up to 8 weeks, followed by dose reduction to standard maintenance dosing (30 mg or 15 mg once daily) at the discretion of the treating physician. Treatment duration and adjustments may vary based on clinical response and safety.

Sponsors & Collaborators

Principal Investigators

  • Sara Lewin, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-08-01
Completion
2028-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07502339 on ClinicalTrials.gov