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NCT07502339 · ClinicalTrials.gov registry record · Phase 4

Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

A Phase 4 study, sponsored by University of California, San Francisco.

Not yet
Registry status
Phase 4
Development phase
50
Enrollment target

NCT07502339: Clinical Trial Phase 4 study, sponsored by University of California, San Francisco.

NCT07502339 is a Phase 4 study that has not yet begun recruiting, run by University of California, San Francisco. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07502339, a Phase 4 study, has not yet begun recruiting, sponsored by University of California, San Francisco.

NOT YET RECRUITING
Registry status
Phase 4
Development phase
50 participants
Enrollment target

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

Primary Outcome

Proportion of participants experiencing treatment failure by Day 14. Treatment failure is defined as the occurrence of any of the following: Colectomy (total or subtotal colectomy performed for ulcerative colitis), need for rescue therapy with intravenous corticosteroids, or need for rescue therapy with intravenous infliximab

Interventions

  • DRUG Upadacitinib

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2026-07-01
Est. Completion 2028-08-01
Phase Phase 4

What is known before NCT07502339 opens enrollment

NCT07502339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which Upadacitinib is the first listed.

NCT07502339 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07502339 about?

NCT07502339 is a clinical study titled "Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis". 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 q...

What is the current status of trial NCT07502339?

This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2026-07-01. Estimated completion is 2028-08-01.

What interventions are being tested in trial NCT07502339?

The interventions under investigation include: Upadacitinib (DRUG).

Who is sponsoring clinical trial NCT07502339?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07502339's enrollment target sits among peer trials

50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07502339, the US trial registry maintained by the National Library of Medicine. NCT07502339 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.