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NCT07258771 · ClinicalTrials.gov registry record · Phase 4
Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis
A Phase 4 study of Ulcerative Colitis Acute, sponsored by Berinstein, Jeffrey.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT07258771: Recruiting Phase 4 study of Ulcerative Colitis Acute, sponsored by Berinstein, Jeffrey.
NCT07258771 is a Phase 4 study of Ulcerative Colitis Acute that is actively recruiting participants, run by Berinstein, Jeffrey. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07258771, a Phase 4 study of Ulcerative Colitis Acute, is actively recruiting participants, sponsored by Berinstein, Jeffrey.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Initial Clinical Response Definition: * A reduction in liquid bowel movements per 24 hours by ≥ 60% from randomization AND a C-reactive protein (CRP) \< 1.5 milligrams per deciliter (mg/dL) AND no more than trace blood in stool, or * 4 liquid bowel movements or less per 24 hours AND a C-reactive protein (CRP) \< 1.5 mg/dL AND no more than trace blood in stool. Liquid bowel movements are defined as completely liquid (Bristol stool chart type 7) or mostly liquid (Bristol stool chart type 8). If
Conditions Studied
Interventions
- DRUG Intravenous Methylprednisolone
- DRUG Oral Upadacitinib
- DRUG Oral Upadacitinib Placebo
- DRUG Oral prednisolone Taper
- DRUG Oral Prednisone - Hospital Dose Steroids
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2026-01-16 |
| Est. Completion | 2030-12 |
| Phase | Phase 4 |
What NCT07258771 shows while recruiting
NCT07258771 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Ulcerative Colitis Acute appearing as the primary indexed condition, and to 5 interventions - of which Intravenous Methylprednisolone is the first listed.
NCT07258771 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT07258771 about?
NCT07258771 is a clinical study titled "Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis". 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...
What is the current status of trial NCT07258771?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2026-01-16. Estimated completion is 2030-12.
What conditions does trial NCT07258771 study?
This clinical trial studies the following conditions: Ulcerative Colitis Acute.
What interventions are being tested in trial NCT07258771?
The interventions under investigation include: Intravenous Methylprednisolone (DRUG), Oral Upadacitinib (DRUG), Oral Upadacitinib Placebo (DRUG), Oral prednisolone Taper (DRUG), Oral Prednisone - Hospital Dose Steroids (DRUG).
Who is sponsoring clinical trial NCT07258771?
This trial is sponsored by Berinstein, Jeffrey, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07258771 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07258771's enrollment target sits among peer trials
110 727th of 2000 higher than 1,265 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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