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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07258771
The ClinicalTrials.gov registry entry for NCT07258771 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Berinstein, Jeffrey, which has 2 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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