Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 4

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

NCT07258771 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 110 participants
Start Date 2026-01-16
Est. Completion 2030-12
Phase Phase 4

Sponsor

Berinstein, Jeffrey

29 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07258771 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07258771?

This trial is sponsored by Berinstein, Jeffrey, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial