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NCT05867329 · ClinicalTrials.gov registry record · Phase 4

Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis

A Phase 4 study of Ulcerative Colitis Acute, sponsored by Berinstein, Jeffrey.

Recruiting
Registry status
Phase 4
Development phase
162
Enrollment target
1
Study location

NCT05867329: Recruiting Phase 4 study of Ulcerative Colitis Acute, sponsored by Berinstein, Jeffrey.

NCT05867329 is a Phase 4 study of Ulcerative Colitis Acute that is actively recruiting participants, run by Berinstein, Jeffrey. The registered enrollment target is 162 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05867329, a Phase 4 study of Ulcerative Colitis Acute, is actively recruiting participants, sponsored by Berinstein, Jeffrey.

RECRUITING
Registry status
Phase 4
Development phase
162 participants
Enrollment target
1
Study location

Study Summary

The goal of this trial is to create personalized treatments for each patient admitted to the hospital with acute severe ulcerative colitis (ASUC). The study will test the feasibility and acceptability of these treatment strategies among patients and physicians so that the study team can later do a larger trial to test whether the medication treatment pathways help patients avoid colectomy while ensuring patient's are safe.

Primary Outcome

Target ≥60%

Conditions Studied

Interventions

  • DRUG Cyclosporine Injection (IV)
  • DRUG Cyclosporine Oral Product
  • DRUG Upadacitinib Extended Release Oral Tablet
  • DRUG Intravenous Methylprednisolone
  • DRUG Prednisone Oral Product

Study Locations (1)

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2023-09-30
Est. Completion 2026-05
Phase Phase 4
Berinstein, Jeffrey

2 total trials

What NCT05867329 shows while recruiting

NCT05867329 is an interventional study that assigns participants to a tested intervention. The registered 162 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 (69% lower).

The record links to 1 condition, with Ulcerative Colitis Acute appearing as the primary indexed condition, and to 5 interventions - of which Cyclosporine Injection (IV) is the first listed.

NCT05867329 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT05867329 about?

NCT05867329 is a clinical study titled "Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis". The goal of this trial is to create personalized treatments for each patient admitted to the hospital with acute severe ulcerative colitis (ASUC). The study will test the feasibility and acceptability of these treatment strategies among patients and physicians so that the study team can later do a l...

What is the current status of trial NCT05867329?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 162 participants. The study started on 2023-09-30. Estimated completion is 2026-05.

What conditions does trial NCT05867329 study?

This clinical trial studies the following conditions: Ulcerative Colitis Acute.

What interventions are being tested in trial NCT05867329?

The interventions under investigation include: Cyclosporine Injection (IV) (DRUG), Cyclosporine Oral Product (DRUG), Upadacitinib Extended Release Oral Tablet (DRUG), Intravenous Methylprednisolone (DRUG), Prednisone Oral Product (DRUG).

Who is sponsoring clinical trial NCT05867329?

This trial is sponsored by Berinstein, Jeffrey, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05867329 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Ulcerative Colitis Acute

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05867329's enrollment target sits among peer trials

162 503rd of 2000 higher than 1,496 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 NCT05867329, the US trial registry maintained by the National Library of Medicine. NCT05867329 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.