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NCT05369832 · ClinicalTrials.gov registry record · Phase 4

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

A Phase 4 study, sponsored by Bristol-Myers Squibb.

Terminated
Registry status
Phase 4
Development phase
139
Enrollment target

NCT05369832: Clinical Trial Phase 4 study, sponsored by Bristol-Myers Squibb.

NCT05369832 is a Phase 4 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 139 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05369832, a Phase 4 study, was terminated before completion, sponsored by Bristol-Myers Squibb.

TERMINATED
Registry status
Phase 4
Development phase
139 participants
Enrollment target

Study Summary

The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.

Primary Outcome

Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score: * Decrease from baseline ≥ 2 points, * Decrease from baseline ≥ 35%, * Decrease from baseline in the Rectal Bleeding (RB) subscore ≥ 1 point or absolute RB subscore ≤ 1 The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components: * Stool Frequency (SF): scored 0-3 (higher score = more frequent stools), * Rectal Blee

Interventions

  • DRUG Ozanimod

Trial Details

FieldValue
Enrollment Target 139 participants
Start Date 2022-12-16
Est. Completion 2025-04-11
Phase Phase 4
Bristol-Myers Squibb

1,025 total trials

Why NCT05369832 stopped before completion

NCT05369832 is an interventional study that assigns participants to a tested intervention. The registered 139 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 (73% lower).

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

NCT05369832 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05369832 about?

NCT05369832 is a clinical study titled "An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice". The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.

What is the current status of trial NCT05369832?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 139 participants. The study started on 2022-12-16. Estimated completion is 2025-04-11.

What interventions are being tested in trial NCT05369832?

The interventions under investigation include: Ozanimod (DRUG).

Who is sponsoring clinical trial NCT05369832?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05369832's enrollment target sits among peer trials

139 593rd of 2000 higher than 1,408 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 NCT05369832, the US trial registry maintained by the National Library of Medicine. NCT05369832 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.