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NCT06257706 · ClinicalTrials.gov registry record · Phase 4

VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease

A Phase 4 study of Crohn Disease and Moderately to Severely Active Crohn's Disease, sponsored by Alimentiv.

Recruiting
Registry status
Phase 4
Development phase
304
Enrollment target
20
Study locations

NCT06257706 is a Phase 4 study of Crohn Disease and Moderately to Severely Active Crohn's Disease that is actively recruiting participants, run by Alimentiv. The registered enrollment target is 304 participants, above the 201-participant average among 71 other Crohn Disease trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT06257706, a Phase 4 study of Crohn Disease and Moderately to Severely Active Crohn's Disease, is actively recruiting participants, sponsored by Alimentiv.

RECRUITING
Registry status
Phase 4
Development phase
304 participants
Enrollment target
20
Study locations

Study Summary

Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). Qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups. Group 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.

Conditions Studied

Crohn Disease Moderately to Severely Active Crohn's Disease Disease Crohn

Interventions

  • BIOLOGICAL Vedolizumab

Study Locations (20)

Victoria

  • Northern Hospital Epping - Epping
  • Austin Health - Heidelberg
  • The Alfred Hospital - Melbourne
  • Royal Melbourne Hospital - Melbourne

South Australia

  • Calvary Adelaide Hospital - Adelaide
  • Royal Adelaide Hospital - Adelaide
  • The Queen Elizabeth Hospital - Woodville

California

  • TLC Clinical Research Inc - Los Angeles - Los Angeles

South Carolina

  • Medical University of South Carolina (MUSC) - Charleston

Texas

  • Houston Methodist Hospital - Houston

New South Wales

  • Concord Repatriation General Hospital - Concord

Queensland

  • Mater Misericordiae Ltd - South Brisbane

Western Australia

  • Harry Perkins institute of Medical Research - Fiona Stanley Hospital - Murdoch

Trial Details

FieldValue
Enrollment Target 304 participants
Start Date 2024-08-07
Est. Completion 2029-02-06
Phase Phase 4

Sponsor

Alimentiv

7 total trials

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What the Registry Record Tells You About NCT06257706

The ClinicalTrials.gov registry entry for NCT06257706 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 201-participant average among 71 other Crohn Disease trials with a reported enrollment target (51% higher). The listed sponsor is Alimentiv, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Crohn Disease appearing as the primary indexed condition, and to 1 intervention - of which Vedolizumab is the first listed.

NCT06257706 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Victoria, South Australia, California.

Frequently Asked Questions

What is clinical trial NCT06257706 about?

NCT06257706 is a clinical study titled "VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease". Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a pa...

What is the current status of trial NCT06257706?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 304 participants. The study started on 2024-08-07. Estimated completion is 2029-02-06.

What conditions does trial NCT06257706 study?

This clinical trial studies the following conditions: Crohn Disease, Moderately to Severely Active Crohn's Disease, Disease Crohn.

What interventions are being tested in trial NCT06257706?

The interventions under investigation include: Vedolizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT06257706?

This trial is sponsored by Alimentiv, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06257706 being conducted?

This trial has 20 study locations across California, South Carolina, Texas, New South Wales, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.