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RECRUITING

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

NCT06249555 · View on ClinicalTrials.gov ↗

Study Summary

The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sleep disturbance, physical function, and ability to participate in social roles and activities); other PRO measures will also be assessed.

Conditions Studied

Interventions

  • DRUG Vedolizumab (VDZ)
  • DRUG Ustekinumab (UST)
  • DRUG Risankizumab (RISA)
  • DRUG Guselkumab (GUS)
  • DRUG Mirikizumab (MIR)

Study Locations (20)

Ontario

  • GNRR Digestive Clinics and Research Center — Brampton
  • London Health Sciences Centre — London
  • Alimentiv — London
  • West GTA Research Inc. — Mississauga
  • Rajbir Rai Medicine Professional Corporation — Oakville
  • ABP Research Services Corp. — Oakville

Texas

  • GI Alliance Research Fort Worth — Fort Worth
  • GI Alliance Research Mansfield — Mansfield

Arizona

  • GI Alliance - Sun City — Sun City

Florida

  • Digestive and Liver Center of Florida — Kissimmee

Illinois

  • Northwestern University — Evanston

Iowa

  • University of Iowa — Iowa City

Louisiana

  • University Medical Center New Orleans — New Orleans

Massachusetts

  • Brigham and Women's Hospital — Chestnut Hill

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2024-03-20
Est. Completion 2026-12

Sponsor

Alimentiv

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06249555

The ClinicalTrials.gov registry entry for NCT06249555 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alimentiv, which has 32 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 Crohn's Disease appearing as the primary indexed condition, and to 5 interventions — of which Vedolizumab (VDZ) 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: NCT06249555 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Ontario, Texas, Arizona. 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 NCT06249555 about?

NCT06249555 is a clinical study titled "VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study". The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sle...

What is the current status of trial NCT06249555?

This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2024-03-20. Estimated completion is 2026-12.

What conditions does trial NCT06249555 study?

This clinical trial studies the following conditions: Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06249555?

The interventions under investigation include: Vedolizumab (VDZ) (DRUG), Ustekinumab (UST) (DRUG), Risankizumab (RISA) (DRUG), Guselkumab (GUS) (DRUG), Mirikizumab (MIR) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06249555?

This trial is sponsored by Alimentiv, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06249555 being conducted?

This trial has 20 study locations across Arizona, Florida, Illinois, Iowa, Louisiana. 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