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NCT06249555 · ClinicalTrials.gov registry record
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
A clinical trial of Crohn's Disease, sponsored by Alimentiv.
- Recruiting
- Registry status
- 300
- Enrollment target
- 20
- Study locations
NCT06249555: Recruiting study of Crohn's Disease, sponsored by Alimentiv.
NCT06249555 is a study of Crohn's Disease that is actively recruiting participants, run by Alimentiv. The registered enrollment target is 300 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06249555, a study of Crohn's Disease, is actively recruiting participants, sponsored by Alimentiv.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Time to meaningful clinical improvement in pain interference, defined as a ≥ 2-point decrease in the PROMIS Pain Interference-SF T-score
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-03-20 |
| Est. Completion | 2026-12 |
What NCT06249555 shows while recruiting
NCT06249555 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (87% lower).
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.
NCT06249555 names 20 study sites across 14 states, led by Ontario, Texas, Arizona.
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.
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).
Who is sponsoring clinical trial NCT06249555?
This trial is sponsored by Alimentiv, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
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 NCT06249555's enrollment target sits among peer trials
300 37th of 105 higher than 66 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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