Clinical Trial

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

Study acronym: VOICE
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
critical Enrollment closed, study ongoing 2026-08-15
notable Primary completion pushed: 2026-06 -> 2026-09 2026-08-15
Trial Details
NCT Number NCT06249555
Lead Sponsor Alimentiv Inc.
Collaborators: Takeda
Conditions Crohn's Disease
Enrollment 300 participants
Start Date 2024-03-20
Primary Completion 2026-09 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-14