ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Patients and clinicians often want to know how quickly symptoms improve after starting a biologic. This study is designed to compare early patient‑reported symptom changes after starting vedolizumab versus IL‑23 antagonists, which could inform expectations about onset of benefit.
Who Should Pay Attention
Adult Crohn's disease patients starting vedolizumab or IL‑23 antagonists; gastroenterologists; IBD researchers interested in patient‑reported outcomes and biologic onset of action.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment300 participants
Study statusActive_not_recruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes an observational study (VOICE) enrolling adults with active Crohn’s disease who are starting vedolizumab or an IL‑23 antagonist (ustekinumab, risankizumab, guselkumab, or mirikizumab) as part of routine care.
The study’s main goal is to track how quickly patient‑reported symptoms—primarily pain interference measured by PROMIS—improve during the first 14 weeks after starting therapy.
The study will collect multiple PROMIS domains (pain, fatigue, anxiety, depression, sleep, physical function, social participation) and other patient‑reported outcomes, and compares the time course of response for vedolizumab versus IL‑23 antagonists.
Treatment dosing and clinical care are determined by the treating clinician; the study is observational (planned enrollment ~300).
Keep In Mind
Observational (non-randomized) design; treatments are given per routine care and dosing is not mandated by the study. The record describes planned outcomes and methods but does not contain study results.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorAlimentiv Inc.
Trial IDNCT06249555
Study typeObservational
Enrollment300 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 14, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
The study is comparing common biologics given after Crohn's surgery to prevent endoscopic recurrence—a key issue for people who have had bowel resection. Knowing which drugs perform better in real‑world practice could...
Zymfentra (Infliximab-dyyb) REal World Cohort STudy
This registry will collect one-year, patient-reported outcomes on symptom control and clinical remission while people with IBD receive Zymfentra (infliximab-dyyb) in routine care — information that may help patients and...
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
This registered Phase 2/3 program is evaluating guselkumab (an IL‑23 inhibitor) for moderate–severe Crohn's disease and could expand treatment options if trials show benefit and safety. The studies include clinical and...