NCT03142321

Defining Predictors of RT Response to Vedolizumab in IBD

Completed Phase 4 Results posted Last updated 17 September 2025

What this trial tests

Phase 4 trial testing Vedolizumab 300 MG Injection [Entyvio] in Crohn Disease of Small Intestine in 48 participants. Completed in 28 October 2024.

Timeline

8 June 2018

Primary endpoint
22 May 2024

28 October 2024

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	8 June 2018
Primary completion	22 May 2024
Estimated completion	28 October 2024
Sites	1 location across United States

Drugs / interventions tested

• Vedolizumab 300 MG Injection [Entyvio] — full drug profile →

Conditions studied

• Crohn Disease of Small Intestine — all drugs for Crohn Disease of Small Intestine →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Crohn Disease of Small Intestine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Radiological Response Primary · 24±2 weeks

Radiological Transmural Response will be defined per-lesion and per-patient. Per-lesion TR will be defined as a decrease in the length of inflamed small bowel lesion from baseline or improvement in any imaging findings associated with severe mural inflammation, i.e., restricted diffusion, mural thickness, intramural T2 hyperintensity, peri-enteric T2 signal, and luminal ulcerations, without development of a new penetrating or stricturing complication. Worsened lesions will be fined as those with an increased score of any imaging parameter associated with severe mural inflammation. Unchanged le

Transmural Ulcer Healing

Group	Value	95% CI
Vedolizumab 300 MG Injection [Entyvio]	21

Transmural Remission

Group	Value	95% CI
Vedolizumab 300 MG Injection [Entyvio]	16

Radiological Response Primary · 52±2 weeks

Radiological Transmural Response will be defined per-lesion and per-patient. Per-lesion TR will be defined as a decrease in the length of inflamed small bowel lesion from baseline or improvement in any imaging findings associated with severe mural inflammation, i.e., restricted diffusion, mural thickness, intramural T2 hyperintensity, peri-enteric T2 signal, and luminal ulcerations, without development of a new penetrating or stricturing complication. Worsened lesions will be fined as those with an increased score of any imaging parameter associated with severe mural inflammation. Unchanged le

Transmural Ulcer Healing

Group	Value	95% CI
Vedolizumab 300 MG Injection [Entyvio]	12

Transmural Remission

Group	Value	95% CI
Vedolizumab 300 MG Injection [Entyvio]	9

Sponsor's own description

The overall goal of the study is to develop data that can convincingly guide clinicians on the use and efficacy of vedolizumab in patients with small bowel CD. There is an unmet need to identify response to vedolizumab in small bowel CD using objective endpoints. Current data suggest that MR enterography may meet this unmet need. There is an additional unmet need to develop predictive models incorporating both clinical and baseline radiological and endoscopic variables with higher discriminatory performance in identifying longer term clinical remission with vedolizumab. Finally, this proposal is strengthened by the exploratory studies which may identify new proteomic biomarkers that correlate with longer term radiological response with vedolizumab reflecting its latency of response. If successful, these serum biomarkers may guide a personalized approach to the treatment of small bowel CD with vedolizumab, allowing early identification of PNR, monitoring disease activity and the pharmacodynamics of vedolizumab.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.