A Phase 4 interventional study of Vedolizumab 300 MG Injection [Entyvio] in Crohn Disease of Small Intestine, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 48 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vedolizumab will be initiated at 300 mg intravenous (IV) dosing at 0, 2 and 6 weeks followed by the 1st maintenance with 300 mg IV at week 14. Patients who have not achieved clinical response at week 14 will be eligible to undergo dose escalation to 4 weekly dosing of vedolizumab depending on the judgement of the treating gastroenterologist.
Drug: Vedolizumab 300 MG Injection [Entyvio]
Vedolizumab Injection
Also known as: Entyvio
Radiological Response
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 lesions will be defined as those with unchanged (without worsening or improving) inflammatory parameters associated with severe mural inflammation. Patients will be then classified for TR as responders if all individual lesions improved and non-responders if any of the lesions worsened, a new lesion developed at the 4 month MRE and all other scenarios not meeting definition of response.
Time frame: 24±2 weeks
Radiological Response
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 lesions will be defined as those with unchanged (without worsening or improving) inflammatory parameters associated with severe mural inflammation. Patients will be then classified for TR as responders if all individual lesions improved and non-responders if any of the lesions worsened, a new lesion developed at the 4 month MRE and all other scenarios not meeting definition of response.
Time frame: 52±2 weeks
| Milestone | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| Started | 48 |
| Week 14 dose escalation to every 4 weeks | 2 |
| Completed | 22 |
| Not completed | 26 |
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 lesions will be defined as those with unchanged (without worsening or improving) inflammatory parameters associated with severe mural inflammation. Patients will be then classified for TR as responders if all individual lesions improved and non-responders if any of the lesions worsened, a new lesion developed at the 4 month MRE and all other scenarios not meeting definition of response.
| participants | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| Transmural Ulcer Healing | 21 |
| Transmural Remission | 16 |
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 lesions will be defined as those with unchanged (without worsening or improving) inflammatory parameters associated with severe mural inflammation. Patients will be then classified for TR as responders if all individual lesions improved and non-responders if any of the lesions worsened, a new lesion developed at the 4 month MRE and all other scenarios not meeting definition of response.
| participants | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| Transmural Ulcer Healing | 12 |
| Transmural Remission | 9 |
Collected over Over the course of the participants time in the study, which was 1 year.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vedolizumab 300 MG Injection [Entyvio] Every 8 Weeks | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Vedolizumab 300 MG Injection [Entyvio] Every 4 Weeks (Dose Escalation) After Week 14 | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 48 |
| >=65 years | 0 |
| Age, Continuous(years) | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| Median | 33.95 (27.45 to 47.22) |
| Sex: Female, Male(Participants) | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| Female | 26 |
| Male | 22 |
| Race (NIH/OMB)(Participants) | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 7 |
| White | 38 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| United States | 48 |
| Montreal Location(participants) | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| L1 - terminal ileum | 8 |
| L3 - ileocolonic | 40 |
| Montreal Behavior(Participants) | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| B1 non-stricturing, non-penetrating | 22 |
| B1p non-stricturing, non-penetrating with perianal disease | 3 |
| B2 stricturing | 8 |
| B2p stricturing with perianal disease | 1 |
| B3 penetrating | 7 |
| B3p penetrating with perianal disease | 7 |
| Montreal Age Classification(Participants) | Vedolizumab 300 MG Injection [Entyvio] |
|---|---|
| 1 - Age of diagnosis at 16 years or younger | 6 |
| 2 - Age of diagnosis at 17-40 years | 32 |
| 3 - Age of diagnosis at >40 years | 10 |
11 further baseline measures are reported on the registry.
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