Phase 4
Completed N=278
Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT03029143 ↗
Enrolled (actual)
278
Serious AEs
4.0%
Results posted
Nov 2021
Primary outcomePrimary: Percentage of Participants Achieving Mucosal Healing at Week 30 — 18.9; 14.5 percentage of participants — p==0.401
◆ Published Evidence
Established
25citations · ~13 / year
ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse.
Summary
The purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in participants with moderately to severely active ulcerative colitis (UC) and high vedolizumab clearance, based on a Week 5 predefined serum vedolizumab concentration threshold less than (<) 50 microgram per milliliter (microg/mL) and who are Week 6 non-responders based on partial Mayo score.
Linked Publications
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ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Mucosal Healing at Week 30 |
18.9; 14.5 | =0.401 |
| SECONDARY Percentage of Participants Achieving Clinical Remission at Week 30 |
9.4; 9.1 | =0.943 |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 30 |
32.1; 30.9 | =0.893 |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 14 |
34.0; 40.0 | =0.525 |
| SECONDARY Percentage of Participants Achieving Corticosteroid-Free Remission |
21.4; 14.3 | =0.623 |
| SECONDARY Percentage of Participants Achieving Durable Clinical Response |
22.6; 30.9 | =0.344 |
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis of UC established at least 1 month prior to Screening by clinical and endoscopic evidence and corroborated by a histopathology report.
- Has moderately to severely active UC as determined by a complete Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 28 days prior to enrollment.
- Has evidence of UC proximal to the rectum (≥15 cm of involved colon) prior to start of vedolizumab IV dosing.
- Has been determined to be suitable for vedolizumab IV for routine management of UC by their physician.
- Has a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening).
- Has demonstrated an inadequate response with, lost response to, or intolerance of at least 1 of the following agents: immunomodulators, corticosteroids, or tumor necrosis factor-alpha (TNF-α) antagonists. Subject who are naive to TNF-α antagonist therapy or who have previously failed TNF-α antagonist therapy (including primary and secondary non-responders or intolerant) may be included.
Week 6 Randomized Treatment Period Inclusion Criteria
- Following Lead-in Period, the subject is assessed as having high vedolizumab drug clearance based on a predefined Week 5 serum vedolizumab concentration threshold ( 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case by-case basis prior to Screening.
- Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease.
- Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during Screening or prior to the administration of the first dose of study drug on Day 1.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit.
Data sourced from ClinicalTrials.gov (NCT03029143) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.