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Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis

NCT03029143 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2023-07-28

Study results available
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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.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Vedolizumab IV

Vedolizumab intravenous infusion.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2020-10-16
Completion
2020-10-16
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03029143 on ClinicalTrials.gov