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An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

NCT02497469 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 771

Last updated 2020-01-28

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Vedolizumab

Vedolizumab infusion

DRUG

Adalimumab placebo

Adalimumab placebo-matching injection

DRUG

Adalimumab

Adalimumab injection

DRUG

Vedolizumab placebo

Vedolizumab placebo-matching infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2018-09-26
Completion
2019-01-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Colombia
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT02497469 on ClinicalTrials.gov