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Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

NCT02611830 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2022-05-25

Study results available
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Summary

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Vedolizumab 300 mg IV

Vedolizumab intravenous infusion

DRUG

Placebo IV

Vedolizumab intravenous infusion placebo

DRUG

Vedolizumab 108 mg SC

Vedolizumab subcutaneous injection

DRUG

Placebo SC

Vedolizumab subcutaneous injection placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-18
Primary Completion
2018-05-30
Completion
2018-08-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT02611830 on ClinicalTrials.gov