MedTrace Logo

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

NCT02611817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2022-05-25

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Conditions

Interventions

DRUG

Vedolizumab SC 108 mg

Vedolizumab SC Injection.

DRUG

Placebo

Vedolizumab placebo-matching SC injection.

DRUG

Vedolizumab IV 300 mg

Vedolizumab IV Injection.

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
2016-01-04
Primary Completion
2019-05-06
Completion
2019-08-06
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02611817 on ClinicalTrials.gov