Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease

Ulcerative Colitis Clinical Trial

Official title: A Randomized, Open Label Phase 2 Study to Assess Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Exploratory Efficacy of Vedolizumab Subcutaneous Compared to Vedolizumab Intravenous in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to assess the bioavailability and pharmacokinetics (PK) of multiple doses of vedolizumab subcutaneous (SC) compared to vedolizumab intravenous (IV).

Clinical Trial Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to determine its availability and reaction in the body of people who have moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD). This study will look at the availability and reaction of vedolizumab in people who are administered the treatment subcutaneously (SC) compared people who are administered the treatment intravenously (IV).

The study will enroll approximately 200 patients with moderately to severely active UC or CD. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups:

• vedolizumab 300 mg IV

• vedolizumab 300 mg IV and vedolizumab 160 mg SC

• vedolizumab 300 mg IV and vedolizumab 108 mg SC

• vedolizumab 480 mg SC and vedolizumab 160 mg SC

• vedolizumab 324 mg SC and vedolizumab 108 mg SC

All participants will receive one of the treatments they are assigned to at various treatment visits throughout the study.

This multi-centre trial will be conducted in North America, Europe and Asia. The overall time to participate in this study is approximately 41 weeks in addition to a follow-up survey that will be administered every 6 months for 2 years. Participants will make 16 visits to the clinic, including a safety follow-up assessment 18 weeks after last dose of study drug. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

• NCT number: NCT02913508
• Study type: Interventional
• Source: Takeda
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2014
• Completion date: December 2015