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A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

NCT02136069 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2021-12-03

Study results available
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Summary

This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous \[IV\] infusion at Weeks 0, 2, and 6, then once every 8 weeks \[Q8W\]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.

Conditions

Interventions

DRUG

Etrolizumab

105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.

DRUG

Infliximab

5 mg/kg of infliximab will be administered by intravenous (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.

OTHER

Placebo (IV)

Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.

OTHER

Placebo (Injection)

Administered by SC injection Q4W until Week 52

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-24
Primary Completion
2020-06-23
Completion
2020-06-23
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Portugal
  • Romania
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • 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 NCT02136069 on ClinicalTrials.gov