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A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors

NCT02165215 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2021-08-19

Study results available
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Summary

This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active UC who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Etrolizumab

Participants will receive 105 mg etrolizumab SC injection Q4W.

DRUG

Placebo

Participants will receive placebo (matched to etrolizumab) SC injection Q4W.

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
2014-08-12
Primary Completion
2020-04-06
Completion
2020-04-06
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Mexico
  • Poland
  • Slovakia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

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 NCT02165215 on ClinicalTrials.gov