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Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis

NCT01461317 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2020-02-10

No results posted yet for this study

Summary

This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.

Conditions

Interventions

DRUG

Etrolizumab

Participants will receive etrolizumab at a dose of 100 mg.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-11-29
Primary Completion
2016-08-07
Completion
2016-08-07

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Israel
  • New Zealand
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01461317 on ClinicalTrials.gov