Etrolizumab
DrugParticipants will receive etrolizumab at a dose of 100 mg.
NCT Number: NCT01461317
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
The Canberra Hospital, Garran, Australian Capital Territory, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive etrolizumab at a dose of 100 mg.
Time frame: Baseline up to approximately Week 246
Time frame: Baseline up to approximately Week 246 (assessed at predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to Week 252, 12 weeks after last dose [up to approximately Week 246])
Time frame: Predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to approximately Week 246; 12 weeks after last dose (up to approximately Week 246)
Genentech, Inc.
Industry
A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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