Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

Stopped early · Phase 3

Conditions studied: Ulcerative Colitis

In brief

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 \[NCT01461317\]) or the Phase III studies (GA28948 \[NCT02163759\], GA28949 \[NCT02171429\], GA28950 \[NCT02100696\], GA29102 \[NCT02165215\], and GA29103 \[NCT02136069\]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.

Key facts

Study ID

NCT02118584

Run by

Hoffmann-La Roche

People needed

1822

Starts

2014-09-15

Expected to finish

2023-10-05

Last updated by the study team

2024-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part 1 (Open-label Extension)
• Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol
• Part 2 (Safety Monitoring)
• Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
• Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
• Participants who transfer from Part 1 (OLE)
• Completion of the 12-week safety follow-up prior to entering.

You may not qualify if…

• Part 1 (Open-label Extension)
• Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
• Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
• Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
• Any new, significant, uncontrolled condition

Where it is running

• University of California San Diego Medical Center — La Jolla, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• SDG Clinical Research — San Diego, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Clinical Research of the Rockies — Lafayette, Colorado, United States
• Rocky Mountain Gastroenterology Associates — Wheat Ridge, Colorado, United States
• Innovative Medical Research of South Florida, Inc. — Aventura, Florida, United States
• West Central Gastroenterology d/b/a Gastro Florida — Clearwater, Florida, United States
• Regenerate Clinical Trials — Miami, Florida, United States
• IMIC, Inc — Miami Beach, Florida, United States
• FQL Research, LLC — Miramar, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Advanced Research Institute, Inc. — New Port Richey, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Atlanta Gastroenterology Specialists, PC — Suwanee, Georgia, United States
• Northwestern University Feinberg School Of Medicine — Chicago, Illinois, United States
• University of Chicago Medical Center; Medicine, Section of Pulmonary — Chicago, Illinois, United States
• Southwest Gastroenterology — Oak Lawn, Illinois, United States
• University of Alabama Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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