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Last Updated: September 28, 2022

CLINICAL TRIALS PROFILE FOR ETROLIZUMAB


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Clinical Trials for Etrolizumab

Trial ID Title Status Sponsor Phase Summary
NCT01461317 ↗ Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis Completed Genentech, Inc. Phase 2 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.
NCT02100696 ↗ A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors Completed Hoffmann-La Roche Phase 3 This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.
NCT02118584 ↗ Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies Active, not recruiting Hoffmann-La Roche Phase 3 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.
NCT02136069 ↗ 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 Completed Hoffmann-La Roche Phase 3 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.
NCT02163759 ↗ A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors Completed Hoffmann-La Roche Phase 3 This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.
NCT02165215 ↗ 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 Completed Hoffmann-La Roche Phase 3 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.
NCT02171429 ↗ A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors Completed Hoffmann-La Roche Phase 3 This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naIve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28948; NCT02163759) was independently conducted.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Etrolizumab

Condition Name

Condition Name for
Intervention Trials
Ulcerative Colitis 8
Crohn Disease 2
Crohn's Disease 1
Healthy Volunteer 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Colitis 8
Ulcer 8
Colitis, Ulcerative 8
Crohn Disease 3
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Clinical Trial Locations for Etrolizumab

Trials by Country

Trials by Country for
Location Trials
United States 199
Brazil 53
Italy 45
Australia 36
Ukraine 36
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Trials by US State

Trials by US State for
Location Trials
California 10
Texas 10
Michigan 8
Georgia 8
Florida 8
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Clinical Trial Progress for Etrolizumab

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 8
Phase 2 1
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 9
Active, not recruiting 2
Recruiting 1
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Clinical Trial Sponsors for Etrolizumab

Sponsor Name

Sponsor Name for
Sponsor Trials
Hoffmann-La Roche 9
Genentech, Inc. 3
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 12
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