Multiple Sclerosis Clinical Trial
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
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.
Eligibility Criteria
Inclusion Criteria:
All participants (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and fulfill any of the following criteria:
Participants who have not obtained a clinical response in the Phase II study (ABS4986g) by Week 10 (the end of the Phase II treatment phase) may enter this OLE trial at any time after Week 10 and up to and including Week 28
Participants who have a clinical response in the Phase II study (ABS4986g) at Week 10 but have had a flare of UC between Week 10 and Week 28
Males and females with reproductive potential must be willing to use a highly effective method of contraception, vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half-lives)
Concomitant immunosuppressive therapy must be tapered within 6 weeks after enrollment in this OLE study
Participants must have tapered completely off oral corticosteroids within 24 weeks of enrollment to this OLE study
Exclusion Criteria:
Participants who did not complete through Week 10 of the Phase II study (ABS4986g)
Pregnancy or lactation
Any new malignancy within the past 6 months
Any new (since enrolling in the Phase II study [ABS4986g]), significant, uncontrolled, co- morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
Any new clinically significant signs or symptoms of infection as judged by the investigator
Any abnormal laboratory values recorded at the last visit completed in the Phase II study (ABS4986g)
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There are 37 Locations for this study
La Jolla California, 92037, United States
Atlanta Georgia, 30342, United States
Rochester Minnesota, 55905, United States
Great Neck New York, 11021, United States
Cincinnati Ohio, 45219, United States
Garran Australian Capital Territory, 2065, Australia
Fitzroy Victoria, 3065, Australia
Melbourne Victoria, 3004, Australia
Parkville Victoria, 3050, Australia
Bonheiden , 2820, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Vancouver British Columbia, V6Z 2, Canada
London Ontario, N6A 4, Canada
London Ontario, N6A 4, Canada
Woodbridge Ontario, L4L 4, Canada
Hradec Kralove , 500 1, Czechia
Nachod , 547 6, Czechia
Ostrava - Poruba , 708 5, Czechia
Zlin , 762 7, Czechia
Berlin , 13353, Germany
Hannover , 30625, Germany
Kiel , 24105, Germany
Minden , 32423, Germany
Ulm , 89081, Germany
Budapest , 1073, Hungary
Budapest , 1136, Hungary
Gyor , 9024, Hungary
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Jerusalem , 91031, Israel
Ramat-Gan , 52621, Israel
Tel Aviv , 64239, Israel
Auckland , , New Zealand
Christchurch , 8011, New Zealand
Dunedin , 9054, New Zealand
Takapuna , 0620, New Zealand
Barcelona , 08036, Spain
Harrow , HA1 3, United Kingdom
Newcastle upon Tyne , NE1 4, United Kingdom
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