Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
Status: | Completed |
---|---|
Conditions: | Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/16/2017 |
Start Date: | November 30, 2011 |
End Date: | August 8, 2016 |
A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis
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.
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.
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)
We found this trial at
6
sites
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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