Ulcerative Colitis
Conditions
Brief 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.
Interventions
DRUGEtrolizumab
Participants will receive etrolizumab at a dose of 100 mg.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to approximately Week 246 |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab | 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]) |
Secondary
| Measure | Time frame |
|---|---|
| Serum Concentrations of Etrolizumab | 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) |
Countries
Australia, Belgium, Canada, Czechia, Germany, Hungary, Israel, New Zealand, Spain, United Kingdom, United States
Outcome results
None listed