Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
