An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry criteria
Ability to comply with requirements of the study, in the investigator's judgment
For women and men: use of highly effective contraception as defined by the protocol.
You may not be if
Withdrawal of consent from parent study
Discontinuation of study drug as required by the parent study protocol
Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 or from Study GA39925 prior to Week 8
Noncompliance in the parent study, specifically defined as missing scheduled visits or non-adherence with background medications and concomitant medications
Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of study drug or within 18 weeks after the final dose of study drug from GA39925, whichever is longer
Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms of infection judged by the investigator to be clinically significant since enrolling in the parent study
Use of prohibited therapies as defined in the parent study
Abnormal laboratory values, as defined in the protocol, recorded at the last visit in the parent study
Exclusion Criterion for Study Re-Entry:
Use of prohibited concomitant therapy since enrolling in the extension study
