A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)
A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)
A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157
This is a multi-center, long-term safety study to evaluate the safety and tolerability of TD-1473 for up to 156 weeks (3 years) + 4 week follow-up in subjects with moderate to severe UC exiting the preceding Maintenance Study of Protocol 0157 (NCT03758443).
Inclusion Criteria:
To be eligible for the study, subjects are required to enter the LTS Study within 14 days of exiting the Maintenance Study of Protocol 0157 and must meet all the following criteria:
Capable of providing informed consent, which must be obtained prior to any study related procedures.
One of the following:
During the study and for 7 days after receiving the last dose of the study drug, females of childbearing potential or men capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly)) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at Day 1
All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
Must be able and willing to adhere to the study visit schedule and comply with other study requirements.
Exclusion Criteria:
Sofia, Sofia 1303, Bulgaria
Sofia, Sofia 1527, Bulgaria
Sofia, Sofia 1784, Bulgaria
Patra, Peloponnese 265 04, Greece
Ageo Shi, Saitama 362-0075, Japan