NCT03920254

TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

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)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
DRUG	TD-1473 Dose A	See Arm description
DRUG	TD-1473 Dose B	See Arm description
DRUG	TD-1473 Dose C	See Arm description

Timeline

• Start date: 2020-07-23
• Primary completion: 2021-10-27
• Completion: 2021-10-27
• First posted: 2019-04-18
• Last updated: 2022-11-02
• Results posted: 2022-11-02

Locations

184 sites across 22 countries: United States, Australia, Bulgaria, Canada, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study