NCT03758443

Efficacy & Safety of TD-1473 in Ulcerative Colitis

A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

Detailed description

This protocol consists of 3 separate studies: an 8-week Phase 2b dose-finding induction study, an 8-week dose-confirming Phase 3 induction study, and a 44-week Phase 3 maintenance study. Subjects who respond to induction will enter the maintenance study; those who do not will receive TD-1473 during extended induction. The safety and efficacy data of the Phase 2b study will be analyzed to select the induction and maintenance dose regimens for the confirmatory Phase 3 studies. Participants who have disease relapse or complete the maintenance study may be eligible to enter a separate long-term safety study. Efficacy, pharmacokinetic, biomarkers, and safety will be evaluated in all 3 studies. 240 subjects are planned for the Phase 2b and the planned Primary Completion Date for this portion of the study is JULY 2021. 640 subjects are planned for the Phase 3 portion of the study.

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
DRUG	Placebo	See Arm description

Timeline

• Start date: 2019-03-11
• Primary completion: 2021-10-20
• Completion: 2021-10-20
• First posted: 2018-11-29
• Last updated: 2022-11-15
• Results posted: 2022-11-15

Locations

188 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