NCT03635112

Efficacy and Safety of TD-1473 in Crohn's Disease

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo˗Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.

Detailed description

A Phase 2 multi-center, randomized, double blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 12 weeks of induction therapy with TD˗1473 in subjects with moderately-to-severely active Crohn's Disease. This study includes 3 phases: Screening, Induction, and Active Treatment Extension (ATE). The Induction phase of the study is a randomized, double blind, placebo controlled, parallel group study evaluating 2 oral dose levels of TD-1473 compared to placebo for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 in the ATE, for up to 48 additional weeks.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Placebo	Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.
DRUG	TD-1473	TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.

Timeline

• Start date: 2018-11-19
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2018-08-17
• Last updated: 2023-03-13
• Results posted: 2023-03-13

Locations

178 sites across 22 countries: United States, Australia, Austria, Bulgaria, Croatia, France, Georgia, Germany, Greece, Hungary, Israel, New Zealand, Poland, Portugal, Romania, Russia, Serbia, South Africa, South Korea, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study