drugset / Trial / NCT02818686

TD-1473 for Active Ulcerative Colitis (UC)

NCT02818686 ↗

Phase 1 Completed 40 enrolled Theravance Biopharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.

Timeline

Start
2016-10-03
Primary completion
2018-03-29
Completion
2018-03-29

Drugs

EvaluationDrugModalityDoseRoute
Subject IZENCITINIB Small molecule 20 mg Oral
Subject IZENCITINIB Small molecule 80 mg Oral
Subject IZENCITINIB Small molecule 270 mg Oral

Indications