19-082 - Efficacy & Safety of TD-1473 in Ulcerative Colitis

Status: open

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

Treatment for inflammatory bowel disease

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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.

Providers Associated With This Trial

Principle Investigator

  • Jack Di PalmaView Profile
    Jack A. Di Palma, M.D.GastroenterologistProgram Director of Division of Gastroenterology; Director of Section of Inflammatory Bowel Diseases; Professor of Internal Medicine

Sub Investigators

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