EU Clinical Trial 2018-002136-24

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  Feb 19, 2019

Main objective of the trial: Phase 2b Dose-Finding Induction • Assess the effect of TD-1473 taken daily for 8 weeks at daily doses of 20 mg, 80 mg, and 200 mg on the change in total Mayo score • Assess the effect of TD-1473 on rates of clinical remission, endoscopic healing, clinical response, and mucosal (ie, histologic and endoscopic) healing • Upon completion, select dose(s) of TD-1473, based on safety, tolerability, and efficacy data, including exposure-response data, for continued evaluation in the Phase 3 dose-confirming Induction Study and the Phase 3 Maintenance Study Phase 3 Dose-Confirming Induction • Assess the clinical remission rates associated with TD-1473 compared to placebo treatment at Week 8 • Assess the safety and tolerability of TD-1473 taken for up to 16 weeks Phase 3 Maintenance • Assess the clinical remission rates associated with TD-1473 compared to placebo treatment at mWeek 44 • Assess the safety and tolerability of TD-1473 with up to 44 additional weeks of treatment

Parties

Sponsors