Clinical Phase 3 Program in UC
1,200 UC patients across 36 countries will take part in the pivotal Phase 3 clinical trials that consist of two induction studies (ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106)) and a single subsequent maintenance study (ABTECT maintenance trial (ABX464-107)).
These three pivotal studies are all randomized, double-blind, and placebo controlled, using independent and central review of video-taped endoscopies. The primary efficacy endpoint, assessed at week 8 in the induction and at week 44 in the maintenance study, will be clinical remission according to the Modified Mayo Score, as recommended by the FDA.
In consultation with international regulators, including the FDA, EMA, PMDA and CDE, obefazimod 25mg and 50mg will be investigated in the ABTECT program for the treatment of UC in patients with moderately to severely active UC.
Over 600 trial sites will be participating in the studies, covering North America, Europe, Latin America and Asia Pacific.