A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis

Moderately to severely active ulcerative colitis

Co-primary endpoints: Proportion of subjects who achieve endoscopic improvement at week 8 and proportion of subjects with symptomatic remission at week 8.

Proportion of subjects who achieve clinical remission at week 8., Proportion of subjects with clinical response at week 8., Proportion of subjects with HEMI per Geboes scoring at week 8., Incidence of all treatment-emergent adverse events (TEAEs), causally related TEAEs, all serious TEAEs and causally-related serious TEAEs classified by severity., Incidence of TEAEs leading to investigational medicinal product (IMP) discontinuation and study discontinuation., Incidence of treatment-emergent adverse events of special interest (AESIs)., Incidence of clinically significant laboratory abnormalities., Incidence of clinically significant abnormalities regarding vital signs and electrocardiograms (ECGs).

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