A phase 2b, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of obefazimod in subjects with moderately to severely active Crohn’s disease

Crohn's disease

For induction and maintenance phase: change from baseline in CDAI score at Week 12 and Week 52.

For Induction and Maintenance phase: (efficacy) Change from baseline in SES-CD at Week 12 and at Week 52 respectively., For Induction phase and Maintenance phase: (efficacy) Proportion of subjects with endoscopic response at Week 12 and at Week 52 respectively., For Induction phase and Maintenance phase: (efficacy) Proportion of subjects with no SES-CD ulcer subscore > 1 in at least one segment at Week 12 and at Week 52 respectively., For Induction phase and Maintenance phase: (efficacy) Proportion of subjects with CDAI clinical remission at Week 12 and at Week 52 respectively., For Maintenance phase: (efficacy) Proportion of subjects with sustained CDAI clinical remission at Week 52., For Induction phase and Maintenance phase: (efficacy) Proportion of subjects with PRO-2 clinical remission at Week 12 and at Week 52 respectively., For Induction phase and Maintenance phase: (efficacy) Proportion of subjects with CDAI clinical response at Week 12 and at Week 52 respectively., For Induction phase and Maintenance phase: (efficacy) Proportion of subjects with PRO-2 clinical response at Week 12 and at Week 52 respectively, For Induction phase and Maintenance phase: (efficacy) Proportion of subjects with CDAI clinical response and endoscopic response at Week 12 and at Week 52 respectively, For Induction phase and Maintenance phase: (efficacy) Proportion of subjects with endoscopic remission at Week 12 and at Week 52 respectively, For Induction phase, Maintenance and Extension phase: Safety Incidence of all treatment-emergent adverse events (TEAEs), causally related TEAEs, all serious adverse events (SAE) and causally related SAEs., For Induction, Maintenance and Extension phase: Safety, Incidence of AEs leading to discontinuation, For Induction, Maintenance and Extension phase: (safety) incidence of adverse events of special interest (AESIs), For Induction, Maintenance and Extension phase: (safety) Incidence and severity of laboratory abnormalities and change from baseline in laboratory values, For Induction, Maintenance and Extension phase: PK, Obefazimod and ABX464-N-Glu plasma concentrations at baseline and at specified timepoints during Induction, Maintenance and Extension and PK parameters as determined by population PK analysis

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