3 results
The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…
Primary:The primary objective of this study is to evaluate the efficacy of LDX administered as a daily morning dose (30, 50, and 70mg/day) compared to placebo over the course of 7 weeks. This study will enrol children and adolescents (6-17 years of…
The primary objective of this study is to evaluate the safety and tolerability using bleeding as the primary endpoint. Secondarily, this study will serve as a proof-of concept by evaluating the effect that DS-1040b administration has on total…