A Participant- and Investigator-blind, Randomized, Placebo-controlled Phase II Study to Evaluate Safety, Tolerability, and Mucosal Repair With AZD7798 in Patients With Active Ileal Crohn's Disease and an Ileostomy (CALLISTO)
The purpose of this study is to evaluate safety, tolerability, and effect on mucosal repair of AZD7798 compared with placebo in participants with active ileal Crohn's disease and an ileostomy.
• 18 to 80 years of age.
• Diagnosis of Crohn's disease established with clinical, imaging, endoscopic, and/or histopathologic evidence.
• Ileostomy for at least 3 months.
• Prior to screening endoscopy, clinical suspicion of active ileal inflammation based on at least one of the following: previous endoscopy, imaging (CT, MRI, IUS), or FCP above upper reference limit.
• Active ileal Crohn's disease as determined by active intestinal mucosal inflammation, as demonstrated on video recorded ileoscopy performed during the screening period and scored by a blinded central reader with agreement on the SES CD ≥ 4 of the ileal segment proximal to the stoma. Participants with inflammation in additional intestinal segments are not excluded.
• Capable of giving signed informed consent.