Study participants
colorectal cancer, pancolitis, UC, Crohn's disease, fulminant UC, colitis
COLORECTAL CANCER, INDETERMINATE COLITIS, DISEASE, DIVERTICULOSIS, ISCHEMIC COLITIS, PANCOLITIS, RECTAL BLEEDING, CROHN'S DISEASE, MICROSCOPIC COLITIS, CHRONIC LIVER DISEASE, COLITIS
Male and female adults (18–75 years) were enrolled in the study. All patients had been diagnosed with moderate to severe UC as defined by a partial Mayo Clinic Score (MCS) ≥3 and ≤8, with stool frequency subscore ≥1, rectal bleeding subscore ≥1, and fecal calprotectin (FC) ≥150 μg/g. Patients had to have their UC diagnosis at least 12 weeks prior to screening, and the most recent colonoscopy within the last 3 years prior to screening. Those with a history of pancolitis and disease duration of ≥8 years, and those with a history of left sided colitis and disease duration ≥12 years, had to have undergone colonoscopy screening for colorectal cancer within 2 years prior to screening.Patients were excluded if they had fulminant UC, Crohn's disease, indeterminate colitis, microscopic colitis, segmental colitis associated with diverticulosis, ischemic colitis, radiation‐induced colitis, chronic liver disease or abnormal hepatic enzyme or liver function test values, history of colectomy or partial colectomy. Prohibited concomitant therapies included calcineurin inhibitors (e.g., tacrolimus, cyclosporine), vedolizumab, ustekinumab, anti‐TNFα therapeutics or any other immune system‐targeted therapy within 12 weeks or 5 half‐lives (whichever was longer) prior to screening, rectal therapy with 5‐ASA or corticosteroids within 2 weeks of screening, and leukocyte apheresis within 12 weeks of screening.