This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
CDAI remission
Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight
Time frame: Week 12
Endoscopic response
Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of five defined bowel segments (rectum, sigmoid + descending colon, transverse colon, ascending colon, and terminal ileum), and in these segments the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed
Time frame: Week 12
Endoscopic remission
Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of five defined bowel segments (rectum, sigmoid + descending colon, transverse colon, ascending colon, and terminal ileum), and in these segments the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed
Time frame: Week 12
Endoscopic score change from baseline
Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of five defined bowel segments (rectum, sigmoid + descending colon, transverse colon, ascending colon, and terminal ileum), and in these segments the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed
Time frame: Week 12
CDAI response
Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight
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Research Site
Phoenix, Arizona, United States
Research Site
Escondido, California, United States
Research Site
La Jolla, California, United States
Research Site
Orlando, Florida, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Kansas City, Kansas, United States
Research Site
Clinton Township, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
Asheville, North Carolina, United States
Research Site
Charlotte, North Carolina, United States
...and 106 more locations
Time frame: Week 12
CDAI score change from baseline
Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight
Time frame: Week 12
Symptomatic remission
Decrease of average daily stool frequency and average daily abdominal pain
Time frame: Week 12
Serum AZD7798 concentration
Serum AZD7798 concentration (PK)
Time frame: Up to 85 days
Incidence of anti-drug antibody response
Incidence of anti-drug antibody (ADA) response - number and percentages with a positive ADA result
Time frame: Up to 36 weeks
Titre of anti-drug antibody response
Titre of anti-drug antibody (ADA) response - immunogenicity titre will be summarized descriptively as a continuous variable, only for ADA positive tests
Time frame: Up to 36 weeks