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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Exclusion criteria
✕. Diagnosis of peritonitis or need treatment of peritonitis
✕. Bowel perforation or evidence of obstruction
✕. Adenomatous colonic/rectal polyps that have not been removed
✕. Intestinal dysplasia
✕. Not undertaking appropriate surveillance, if indicated, for colorectal dysplasia/malignancy
✕. Family history of early onset colorectal cancer, established diagnosis of HNPCC pancolitis for \>8years duration without up-to-date colorectal cancer surveillance (can be performed during screening endoscopy if considered clinically appropriate by Investigator)
✕. An anti-TNF biologic within 8 weeks prior to randomization, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable.
✕. Any biologic targeting immune response other than an anti-TNF (including vedolizumab and ustekinumab) within 12 weeks prior to randomization unless validated therapeutic drug monitoring is performed, and drug concentrations are indetectable. Biologics not targeting immune response (eg, denosumab) will not be contraindicated.
What they're measuring
1
Number of participants with adverse events
Timeframe: from Week 0 to Week 12
2
Number of participants with abnormal Vital signs: Blood pressure
Timeframe: from Week 0 to Week 12
3
Number of participants with abnormal Vital signs: Pulse rate
Timeframe: from Week 0 to Week 12
4
Number of participants with abnormal values in haematology: complete blood count (CBC)
Timeframe: from Week 0 to Week 12
5
Number of participants with abnormal values in haematology: white blood cell (WBC) count
Timeframe: from Week 0 to Week 12
6
Number of participants with abnormal values in haematology: RBC
Timeframe: from Week 0 to Week 12
7
Number of participants with abnormal values in clinical chemistry: kidney function
Timeframe: from Week 0 to Week 12
8
Number of participants with abnormal values in clinical chemistry: electrolytes