A trial to learn how safe AZD7798 is and how well it works in adults with ileal Crohn’s disease who have an ileostomy

Trial details

Who runs it

AstraZeneca AB

Trial code

EU 2024-514407-33-00

Record updated

2026. október 21.

Original description

To evaluate the safety and tolerability of repeated doses of AZD7798 in the induction periodRead full original descriptionShow less

A Participant- and Investigator-blind, Randomised, 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)

To evaluate the safety and tolerability of repeated doses of AZD7798 in the induction period

Inclusion: 18 to 80 years of age inclusive, at the time of signing the ICF; Diagnosis of Crohn’s disease established with clinical, AND at least one of imaging, endoscopic, and/or histopathologic evidence; Ileostomy (including Kock pouch) 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.

Exclusion: Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation, and strictures caused by previousradiation therapy; Within 3 months prior to screening: -Diagnosis of peritonitis or need treatment of peritonitis -Bowel perforation or evidence of obstruction; All intrabdominal, cutaneous and perianal/perirectal abscesses and fistulae are excluded with exception of: cutaneous and perianal/perirectal abscesses and/or fistulae which are adequately drained 4 weeks prior to randomisation, and intraabdominal fistulae between bowel segments only without complications; Reversal of ileostomy or formation of J-pouch planned prior to end of study period; Short bowel syndrome; In patients with any remaining colon and/or rectum, evidence of an increased risk of colorectal cancer, including: (a) Adenomatous colonic/rectal polyps that have not been removed (b) Intestinal dysplasia (c) Not undertaking appropriate surveillance, if indicated, for colorectal dysplasia/malignancy (d) Family history of early onset colorectal cancer, established diagnosis of HNPCC, pancolitis for > 8 years duration without up-to-date colorectal cancer surveillance (can be performed during screening endoscopy if considered clinically appropriate by Investigator); Strictures/stenoses preventing passage of endoscope throughout the specified segment (up to 25 cm of ileum); Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable); High-output stoma (eg, > 2000 mL/24 hours) associated with volume depletion and/or electrolyte disturbance to the extent that,in the opinion of the Investigator, it may put the patient at undue risk because of participation in the study, or impact their ability to participate in the study or interfere with the interpretation of study data.

EU CTIS 2024-514407-33-00