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Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE2
NCT ID
NCT06681324
Trial Summary
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.
Sponsor: AstraZeneca
Participants: ALL
Start: 2024-12-11
Completion: 2026-08-20
Min Age: 18 Years
Max Age: 80 Years
Eligibility Criteria
Inclusion Criteria: * 18 to 80 years of age. * 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 from 5 to 25 cm (20cm length) proximal to the stoma. Participants with inflammation in additional intestinal segments are not excluded. * Capable of giving signed informed consent. Exclusion Criteria: * Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation and strictures caused by previous radiation therapy * Strictures/stenoses preventing passage of endoscope throughout the specified segment (up to 25 cm of ileum) * Short bowel syndrome * Within 3 months prior to screening: 1. Diagnosis of peritonitis or need treatment of peritonitis…
Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.