ClinicaliQ Trial Snapshot
- Study Evaluating AZD7798 for Treatment in Crohn’s Disease Patients With an Ileostomy — Recruiting • Phase II • Rheumatology • NCT06681324.
- 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.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.