NCT06681324

Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy

A Participant- and Investigator-blind, Randomized, 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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a participant-and investigator-blind, randomized, parallel-group, placebo controlled phase II study designed to evaluate safety, tolerability, and mucosal repair with AZD7798 in participants with active ileal Crohn's disease and an ileostomy. This study will include a screening period, an induction period, an open-label maintenance period, and a follow-up period. Approximately 30 participants will be randomized globally to receive either AZD7798 or placebo during 12-week participant- and investigator- blind induction period. At week 12 after induction period, all eligible participants will enter 40-week open label maintenance period. Follow-up visits will take place 8 weeks and 18 weeks after the last dose of study intervention, whether this occurs during the induction period or the open-label maintenance period.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	AZD7798	AZD7798
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-12-11
• Primary completion: 2026-08-20
• Completion: 2027-09-03
• First posted: 2024-11-08
• Last updated: 2026-03-16

Locations

22 sites across 7 countries: Belgium, Italy, Netherlands, Poland, Sweden, Ukraine, United Kingdom