RecruitingPhase 2NCT06681324

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)


Sponsor

AstraZeneca

Enrollment

30 participants

Start Date

Dec 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug (AZD7798) applied directly into the intestine through an ileostomy (a surgical opening on the abdomen) in people with active Crohn's disease affecting the small intestine. The goal is to reduce intestinal inflammation with fewer whole-body side effects. **You may be eligible if...** - You are between 18 and 80 years old - You have a confirmed diagnosis of Crohn's disease with active inflammation in your small intestine - You have had an ileostomy for at least 3 months - A recent scope of your small intestine confirms active disease **You may NOT be eligible if...** - Your Crohn's disease involves only the large intestine (colon) - You have had recent bowel surgery or major complications - You have serious infections or significant other health conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD7798

AZD7798

OTHERPlacebo

Placebo


Locations(22)

Research Site

Leuven, Belgium

Research Site

Padova, Italy

Research Site

Roma, Italy

Research Site

Rozzano, Italy

Research Site

Amsterdam, Netherlands

Research Site

Nijmegen, Netherlands

Research Site

Lodz, Poland

Research Site

Poznan, Poland

Research Site

Poznan, Poland

Research Site

Warsaw, Poland

Research Site

Wroclaw, Poland

Research Site

Gothenburg, Sweden

Research Site

Linköping, Sweden

Research Site

Stockholm, Sweden

Research Site

Kyiv, Ukraine

Research Site

Kyiv, Ukraine

Research Site

Vinnytsia, Ukraine

Research Site

Birmingham, United Kingdom

Research Site

Cambridge, United Kingdom

Research Site

London, United Kingdom

Research Site

London, United Kingdom

Research Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

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Visit

NCT06681324


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