Active — Not RecruitingPhase 2

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

Belgium, Italy, Netherlands24 participantsStarted 2024-12-11

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Diagnosis of peritonitis or need treatment of peritonitis
. Bowel perforation or evidence of obstruction
. Adenomatous colonic/rectal polyps that have not been removed
. Intestinal dysplasia
. Not undertaking appropriate surveillance, if indicated, for colorectal dysplasia/malignancy
. Family history of early onset colorectal cancer, established diagnosis of HNPCC pancolitis for \>8years duration without up-to-date colorectal cancer surveillance (can be performed during screening endoscopy if considered clinically appropriate by Investigator)
. An anti-TNF biologic within 8 weeks prior to randomization, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable.
. Any biologic targeting immune response other than an anti-TNF (including vedolizumab and ustekinumab) within 12 weeks prior to randomization unless validated therapeutic drug monitoring is performed, and drug concentrations are indetectable. Biologics not targeting immune response (eg, denosumab) will not be contraindicated.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events

Timeframe: from Week 0 to Week 12

Number of participants with abnormal Vital signs: Blood pressure

Timeframe: from Week 0 to Week 12

Number of participants with abnormal Vital signs: Pulse rate

Timeframe: from Week 0 to Week 12

Number of participants with abnormal values in haematology: complete blood count (CBC)

Timeframe: from Week 0 to Week 12

Number of participants with abnormal values in haematology: white blood cell (WBC) count

Timeframe: from Week 0 to Week 12

Number of participants with abnormal values in haematology: RBC

Timeframe: from Week 0 to Week 12

Number of participants with abnormal values in clinical chemistry: kidney function

Timeframe: from Week 0 to Week 12

Trial details

NCT IDNCT06681324

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-20

View on ClinicalTrials.gov More Crohn's Disease trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Diagnosis of peritonitis or need treatment of peritonitis
. Bowel perforation or evidence of obstruction
. Adenomatous colonic/rectal polyps that have not been removed
. Intestinal dysplasia
. Not undertaking appropriate surveillance, if indicated, for colorectal dysplasia/malignancy
. Family history of early onset colorectal cancer, established diagnosis of HNPCC pancolitis for \>8years duration without up-to-date colorectal cancer surveillance (can be performed during screening endoscopy if considered clinically appropriate by Investigator)
. An anti-TNF biologic within 8 weeks prior to randomization, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable.
. Any biologic targeting immune response other than an anti-TNF (including vedolizumab and ustekinumab) within 12 weeks prior to randomization unless validated therapeutic drug monitoring is performed, and drug concentrations are indetectable. Biologics not targeting immune response (eg, denosumab) will not be contraindicated.

What they're measuring

Number of participants with adverse events

Timeframe: from Week 0 to Week 12

Number of participants with abnormal Vital signs: Blood pressure

Timeframe: from Week 0 to Week 12

Number of participants with abnormal Vital signs: Pulse rate

Timeframe: from Week 0 to Week 12

Number of participants with abnormal values in haematology: complete blood count (CBC)

Timeframe: from Week 0 to Week 12

Number of participants with abnormal values in haematology: white blood cell (WBC) count

Timeframe: from Week 0 to Week 12

Number of participants with abnormal values in haematology: RBC

Timeframe: from Week 0 to Week 12

Number of participants with abnormal values in clinical chemistry: kidney function

Timeframe: from Week 0 to Week 12