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A trial to learn how safe AZD7798 is and how well it works in adults with ileal Crohn’s disease who have an ileostomy
EU CTIS ID: 2024-514407-33-00
What this study is testing
To evaluate the safety and tolerability of repeated doses of AZD7798 in the induction period
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 to 80 years of age inclusive, at the time of signing the ICF.
- 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 proximal to the stoma. Participants with inflammation in additional intestinal segments are not excluded.
You likely can't join if
- Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation, and strictures caused by previousradiation 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: -Diagnosis of peritonitis or need treatment of peritonitis -Bowel perforation or evidence of obstruction
- All intrabdominal, cutaneous and perianal/perirectal abscesses and fistulae are excluded with exception of: cutaneous and perianal/perirectal abscesses and/or fistulae which are adequately drained 4 weeks prior to randomisation, and intraabdominal fistulae between bowel segments only without complications
- Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable).
See the full eligibility criteria
Who can join
- 18 to 80 years of age inclusive, at the time of signing the ICF.
- 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 proximal to the stoma. Participants with inflammation in additional intestinal segments are not excluded.
What rules you out
- Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation, and strictures caused by previousradiation 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: -Diagnosis of peritonitis or need treatment of peritonitis -Bowel perforation or evidence of obstruction
- All intrabdominal, cutaneous and perianal/perirectal abscesses and fistulae are excluded with exception of: cutaneous and perianal/perirectal abscesses and/or fistulae which are adequately drained 4 weeks prior to randomisation, and intraabdominal fistulae between bowel segments only without complications
- Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable).
- In patients with any remaining colon and/or rectum, evidence of an increased risk of colorectal cancer, including: (a) Adenomatous colonic/rectal polyps that have not been removed (b) Intestinal dysplasia (c) Not undertaking appropriate surveillance, if indicated, for colorectal dysplasia/malignancy (d) Family history of early onset colorectal cancer, established diagnosis of HNPCC, pancolitis for > 8 years duration without up-to-date colorectal cancer surveillance (can be performed during screening endoscopy if considered clinically appropriate by Investigator).
- Reversal of ileostomy or formation of J-pouch planned prior to end of study period.
- High-output stoma (eg, > 2000 mL/24 hours) associated with volume depletion and/or electrolyte disturbance to the extent that,in the opinion of the Investigator, it may put the patient at undue risk because of participation in the study, or impact their ability to participate in the study or interfere with the interpretation of study data.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Ukraine. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.