AZD7798 for Crohn's disease|Active ileal Crohn's disease with ileostomy

Inclusion criteria

• {"criterion_text":"- 18 to 80 years of age inclusive, at the time of signing the ICF."}
• {"criterion_text":"- Diagnosis of Crohn’s disease established with clinical, imaging, endoscopic, and/or histopathologic evidence."}
• {"criterion_text":"- Ileostomy for at least 3 months."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation, and strictures caused by previousradiation therapy."}
• {"criterion_text":"- Strictures/stenoses preventing passage of endoscope throughout the specified segment (up to 25 cm of ileum)"}
• {"criterion_text":"- Short bowel syndrome."}
• {"criterion_text":"- Within 3 months prior to screening: -Diagnosis of peritonitis or need treatment of peritonitis -Bowel perforation or evidence of obstruction"}
• {"criterion_text":"- All intrabdominal, cutaneous and perianal/perirectal abscessesand fistulae are excluded with exception of: cutaneous and perianal/perirectal abscesses which are adequately drained 4 weeks prior to randomisation, and intraabdominal fistulae between bowel segments only without complications"}
• {"criterion_text":"- Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable)."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Reversal of ileostomy or formation of J-pouch planned prior to end of study period."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs.","definition_or_measurement_approach":"Defined/measured using adverse events (AEs), clinical laboratory assessments, vital sign measures and 12-lead ECG recordings."}

Secondary endpoints

• {"endpoint_text":"- Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs since week12 to week 52.","definition_or_measurement_approach":"Safety and tolerability assessed by AEs, clinical laboratory assessments, vital signs and 12-lead ECGs from week 12 to week 52."}
• {"endpoint_text":"- a) Change from baseline in endoscopic score (SES CD using endoscopic assessment) at Week 12. b) Change from baseline in endoscopic score (MM SES-CD) at Week 12. c) Endoscopic response (≥ 50% decrease from baseline in SES-CD total score) at Week 12. d) Endoscopic remission (SES-CD total score < 4 and at least 2‑point reduction from baseline with no subscore > 1 in any individual variable) at Week 12.","definition_or_measurement_approach":"Endoscopic outcomes measured by SES-CD (Simple Endoscopic Score for Crohn's Disease) and MM SES-CD with central blinded reader scoring; definitions include ≥50% decrease for response and SES-CD total score <4 plus ≥2-point reduction with no subscore >1 for remission at Week 12."}
• {"endpoint_text":"- a) Serum AZD7798 concentration. b) Incidence and titre of ADA response","definition_or_measurement_approach":"Pharmacokinetics measured as serum AZD7798 concentration; immunogenicity assessed by incidence and titre of anti-drug antibody (ADA) responses."}

Sweden

Latest Decision Or Authorization Date

24-01-2025

Number Of Sites

3

Number Of Participants

6

Italy

Latest Decision Or Authorization Date

24-01-2025

Number Of Sites

3

Number Of Participants

4

Poland

Latest Decision Or Authorization Date

31-03-2026

Number Of Sites

5

Number Of Participants

10

Belgium

Latest Decision Or Authorization Date

20-03-2026

Number Of Sites

1

Number Of Participants

3

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden