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

NCT06681324 | Recruiting Phase 2 DMC

• 1 other identifier: D9690C00006
• Study Type: interventional
• Target: 30
• Locations: 7 countries
• Sites: 22

Brief 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.

Conditions

Crohn's Disease

Keywords

Crohn's disease; ileostomy; inflammation; small bowel; stoma

Outcome Measures

Primary Outcomes (12)

• Number of participants with adverse events

  Summary of any adverse events and also by MedDRA SOC and Preferred term

  from Week 0 to Week 12

• Number of participants with abnormal Vital signs: Blood pressure

  Systolic and diastolic blood pressure will be summarized by descriptive statistics

  from Week 0 to Week 12

• Number of participants with abnormal Vital signs: Pulse rate

  Pulse rate will be summarized by descriptive statistics

  from Week 0 to Week 12

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

  The variables platelet count, red blood cell (RBC) count, haemoglobin, haematocrit will be summarized with descriptive statistics

  from Week 0 to Week 12

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

  The variables neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be summarized with descriptive statistics

  from Week 0 to Week 12

• Number of participants with abnormal values in haematology: RBC

  The variables mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and percentage of reticulocytes will be summarized with descriptive statistics

  from Week 0 to Week 12

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

  The variables creatinine and blood urea nitrogen (BUN) will be summarized with descriptive statistics

  from Week 0 to Week 12

• Number of participants with abnormal values in clinical chemistry: electrolytes

  The variables potassium, sodium, and calcium will be summarized with descriptive statistics

  from Week 0 to Week 12

• Number of participants with abnormal values in clinical chemistry: liver function

  The variables ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), and ALP (alkaline phosphatase), and albumin will be summarized with descriptive statistics

  from Week 0 to Week 12

• Number of participants with abnormal values in clinical chemistry: hs-CRP

  The variable hs-C-reactive protein will be summarized with descriptive statistics

  from Week 0 to Week 12

• Number of participants with abnormal values in clinical chemistry: glucose

  The variable glucose will be summarized with descriptive statistics

  from Week 0 to Week 12

• Number of participants with abnormal values in ECG readings

  12-lead ECGs will be obtained using an ECG machine, that automatically measures RR/HR, PR, QRS, QT and Corrected QT (QTc) intervals, and summarized with descriptive statistics

  from Week 0 to Week 12

Secondary Outcomes (18)

• Difference in mean change from baseline in endoscopic score between active and placebo

  Week 12

• Number of participants with endoscopic response

  Week 12

• Number of participants with endoscopic remission

  Week 12

• Serum AZD7798 concentration

  up to 52 Weeks

• Incidence of anti-drug antibody response

  up to 52 Weeks

Study Arms (2)

AZD7798

EXPERIMENTAL

AZD7798

Drug: AZD7798

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

AZD7798 DRUG

AZD7798

AZD7798

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age.
• 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 from 5 to 25 cm (20cm length) proximal to the stoma. Participants with inflammation in additional intestinal segments are not excluded.
• Capable of giving signed informed consent.

You may not qualify if:

• Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation and strictures caused by previous radiation 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 randomization, and intra-abdominal fistulae between bowel segments only without complications
• Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable).
• In participants with any remaining colon and/or rectum, evidence of an increased risk of colorectal cancer, including:
• 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)
• 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 participant 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (22)

Research Site

Leuven, 3000, Belgium

RECRUITING

Research Site

Padua, 35121, Italy

RECRUITING

Research Site

Roma, 00168, Italy

RECRUITING

Research Site

Rozzano, 20089, Italy

RECRUITING

Research Site

Amsterdam, 1081 HV, Netherlands

RECRUITING

Research Site

Nijmegen, 6525 GA, Netherlands

RECRUITING

Research Site

Lodz, 91-495, Poland

RECRUITING

Research Site

Poznan, 60-324, Poland

RECRUITING

Research Site

Poznan, 60-529, Poland

RECRUITING

Research Site

Warsaw, 04-501, Poland

RECRUITING

Research Site

Wroclaw, 52-210, Poland

RECRUITING

Research Site

Gothenburg, 41345, Sweden

WITHDRAWN

Research Site

Linköping, 581 85, Sweden

RECRUITING

Research Site

Stockholm, 17176, Sweden

RECRUITING

Research Site

Kyiv, 02002, Ukraine

RECRUITING

Research Site

Kyiv, 04210, Ukraine

RECRUITING

Research Site

Vinnytsia, 21029, Ukraine

RECRUITING

Research Site

Birmingham, B15 2GW, United Kingdom

RECRUITING

Research Site

Cambridge, CB2 0XY, United Kingdom

RECRUITING

Research Site

London, E1 1BB, United Kingdom

RECRUITING

Research Site

London, NW10 7NS, United Kingdom

RECRUITING

Research Site

London, WC1E 6AG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammation

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 2:1 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.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: November 8, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 3, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

SE (3); GB (5); NL (2); BE (1); PL (5); UA (3); IT (3)