Actively Recruiting
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Led by AstraZeneca · Updated on 2026-03-16
30
Participants Needed
22
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosis of Crohn's disease confirmed by clinical and imaging, endoscopic, or histopathologic evidence
- Ileostomy (including Kock pouch) for at least 3 months
- Clinical suspicion of active ileal inflammation based on previous endoscopy, imaging, or fecal calprotectin above normal
- Active ileal Crohn's disease confirmed by ileoscopy with a SES-CD score 5 4 in the ileal segment 5 to 25 cm proximal to the stoma
- Ability to provide signed informed consent
You will not qualify if you...
- Additional gastrointestinal inflammatory diseases such as infectious enteritis or ischemic bowel
- Strictures or stenoses blocking passage of the endoscope in the ileum segment
- Short bowel syndrome
- Recent (within 3 months) peritonitis diagnosis or treatment, bowel perforation, or obstruction
- Unresolved abdominal, cutaneous, or perianal abscesses or fistulae except adequately drained ones 4 weeks prior to randomization
- Dependency on total enteral or parenteral nutrition during the study
- Increased colorectal cancer risk including unresected polyps, dysplasia, or inadequate surveillance
- Planned reversal of ileostomy or J-pouch formation before study end
- High-output stoma (>2000 mL/24h) with volume depletion or electrolyte disturbance
- Recent use of certain biologics, immunosuppressants, advanced Crohn's treatments, live vaccines, fecal microbiota transplantation, or NSAIDs as specified
- Recent infection or positive tests for hepatitis B or C, tuberculosis, serious opportunistic infections, symptomatic herpes zoster, or C. difficile toxin
- Immunodeficiency conditions including HIV, splenectomy, organ transplantation (except corneal), or primary immune deficiencies except selective IgA deficiency
- Abnormal lab results including low hemoglobin, neutrophils, lymphocytes, liver function abnormalities, or low kidney function
- Prolonged QT interval or certain cardiovascular diseases
- Pregnancy, breastfeeding, or refusal to use effective contraception
- Current or recent malignancy except certain skin and non-gastrointestinal cancers in remission
- Major unstable diseases other than active Crohn's disease
- Participation in other interventional studies or recent investigational drug use
- Unstable lifestyle factors interfering with study completion
- Institutionalization by legal order
- Involvement in study planning or conduct
- Previous randomization in this study
- Inability or unwillingness to comply with study procedures
- Hypersensitivity to study drug or excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Research Site
Leuven, Belgium, 3000
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2
Research Site
Padova, Italy, 35121
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3
Research Site
Roma, Italy, 00168
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4
Research Site
Rozzano, Italy, 20089
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5
Research Site
Amsterdam, Netherlands, 1081 HV
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6
Research Site
Nijmegen, Netherlands, 6525 GA
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7
Research Site
Lodz, Poland, 91-495
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8
Research Site
Poznan, Poland, 60-324
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9
Research Site
Poznan, Poland, 60-529
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10
Research Site
Warsaw, Poland, 04-501
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11
Research Site
Wroclaw, Poland, 52-210
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12
Research Site
Gothenburg, Sweden, 41345
Withdrawn
13
Research Site
Linköping, Sweden, 581 85
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14
Research Site
Stockholm, Sweden, 17176
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15
Research Site
Kyiv, Ukraine, 02002
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16
Research Site
Kyiv, Ukraine, 04210
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17
Research Site
Vinnytsia, Ukraine, 21029
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18
Research Site
Birmingham, United Kingdom, B15 2GW
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19
Research Site
Cambridge, United Kingdom, CB2 0XY
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20
Research Site
London, United Kingdom, E1 1BB
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21
Research Site
London, United Kingdom, NW10 7NS
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22
Research Site
London, United Kingdom, WC1E 6AG
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Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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