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Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease.

A Phase Ib Open Label Positron Emission Tomography Study to Assess Changes in Intestinal [11C]AZ14132516 Uptake Following Administration of Multiple Doses of AZD7798 to Patients With Crohn's Disease.

NCT06432764•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to measure the changes in intestinal uptake of radioligand \[11C\]AZ14132516 following multiple doses of AZD7798 in participants with Crohn's disease.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must be ≥ 20 to 80 years of age, inclusive, at the time of signing the informed consent.
•Participants with confirmed Crohn's disease with small bowel involvement (Montreal terminal ileum \[L1\] or ileocolon \[L3\]) per study gastroenterologist (diagnosed via combination of clinical findings and at least one of endoscopy and/or histology and/or imaging) with diagnosis made at least 6 months before screening.
•Participants with active Crohn's disease as determined by one of the following:
•1. Evidence of active inflammation on cross-sectional imaging (CT, MRI or bowel ultrasound scan) or endoscopy within 6 months before screening OR EITHER
•2. If no cross-sectional imaging or endoscopy performed within 6 months before screening, a bowel ultrasound scan may be performed to confirm active disease OR
•3. If no cross-sectional imaging or endoscopy performed within 6 months before screening, elevated faecal calprotectin AND CRP
•Body habitus compatible with PET examination.
•Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•Capable of giving signed informed consent
•Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.

Exclusion Criteria

•Other form of IBD or concomitant, additional, active GI luminal inflammatory diseases.
•CMV colitis within 12 months before screening.
•Crohn's complications including short bowel syndrome, strictures that are symptomatic or with pre-stenotic dilatation or other conditions where surgery anticipated during study period.
•Planned bowel or perianal surgery within 6 months before screening.
•Bowel resection surgery within 6 months before screening.
•Undrained fistula or abscess (including active perianal disease).
•Positive Clostridium difficile toxin test during screening.
•Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, GI disease, or other major diseases other than active Crohn's disease and associated extra-intestinal manifestations.
•Ongoing psychiatric conditions that in the opinion of the Investigator, precludes study participation.
•History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to biologic therapies.
+28 more criteria

Locations (1)

Research Site

Stockholm, Sweden

Key Dates

Start Date

October 16, 2024

Primary Completion Date

April 16, 2026

Completion Date

April 16, 2026

Last Updated

February 23, 2026

Enrollment

ACTUAL participants

Conditions

Crohn Disease

Interventions

AZD7798

DRUG

[11C]AZ14132516

DRUG

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

View study

RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

NCT07089420

IBD (Inflammatory Bowel Disease)IBS - Irritable Bowel Syndrome+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease.

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

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Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study