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

NCT06432764 | Completed Phase 1 FDA Drug

• 2 other identifiers: D9690C000072024-512992-11-00
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in intestinal SUV/SUVR

  Standardized uptake value (SUV) is the radioactivity concentration in given region of interest normalized for injected radioactivity and body weight. Standardised uptake value ratio (SUVR) is the ratio of SUV in a given region of interest to a reference region without significant radioligand uptake

  Weeks 13, 16, 20 and 24 (may vary between participants)

Secondary Outcomes (2)

• Serum AZD7798 concentration

  Weeks 0, 4, 8, 12 (may vary between participants)

• Incidence and titre of anti-drug antibodies

  Week 0, 4, 8, 12 and 24 (may vary between participants)

Other Outcomes (1)

• Number of participants with safety findings, AEs

  Until final follow-up, week 24 (may vary between participants)

Study Arms (1)

AZD7798

EXPERIMENTAL

Arm consists of up to 2 panels

Drug: AZD7798; Drug: [11C]AZ14132516

Interventions

AZD7798 DRUG

Each participating patient will receive the study drug as specified in the study protocol.

Also known as: Study Drug

AZD7798

[11C]AZ14132516 DRUG

A single microdose (≤ 10 μg) of radiopharmaceutical \[11C\]AZ14132516 will be extemporaneously prepared and administered to each participant prior to each PET examination

Also known as: Radioligand

AZD7798

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Evidence of active inflammation on cross-sectional imaging (CT, MRI or bowel ultrasound scan) or endoscopy within 6 months before screening OR EITHER
• 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
• 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.

You may not qualify if:

• 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.
• Participants with unstable hypertension (as judged by the Investigator) or symptomatic hypotension, history of pre-syncope or syncope due to orthostatic hypotension and/or induced by change of posture.
• Significant abnormalities on clinical examination, including neurological and physical examination, vital signs, and ECG, other than signs of Crohn's disease.
• Clinical chemistry, haematology, or urine analysis results that may interfere with the study or present a safety risk to the participant.
• Abnormal vital signs, after 10 minutes of supine rest as judged by the Investigator.
• Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG that may interfere with the interpretation of QTc changes.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Drug Evaluation; Radioligand Assay

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Diagnostic Techniques, Radioisotope

Study Officials

• Maria Creignou

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open label study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: October 16, 2024
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

SE (1)