AzTrials
AzTrials

Crohn DiseasePhase 1NCT06432764

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

A Phase 1 study testing AZD7798 and [11C]AZ14132516 in people with Crohn Disease, run by AstraZeneca at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Crohn Disease
What is being tested?
AZD7798 and [11C]AZ14132516
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteSweden
Study dates
16 Oct 2024to 27 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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).
Show all 38Show fewer
  • 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.
  • Positive hepatitis B, hepatitis C, or HIV serology
  • Treatment with an anti-TNF within 8 weeks of the first dose and throughout the study period, before the first dose and throughout study period, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable.
  • Treatment with any biologic, other than an anti-TNF (including vedolizumab and ustekinumab) within 12 weeks prior to first dose and throughout the study period, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable.
  • Treatment with rituximab within 12 months before first dose and throughout the study period.
  • Treatment with Sphigosine-1-phosphate receptor modulators or Janus kinase inhibitors within 4 weeks before first dose and throughout the study period.
  • Treatment with apheresis (eg, Adacolumn, Cellsorba) within 2 weeks prior to first dose and throughout the study period.
  • Treatment with corticosteroids at a total daily dose of greater than 20 mg prednisone or equivalent (greater than 9 mg budesonide).
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or site staff).
  • Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
  • Suffers from claustrophobia that limits the ability to undergo the scanning procedure.
  • Positive SARS-CoV-2 rapid antigen test at screening.
  • Any other reason that, in the study Investigator opinion, prohibits the inclusion of the participants into the study.
  • Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
  • Live or attenuated vaccine within 4 weeks before screening and until 12 weeks after the end of the follow-up period (1 year for Bacillus Calmette-Guérin vaccination).
  • An active infection, or history of serious infection within 28 days before screening.
  • History of symptomatic herpes simplex (excluding cold sores) or herpes zoster infection within 3 months prior to screening.
  • Positive or indeterminate TB QuantiFERON test performed within 1 year of screening (without known interval exposure to TB) or during screening period unless evidence of completion of full treatment course for latent TB with no clinical symptoms or signs indicative of re activation.
  • Chest x-ray with signs of malignancy or latent or active TB infection performed within 1 year of screening (without known interval exposure to TB) or during screening period.
  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days/5 half-lives, whichever is longer, of the first administration of IMP in this study. The period of exclusion begins 30 days/5 half-lives after the final dose, whichever is longer, .
  • Current malignancy or history of malignancy, except for:
  • Basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to screening.
  • Other non-GI malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years before screening.
  • For females only: Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Research Site

    Stockholm, 14186

Other trials in Sweden

About this study

Official title: 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.

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
Being tested
AZD7798, [11C]AZ14132516
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD7798Drug

    Also called Study Drug

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

  • [11C]AZ14132516Drug

    Also called Radioligand

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

Study groups in NCT06432764
Study groupRoleWhat they receive
AZD7798ExperimentalArm consists of up to 2 panels
Receives: Drug: AZD7798; Drug: [11C]AZ14132516

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)

  1. Serum AZD7798 concentration

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

  2. Incidence and titre of anti-drug antibodies

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start16 Oct 2024
  3. Primary completion27 Mar 2026
  4. Study completion27 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06432764
Sponsor's protocol ID
D9690C00007
Other IDs
2024-512992-11-00
Status last verified
Apr 2026
First submitted
22 May 2024
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD7798 and [11C]AZ14132516 in people with Crohn Disease, run by AstraZeneca at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in intestinal SUV/SUVR (time frame: Weeks 13, 16, 20 and 24 (may vary between participants)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06432764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in