Evaluation of [11C]AZ14132516 Uptake Alterations Post-Multiple AZD7798 Doses in Crohn's Disease Patients via PET Imaging.

The primary objective of this study is to evaluate the changes in **[11C]AZ14132516** uptake using PET imaging following the administration of multiple doses of **AZD7798** in patients diagnosed with **Crohn's disease**. This is clinically relevant as it may provide insights into the drug's pharmacodynamics and its potential therapeutic effects on inflammatory processes associated with Crohn's disease.

The clinical trial involves participants diagnosed with **Crohn's disease**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial population was selected to include a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants' general health status, lifestyle considerations such as diet, physical activity, or habits, and specific inclusion or exclusion criteria have not been disclosed. The sponsor has not provided information on the total number of participants involved in the study.

The clinical trial is designed to evaluate the changes in **[11C]AZ14132516** uptake following the administration of multiple doses of **AZD7798** in patients diagnosed with **Crohn's disease**. This study is structured as a Phase 3, randomized, double-blind, controlled trial, ensuring the reliability and validity of the results. The trial is expected to commence recruitment on August 30, 2024, and is projected to conclude by February 16, 2026, providing a comprehensive timeline for data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough evaluation to confirm the diagnosis of **Crohn's disease** and ensure the absence of any exclusion criteria. Following successful screening, participants will be randomized to receive either the investigational product or a control, with neither the participants nor the investigators aware of the group assignments, maintaining the double-blind nature of the trial.

Throughout the study, participants will attend regular follow-up visits to monitor their response to the treatment and assess any potential adverse effects. These visits will include clinical assessments, laboratory tests, and imaging studies to evaluate the uptake of **[11C]AZ14132516**. The frequency and specific procedures of these visits will be determined by the study protocol, ensuring consistent data collection across all participants.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial. During this visit, final assessments will be conducted to gather comprehensive data on the treatment's efficacy and safety. The expected length of participant involvement will vary depending on the individual's response to treatment and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or non-compliance with study procedures.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy within a Phase 3 framework. The trial is scheduled to commence recruitment on August 30, 2024, with an estimated completion date of February 16, 2026. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology for measuring, collecting, and analyzing these efficacy parameters, consistent with the standards of Phase 3 trials. The schedule for assessments and the tools or instruments to be used are not specified in the available information. The trial's focus is on obtaining robust data to support the efficacy claims of the investigational product, adhering to rigorous clinical and scientific standards.