Evaluation of Pharmacokinetics, Safety, and Tolerability of Obefazimod in Patients with Renal Impairment and Normal Renal Function with Ulcerative Colitis

The primary objective of this Phase I study is to evaluate the **pharmacokinetics**, safety, and tolerability of multiple oral doses of obefazimod in participants with renal impairment compared to those with matched normal kidney function. This is clinically relevant as it aims to understand how renal impairment affects the drug's behavior in the body, which is crucial for optimizing dosing regimens and ensuring patient safety, particularly in individuals with compromised kidney function. The study focuses on participants with moderately to severely active **ulcerative colitis**, a chronic inflammatory bowel disease, to assess the potential impact of renal function on the treatment's efficacy and safety profile.

The clinical trial involves participants diagnosed with **moderately to severely active ulcerative colitis**. The study population includes both male and female subjects, with an age range spanning from young adults to older adults. The trial population was selected to include a vulnerable population, although specific details regarding the selection process or lifestyle considerations such as diet, physical activity, or habits are not provided. The total number of participants in the study is not disclosed, as the sponsor has not provided this information. Key inclusion or exclusion criteria are not specified in the available data.

The clinical trial is designed to evaluate the **pharmacokinetics**, safety, and tolerability of multiple oral doses of obefazimod in participants with renal impairment and those with matched normal kidney function. This is a Phase III study focusing on individuals with moderately to severely active **ulcerative colitis**. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated recruitment start date is September 9, 2024, with an anticipated end date of July 15, 2025, indicating an overall trial duration of approximately 10 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. Throughout the study, there will be scheduled follow-up visits to monitor the participants' health status, adherence to the study protocol, and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the trial. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the long-term effects of the treatment.

The expected length of participant involvement is contingent upon the study's timeline, with each participant expected to remain in the trial until its completion unless specific conditions necessitate early termination. Such conditions may include significant adverse reactions, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial is structured to ensure the safety and well-being of all participants while providing valuable data on the efficacy and safety of obefazimod in the target population.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a paediatric formulation or if it has orphan drug status. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available in the provided data.

The clinical trial is a Phase 3 study, with an estimated recruitment start date of September 9, 2024, and an estimated end date of July 15, 2025. Efficacy will be assessed through a structured evaluation process, although specific parameters or endpoints for efficacy assessment are not detailed in the available data. The trial will follow a systematic approach to measure, collect, and analyze efficacy data, adhering to the rigorous standards typical of Phase 3 trials. The trial's design will likely involve the use of validated scales, laboratory tests, or patient-reported outcomes to ensure the reliability and validity of the efficacy assessments. The schedule for these assessments will be aligned with the trial's protocol, ensuring that data is collected at appropriate timepoints to accurately reflect the treatment's impact. The trial's methodology will be designed to provide robust evidence on the efficacy of the intervention under investigation, contributing to the overall understanding of its therapeutic potential.