I6T-MC-AMAX; A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn’s Disease

The primary objective of this study is to evaluate the long-term **efficacy** and safety of **mirikizumab** in patients with **Crohn's Disease**. This is clinically relevant as it aims to provide insights into the sustained therapeutic benefits and potential risks associated with prolonged use of mirikizumab, a treatment option for managing this chronic inflammatory bowel disease. The study does not list any secondary objectives.

The clinical trial involves a total of **442 participants** diagnosed with **Crohn's Disease**. The study population includes both male and female subjects, with an age range that spans from 18 to 64 years. Participants were selected based on their completion of previous studies, specifically study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130). The trial includes a vulnerable population, indicating that special considerations are in place to ensure their safety and well-being. Participants' general health status is consistent with the requirements for individuals with Crohn's Disease, and they must adhere to specific contraception requirements if female. The selection process ensures a diverse representation of individuals affected by this condition, providing valuable insights into the long-term efficacy and safety of mirikizumab.

The clinical trial is designed to evaluate the long-term efficacy and safety of **mirikizumab** in patients with **Crohn's disease**. This is a Phase 3, multicenter, open-label, long-term extension study. Participants eligible for this trial must have completed either study I6T-MC-AMAG or study I6T-MC-AMAM. The trial is expected to run from September 16, 2020, to December 20, 2026, with the primary endpoints being the percentage of participants achieving endoscopic response and clinical remission at Week 52.

The trial involves a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the completion of prior studies and adherence to contraception requirements for female participants. Following the screening, participants will undergo regular follow-up visits to monitor their response to the treatment and assess any adverse effects. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the long-term outcomes of the treatment.

Participant involvement is expected to last until the end of the study in December 2026, unless early termination is warranted. Conditions that may lead to early termination include non-compliance with study protocols, withdrawal of consent, or the occurrence of significant adverse events. The study employs a solution for injection or infusion of mirikizumab, with no maximum daily or total dose specified, and the treatment period is set for one year. The trial is not categorized as low intervention and is conducted to confirm the safety and efficacy of the investigational medicinal product.

The clinical trial involves the administration of **Mirikizumab**, an investigational medication developed by Eli Lilly and Company Limited. Mirikizumab is formulated as a **solution for injection** and is intended for use in patients with Crohn's disease. The pharmaceutical form of Mirikizumab is a solution for injection, which can be administered either as an infusion or via a pre-filled syringe. The active substance, mirikizumab, is a protein of other origin, specifically designed to target inflammatory pathways involved in Crohn's disease. The sponsor product code for Mirikizumab is LY3074828. The trial does not specify a maximum daily dose or total dose amount, and the maximum treatment period is set at one unit of time, as defined by the trial protocol.

In addition to the experimental treatment, the study may include the use of standard-of-care therapies as deemed necessary by the clinical investigators. However, no specific non-experimental treatments, such as placebo or comparator treatments, are explicitly mentioned in the trial documentation. The administration of Mirikizumab is monitored to ensure participant compliance, although specific compliance monitoring strategies are not detailed in the available data. The trial aims to evaluate the long-term efficacy and safety of Mirikizumab in patients with Crohn's disease, providing valuable insights into its therapeutic potential.

The efficacy of **mirikizumab** in the clinical trial will be assessed through primary endpoints that include the percentage of participants achieving an endoscopic response and clinical remission. The endoscopic response will be evaluated based on the Simple Endoscopic Score for Crohn's Disease (SES-CD) total score, while clinical remission will be determined using the Crohn's Disease Activity Index (CDAI). These assessments are scheduled to occur at Week 52 of the trial.