ong-Term Efficacy and Safety of Mirikizumab in Patients with Crohns Disease

Phase 3

• Conditions: Health Condition 1: K509- Crohns disease, unspecified

• Registration Number: CTRI/2022/03/041498
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130).

2. If female, participant must meet the contraception requirements.

Exclusion Criteria

1. Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.

2. Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study. (Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.)

3. Participants must not have developed adenomatous polyps during the originator study that have been removed prior to the start of this study.

4. Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.

5. Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Endoscopic Response.Timepoint: Week 52

Secondary Outcome Measures

Name	Time	Method
1. Change from Baseline in C-Reactive Protein. <br/ ><br>2. Change from Baseline in Fecal Calprotectin.Timepoint: Baseline, Week 12;1. Percentage of Participants Achieving Clinical Remission. <br/ ><br>2. Percentage of Participants Achieving Endoscopic Remission. <br/ ><br>3. Percentage of Participants Achieving Clinical Response.Timepoint: Week 52;Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ).Timepoint: Baseline to Week 52