A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Study Overview
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Brief Summary
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The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Mirikizumab
* Drug: Mirikizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130) If female, participant must meet the contraception requirements Exclusion Criteria: 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. 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. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirikizumab SC<br>Mirikizumab given subcutaneously (SC). | Drug: Mirikizumab<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab IV and SC<br>Mirikizumab given intravenously (IV) and SC. | Drug: Mirikizumab<br>* Administered IV<br>* Other names: LY3074828;Drug: Mirikizumab<br>* Administered SC<br>* Other names: LY3074828;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Endoscopic Response | Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score | Week 52 | 
| Percentage of Participants Achieving Clinical Remission | Clinical remission based on Crohn's Disease Activity Index (CDAI) | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Endoscopic Remission | Endoscopic remission based on SES-CD total score | Week 52 | 
| Percentage of Participants Achieving Clinical Response | Clinical response by patient-reported outcomes (PRO) based on stool frequency (SF) and abdominal pain (AP) | Week 52 | 
| Change from Baseline in C-Reactive Protein | Change from baseline in c-reactive protein | Baseline, Week 12 | 
| Change from Baseline in Fecal Calprotectin | Change from baseline in fecal calprotectin | Baseline, Week 12 | 
| Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) | Change from baseline on the IBDQ | Baseline to Week 52 |