A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
- Registration Number
- NCT04232553
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 778
- Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
- If female, participant must meet the contraception requirements
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mirikizumab IV and SC Mirikizumab Mirikizumab given intravenously (IV) and SC. Mirikizumab SC Mirikizumab Mirikizumab given subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Endoscopic Response Week 52 Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score
Percentage of Participants Achieving Clinical Remission Week 52 Clinical remission based on Crohn's Disease Activity Index (CDAI)
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Endoscopic Remission Week 52 Endoscopic remission based on SES-CD total score
Percentage of Participants Achieving Clinical Response Week 52 Clinical response by patient-reported outcomes (PRO) based on stool frequency (SF) and abdominal pain (AP)
Change from Baseline in Fecal Calprotectin Baseline, Week 12 Change from baseline in fecal calprotectin
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Baseline to Week 52 Change from baseline on the IBDQ
Change from Baseline in C-Reactive Protein Baseline, Week 12 Change from baseline in c-reactive protein
Trial Locations
- Locations (321)
Digestive Health Specialists
🇺🇸Dothan, Alabama, United States
Research Solutions of Arizona
🇺🇸Litchfield Park, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Phoenix, Arizona, United States
Care Access - Gilroy
🇺🇸Gilroy, California, United States
Newport Huntington Medical Group
🇺🇸Huntington Beach, California, United States
California Medical Research Associates
🇺🇸Northridge, California, United States
Connecticut Clinical Research Institute
🇺🇸Bristol, Connecticut, United States
Gastroenterology Consultants of Clearwater
🇺🇸Clearwater, Florida, United States
Clinical Research of West Florida, Inc. (Clearwater)
🇺🇸Clearwater, Florida, United States
IHS Health Research
🇺🇸Kissimmee, Florida, United States
Scroll for more (311 remaining)Digestive Health Specialists🇺🇸Dothan, Alabama, United States