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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Percentage of Participants Achieving Endoscopic Response at Week 52 (Participants Originating From AMAM Study) — Week 52 Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.
Percentage of Participants Achieving Clinical Remission at Week 52 (Participants Originating From AMAM Study) — Week 52 Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) total score \< (less than) 150. The CDAI measures the severity of active disease using 8 disease variables: stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations, presence or absence of fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight. Each variable is assigned a specific weight/multiplier, and the weighted values are summed to produce a CDAI total score. CDAI total scores can range from 0 to 600, with higher scores indicating more severe disease.
Trial sites (322)
Facility
City
Region
Status
Digestive Health Specialists
Dothan
Alabama
Research Solutions of Arizona
Litchfield Park
Arizona
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix
Arizona
Care Access - Gilroy
Gilroy
California
Newport Huntington Medical Group
Huntington Beach
California
California Medical Research Associates
Northridge
California
Connecticut Clinical Research Institute
Bristol
Connecticut
Gastroenterology Consultants of Clearwater
Clearwater
Florida
Clinical Research of West Florida, Inc. (Clearwater)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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