Crohn´s Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants who have completed the Phase 2 Study I6T-MC-AMAG (EudraCT 2016- 002204-84), and in the opinion of the investigator, would derive clinical benefit from continued treatment with mirikizumab 2. Participants who have completed the Phase 3 Study I6T-MC-AMAM (2018-004614-18) and in the opinion of the investigator would derive clinical benefit from treatment with mirikizumab Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 708 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: -Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) -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 CDC and/or WHO criteria prior to the originator study are not excluded from the study. -Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study. -Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced an acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy. -Participants 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of mirikizumab in the maintenance of endoscopic response in participants from AMAM who completed treatment on blinded SC mirikizumab and achieved endoscopic response at Week 52 of AMAM;Secondary Objective: To evaluate the long-term effect of mirikizumab on health outcomes;Primary end point(s): Proportion of participants achieving clinical remission based on the Crohns Disease Activity Index (CDAI). Proportion of participants achieving endoscopic response. Endoscopic response is based on SES-CD score.;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Proportion of participants with clinical response by CDAI. -Proportion of participants achieving clinical remission. Clinical remission is based on the Patient Reported Outcome (PRO) of stool frequency (SF) and abdominal pain (AP). -Proportion of participants achieving endoscopic remission. Endoscopic remission is based on SES-CD score. -IBDQ scores over time. ;Timepoint(s) of evaluation of this end point: Week 12, 52, 100, 156 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed