Clinical Trials in Mexico / NCT04232553
Active, not recruiting
Phase 3
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
NCT04232553 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
Crohn's Disease
Study 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.
Eligibility
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) | Clearwater | Florida | |
| IHS Health Research | Kissimmee | Florida | |
| Ezy Medical Research | Miami | Florida | |
| Care Access - Orlando | Orlando | Florida | |
| Gastroenterology Associates of Pensacola, PA | Pensacola | Florida | |
| Precision Clinical Research | Sunrise | Florida | |
| USF Health | Tampa | Florida | |
| Alliance Clinical Research of Tampa | Tampa | Florida | |
| Digestive Healthcare of Georgia | Atlanta | Georgia | |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | |
| Grand Teton Research Group | Idaho Falls | Idaho | |
| Qualmedica Research, LLC | Evansville | Indiana | |
| Indiana University Health University Hospital | Indianapolis | Indiana | |
| Delta Research Partners | Monroe | Louisiana | |
| Capital Digestive Care - Chevy Chase | Chevy Chase | Maryland | |
| Woodholme Gastroenterology Associates - Glen Burnie | Glen Burnie | Maryland | |
| The Digestive Health Center of Michigan (DHCMI) | Chesterfield | Michigan | |
| Revive Research Institute, Inc. | Farmington Hills | Michigan | |
| MNGI Digestive Health - Plymouth Endoscopy Center & Clinic | Plymouth | Minnesota | |
| Washington University Medical School | St Louis | Missouri | |
| Care Access - Las Vegas | Las Vegas | Nevada | |
| Holy Name Medical Center | Teaneck | New Jersey | |
| Clinical & Translational Research Center (CTRC) | Chapel Hill | North Carolina | |
| Carolina Digestive Diseases and Endoscopy Center | Greenville | North Carolina | |
| Care Access - Kinston | Kinston | North Carolina | |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | |
| Ohio Gastroenterology | Columbus | Ohio | |
| Ohio State University | Hilliard | Ohio | |
| North Shore Gastroenterology & Endoscopy Centers | Westlake | Ohio | |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | |
| University Gastroenterology | Providence | Rhode Island | |
| Gastroenterology Associates of Orangeburg | Orangeburg | South Carolina |
+ 282 more sites — see the full list on the official registry below.
On this site
📄 Omvoh (mirikizumab) drug profile →More Eli Lilly and Company trials in Mexico
Other trials for the same condition
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Recruiting
Official registry record
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.
View NCT04232553 on ClinicalTrials.gov ↗ ← All trials in Mexico