Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 80 Years|
- - Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
- - Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
- - If female, must meet the contraception requirements.
- - Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
- - Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
- - Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
- - Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
- - Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
- - Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Eli Lilly and Company|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)|
|Principal Investigator Affiliation||Eli Lilly and Company|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Argentina, Australia, Austria, Belgium, Canada, China, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Mirikizumab Dose #1
Mirikizumab Dose #1 administered subcutaneously (SC)
Experimental: Mirikizumab Dose #2
Mirikizumab Dose #2 administered intravenously (IV)
Placebo Comparator: Placebo
Placebo administered SC
Drug: - Mirikizumab
Drug: - Mirikizumab
Drug: - Placebo
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.