A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
| Status: | Active, not recruiting | 
|---|---|
| Conditions: | Colitis, Colitis, Gastrointestinal | 
| Therapuetic Areas: | Gastroenterology | 
| Healthy: | No | 
| Age Range: | 18 - 75 | 
| Updated: | 12/21/2018 | 
| Start Date: | December 9, 2015 | 
| End Date: | March 29, 2019 | 
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis
The main purpose of this study is to test the hypothesis that treatment with mirikizumab is
superior to placebo in providing clinical benefit to participants with moderate to severe
ulcerative colitis (UC). This study will also investigate how the body processes the drug.
			superior to placebo in providing clinical benefit to participants with moderate to severe
ulcerative colitis (UC). This study will also investigate how the body processes the drug.
Inclusion Criteria:
- Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an
endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note:
a partial Mayo score of at least 4 and other eligibility criteria must have been met
before endoscopy is performed as a study procedure)
- Have evidence of UC extending proximal to the rectum (≥15 centimeters [cm] of involved
colon)
- Up-to-date colorectal cancer surveillance (performed according to local standard), for
subjects with family history of colorectal cancer, personal history of increased
colorectal cancer risk, age >50 years, or other known risk factor
- Participants must either: be naive to biologic therapy (eg, tumor necrosis factor
[TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate
response or failure to tolerate current treatment with oral or intravenous
corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of
corticosteroid dependence (an inability to successfully taper corticosteroids without
return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF
antagonists or vedolizumab) at doses approved for the treatment of UC with documented
history of failure to respond to or tolerate such treatment
Exclusion Criteria:
- Have been diagnosed with indeterminate colitis, proctitis (distal disease involving
the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
- Have had surgery for treatment of UC or are likely to require surgery for UC during
the study
- Have received any of the following for treatment of UC: cyclosporine or thalidomide
within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or
topical treatment with 5-aminosalicyclic acid within 30 days of screening
We found this trial at
    12
    sites
	
									4800 Belfort Rd # 2
Jacksonville, Florida 32256
	
			
					Jacksonville, Florida 32256
Principal Investigator: Mark Fleisher
			
						
										Phone: 904-680-0871
					Click here to add this to my saved trials
	
									500 S State St
Ann Arbor, Michigan 48109
	
			Ann Arbor, Michigan 48109
(734) 764-1817 
							
					Principal Investigator: Peter Higgins
			
						
										Phone: 734-647-2964
					
		University of Michigan The University of Michigan was founded in 1817 as one of the...  
  
  Click here to add this to my saved trials
	
								Charlotte, North Carolina 28203			
	
			
					Principal Investigator: John Hanson
			
						
										Phone: 704-355-4593
					Click here to add this to my saved trials
	
									 5841 S Maryland Ave
Chicago, Illinois 60637
	
			Chicago, Illinois 60637
(773) 702-1000
							
					Principal Investigator: David Rubin
			
						
										Phone: 773-702-2950
					
		University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...  
  
  Click here to add this to my saved trials
	
								Chula Vista, California 91910			
	
			
					Principal Investigator: Cynthia Schaeffer
			
						
								Click here to add this to my saved trials
	Click here to add this to my saved trials
	
									9500 Gilman Dr
La Jolla, California 92093
	
			La Jolla, California 92093
(858) 534-2230
							
					Principal Investigator: Brigid Boland
			
						
										Phone: 858-657-5279
					
		The University of California, San Diego UC San Diego is an academic powerhouse and economic...  
  
  Click here to add this to my saved trials
	
								Monroe, Louisiana 71201			
	
			
					Principal Investigator: Bal Raj Bhandari
			
						
										Phone: 318-807-0819
					Click here to add this to my saved trials
	
									630 W 168th St
New York, New York
	
			New York, New York
212-305-2862 
							
					Principal Investigator: Simon Lichtiger
			
						
										Phone: 201-446-4661
					
		Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...  
  
  Click here to add this to my saved trials
	Click here to add this to my saved trials
	
								Rialto, California 92377			
	
			
					Principal Investigator: Zeid Kayali
			
						
										Phone: 909-883-2999
					Click here to add this to my saved trials
	
									1045 East 3900 South
Salt Lake City, Utah 84124
	
			
					Salt Lake City, Utah 84124
Principal Investigator: Ronald Joseph
			
						
										Phone: 801-893-1788
					Click here to add this to my saved trials