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
Rialto, California 92377
Principal Investigator: Zeid Kayali
Phone: 909-883-2999
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Principal Investigator: Mark Fleisher
Phone: 904-680-0871
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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...
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Charlotte, North Carolina 28203
Principal Investigator: John Hanson
Phone: 704-355-4593
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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...
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Chula Vista, California 91910
Principal Investigator: Cynthia Schaeffer
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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...
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Monroe, Louisiana 71201
Principal Investigator: Bal Raj Bhandari
Phone: 318-807-0819
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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...
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1045 East 3900 South
Salt Lake City, Utah 84124
Salt Lake City, Utah 84124
Principal Investigator: Ronald Joseph
Phone: 801-893-1788
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