Ulcerative Colitis
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy clinical remission | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics other clinical response, endoscopic remission, adverse events, PK profile, health outcome | — |
Countries
Europe, Japan, North America, Oceania
Outcome results
None listed