I6T-MC-AMAC
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-jRCT2080223301
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>clinical remission
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>other<br>clinical response, endoscopic remission, adverse events, PK profile, health outcome