Patients with Active Ulcerative Colitis
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2021/10/037037
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
1. Have moderately to severely active ulcerative colitis (UC) as defined by a modified Mayo score (MMS) of 4 to 9 with an endoscopic subscore (ES) =2, with endoscopy performed within 14 days before baseline.
2. Have evidence of UC extending proximal to the rectum (with =15 centimeters (cm) of involved colon).
3. Have up-to-date colorectal cancer surveillance performed according to local standard.
4. Participants are either one of the following:
5. Have failed conventional treatments including inability to tolerate oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine or methotrexate), or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) and neither failed or demonstrated intolerance to advanced therapy (eg, tumor necrosis factor (TNF) antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase (JAK) inhibitor) OR,
6. Have failed advanced therapies such as treatment with 1 or more advance therapies (eg, tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase [JAK] inhibitor) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment.
7. Have had an established diagnosis of UC of =3 months in duration before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. Supportive endoscopy and histopathology reports must be available in the source documents.
8. Women of child-bearing potential (WOCBP) must test negative for pregnancy as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to first exposure to study drug.
1. Have had or will need abdominal surgery for UC.
2. Have received any of the following for treatment of UC: cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 2 weeks of screening, rectally administered corticosteroids or 5-aminosalicylic acid treatments within 2 weeks of screening.
3. Have had or will need abdominal surgery for UC.
4. Have failed 3 or more classes of advanced therapies approved for treatment of UC.
5. Have evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
6. Have any history or evidence of cancer of the gastrointestinal tract.
7. Have myocardial infarction, unstable ischemic heart disease, stroke or heart failure within 12 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants in Clinical RemissionTimepoint: Week 12
- Secondary Outcome Measures
Name Time Method 1. Percentage of Participants Who Achieved Clinical Response. <br/ ><br>2. Percentage of Participants Who Achieved Endoscopic Remission. <br/ ><br>3. Percentage of Participants Who Achieved Endoscopic Response. <br/ ><br>4. Percentage of Participants Who Achieved Symptomatic Response. <br/ ><br>5. Percentage of Participants Who Achieved Symptomatic Remission. <br/ ><br>6. Percentage of Participants Who Achieved Histologic Remission. <br/ ><br>7. Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing. <br/ ><br>8. Pharmacokinetics (PK) of LY3471851 Trough ConcentrationTimepoint: Week 12;Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)Timepoint: Baseline, Week 12