A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: LY3471851; Placebo
Intervention description: administered SC; administered SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: T regulatory cells (Tregs); Interleukin 2; Interleukin-2

Summary:

      The reason for this study is to determine if the study drug LY3471851 is safe and effective
      in adult participants with active ulcerative colitis (UC). The study treatment will last
      about 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  Have evidence of UC extending proximal to the rectum (with ≥15 centimeters (cm) of
             involved colon).

          -  Have up-to-date colorectal cancer surveillance performed according to local standard.

          -  Participants are either one of the following:

          -  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,

          -  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.

          -  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.

          -  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.

        Exclusion Criteria:

          -  Have been diagnosed with indeterminant colitis, proctitis (colitis limited to the
             rectum only; less than 15 centimeter (cm) from the anal verge or Crohn's disease.

          -  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.

          -  Have had or will need abdominal surgery for UC (for example, subtotal colectomy).

          -  Have failed 3 or more classes of advanced therapies approved for treatment of UC (eg,
             tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40
             therapies, Janus kinase [JAK] inhibitor).

          -  Have evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis
             within the small bowel or colon.

          -  Have any history or evidence of cancer of the gastrointestinal tract

          -  Have myocardial infarction, unstable ischemic heart disease, stroke or heart failure
             within 12 months prior to screening.