A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT04677179

Run by

Nektar Therapeutics

People needed

81

Starts

2021-03-22

Expected to finish

2022-08-09

Last updated by the study team

2023-09-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• I.H.S. Health, LLC — Kissimmee, Florida, United States
• Gastroenterology Associates of Pensacola, PA — Pensacola, Florida, United States
• Atlantic Digestive Health Institute — Morristown, New Jersey, United States
• Biopharma Informatic, LLC — Houston, Texas, United States
• Southern Star Research Institute, LLC — San Antonio, Texas, United States
• Care Access Research - Ogden — Ogden, Utah, United States
• DOM- Centro de Reumatologia — CABA, Buenos Aires, Argentina
• Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC — CABA, Buenos Aires, Argentina
• Mautalen Salud e Investigacion-Centro de Osteopatías Médicas — Ciudad Autonoma de Buenos Air, Buenos Aires, Argentina
• Centro Médico Privado de Reumatología — San Miguel de Tucumán, Argentina
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• Paratus Clinical Research Brisbane — Albion, Queensland, Australia
• Mater Adult Hospital Brisbane — South Brisbane, Queensland, Australia
• St. Vincent's Hospital — Fitzroy, Victoria, Australia
• Université Libre de Bruxelles - Hôpital Erasme — Brussels, Bruxelles-Capitale, Région de, Belgium
• Centre Hospitalier de Wallonie Picarde - Site Notre Dame — Tournai, Wallonne, Région, Belgium
• AZ Maria Middelares — Ghent, Belgium
• Chronos Pesquisa Clínica — Brasília, Federal District, Brazil
• Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS — Porto Alegre, Rio Grande do Sul, Brazil
• Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP — Botucatu, São Paulo, Brazil
• HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas — Campinas, São Paulo, Brazil
• Pesquisare — Santo André, São Paulo, Brazil
• CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda — São Bernardo do Campo, São Paulo, Brazil
• Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual — São Paulo, São Paulo, Brazil
• Dedicated Clinical Research — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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