A Placebo-controlled Study of a Targeted Immune Therapy Drug in Subjects with Moderate to Severe Ulcerative Colitis (UC)

Purpose

The primary objective of this study is to study the effectiveness of a novel targeted immune therapy (biologic) called LY3074828 in treating moderate to severe ulcerative colitis. This study will take place over 120 weeks and all study visits and procedures will be provided at no cost to you. During the initial part of this study, patients will either receive LY3074828, or placebo ("dummy" treatment). Patients who receive placebo initially will have the opportunity to receive the study drug LY3074828 later in the study.

Keywords: Colitis, Endoscopy, Corticosteroids

Study Sites

Keck School of Medicine, Los Angeles, USC 90033

 
  • Men & Women
Age icon
18-75
 
 
OR
 

What's involved?

Study length

  • 120 Weeks (2.5 Years)

Number of visits

  • 35-66 (varies)

Prescription

  • LY3074828, a targeted immune therapy (in Various Doses) or placebo

Procedures

  • Blood draws

  • Endoscopy and Intestinal Biopsy

  • Infusion

  • Chest X-rays

  • Electrocardiogram (ECG)

Compensation

  • Compensation will be provided to participants for each visit.

Medical cost coverage

  • The sponsor will provide the study drug (LY3074828), which is a targeted immune therapy, for all subjects throughout their participation in this trial.

  • All tests and procedures that participants will need for this study will be covered.

Why participate?

Medical advances are impossible without volunteers.

Eligibility

Must have

  • A moderate to severe active case of Ulcerative Colitis (UC)
  • Either been naive to biologic therapy or have at least one of the following: 1. Inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (e.g. 6-mercaptopurine or azathioprine) 2. A history of corticosteroid dependence OR participants must have received treatment with biologic therapy at doses approved for the treatment of UC but fail to respond or tolerate

Can't have

  • Been diagnosed with any of the following: Indeterminate Colitis, Proctitis (a distal diseases involving the rectum only; less than 15 cm from the anal verge), or Crohn's Disease.
  • Had surgery for treatment of UC or are likely to require surgery for UC during the study.
  • 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-aminosalicylic acid within 30 days of screening.

Study Team

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For questions about this study, contact:

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