Last updated on July 2019

BI 655130 Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis


Brief description of study

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are

  • to prove the concept of clinical activity of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
  • to confirm efficacy and safety of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
  • To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Clinical Study Identifier: NCT03482635

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Whiston Hospital

Prescot, United Kingdom
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Center for Advanced GI

Maitland, FL United States
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CroNOLA, LLC

Houma, LA United States
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University of Miami

Miami, FL United States
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Emory University

Atlanta, GA United States
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Florida Hospital

Orlando, FL United States
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Digestive Disease Specialists Inc

Oklahoma City, OK United States
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Guy's Hospital

London, United Kingdom
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University of Chicago

Chicago, IL United States
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Guthrie Medical Group PC

Sayre, PA United States
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Barnsley Hospital

Barnsley, United Kingdom
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UZ Leuven

Leuven, Belgium
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Sameshima Hospital

Kagoshima, Kagoshima, Japan
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Doncaster Royal Infirmary

Doncaster, United Kingdom
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Severance Hospital

Seoul, Korea, Republic of
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AdventHealth Orlando

Orlando, FL United States
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Baylor College of Medicine

Houston, TX United States
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Sagact, Pllc

San Antonio, TX United States
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Kangbuk Samsung Hospital

Seoul, Korea, Republic of
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Recruitment Status: Open


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