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



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:March 27, 2018
End Date:May 30, 2021
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy

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.


Inclusion Criteria:

- 18 - 75 years, at date of signing informed consent, males or females

- Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and
endoscopic evidence corroborated by a histopathology report

- Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS
≥ 2 within 7-28 days prior to first dose)

- Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)

- Well-documented demonstration of inadequate response or loss of response or have had
unacceptable side effects with approved doses of TNFɑ agonists (infliximab,
adalimumab, golimumab) and/or vedolizumab in the past

- Further inclusion criteria apply

Exclusion Criteria:

- Evidence of abdominal abscess at screening

- Evidence of fulminant colitis or toxic megacolon at screening

- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

- Further exclusion criteria apply
We found this trial at
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11100 Euclid Ave
Cleveland, Ohio 44106
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201 Dowman Dr
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Chapel Hill, North Carolina 27599
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
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1200 Moursund Street
Houston, Texas 77030
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Miami, Florida 33124
(305) 284-2211
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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601 Elmwood Avenue
Rochester, New York 14642
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Decatur, Georgia 30033
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Great Neck, New York 11021
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Hamden, Connecticut 06518
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500 University Dr
Hershey, Pennsylvania 17033
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1428 Madison Ave
New York, New York 10029
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Norfolk, Virginia 23502
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
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601 E Rollins St
Orlando, Florida 32803
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660 S Euclid Ave
Saint Louis, Missouri 63110
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