BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:October 29, 2018
End Date:March 30, 2030
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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An Open Label, Long Term Safety Trial of BI 655130 Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials

To evaluate the long-term safety of BI 655130 in patients with moderate to severely active
ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term
efficacy of BI 655130 in patients with moderate to severely active ulcerative colitis, who
have completed treatment in previous trials


Inclusion Criteria:

- Male or female patients, aged ≥18 years

- Signed and dated written informed consent for 1368.17, in accordance with GCP and
local legislation prior to admission into the trial

- Women of childbearing potential (WOCBP) must be ready to use highly effective methods
of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per
year when used consistently and correctly. A list of contraception methods meeting
these criteria is provided in the patient information. Note: A woman is considered of
childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming
postmenopausal unless permanently sterile. Permanent sterilisation methods include
hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT
a method of permanent sterilisation. A postmenopausal state is defined as no menses
for 12 months without an alternative medical cause.

- Have completed treatment and the EOT visit in the previous trial and are willing and
able to continue treatment in 1368.17.

Exclusion Criteria:

- Have experienced study treatment-limiting adverse events during induction treatment
with study drug

- Have developed any of the exclusion criteria from the original induction study
We found this trial at
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Leuven, 3001
Phone: +32 16 34 88 56
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: +001 (615) 322-7403
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Hamden, Connecticut 06518
Phone: +001 (203) 281-5161
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New York, New York 10032
Phone: +001 (212) 831-4900
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Phone: +001 (407) 303-5503
Florida Hospital Florida Hospital is one of the country
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San Antonio, Texas 78229
Phone: +001 (210) 271-0606
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San Antonio, TX
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