BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
NCT ID: NCT03648541
Last Updated: 2025-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2018-10-29
2023-05-03
Brief Summary
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To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Spesolimab IV infusion
Spesolimab IV infusion
Spesolimab
Solution
Spesolimab SC solution for injection
Spesolimab SC solution for injection
Spesolimab
Solution
Interventions
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Spesolimab
Solution
Eligibility Criteria
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Inclusion Criteria
* 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
* Cases of disease limited to the rectum extending \<15 cm past the anal verge are allowed to be included in study 1368.17
* Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Ordensklinikum Linz GmbH - Barmherzige Schwestern
Linz, , Austria
AKH - Medical University of Vienna
Vienna, , Austria
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Victoria Hospital (LHSC)
London, Ontario, Canada
Universitätsklinikum Erlangen
Erlangen, , Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, , Germany
Asklepios Kliniken Westklinikum Hamburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Istituto Clinico Humanitas
Rozzano (MI), , Italy
Sapporo Tokushukai Hospital
Hokkaido, Sapporo, , Japan
Sapporo Higashi Tokushukai Hospital
Hokkaido, Sapporo, , Japan
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, , Japan
Ofuna Chuo Hospital
Kanagawa, Kamakura, , Japan
Tokyo Medical and Dental University Hospital
Tokyo, Bunkyo-ku, , Japan
Tokyo Yamate Medical Center
Tokyo, Shinjuku, , Japan
National Medical Institute MSWiA
Warsaw, , Poland
FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
Irkutsk, , Russia
Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
Moscow, , Russia
Military Medical Academy n.a. C. M. Kirov, St. Petersburg
Saint Petersburg, , Russia
Inje University Haeundae Paik Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Hospital Virgen del Rocío
Seville, , Spain
Hospital Politècnic La Fe
Valencia, , Spain
Doncaster Royal Infirmary
Doncaster, , United Kingdom
Guy's Hospital
London, , United Kingdom
Whiston Hospital
Prescot, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2018-000334-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1368-0017
Identifier Type: -
Identifier Source: org_study_id
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