BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
NCT ID: NCT03482635
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
98 participants
INTERVENTIONAL
2018-03-27
2020-05-18
Brief Summary
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* to prove the concept of clinical activity of BI655130 (SPESOLIMAB) 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 BI655130 (SPESOLIMAB) 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1- Placebo Group
Placebo
Solution for infusion
Group 2- Small Dose Group
Spesolimab
Solution for infusion
Group 3- Medium Dose Group
Spesolimab
Solution for infusion
Group 4 - High Dose Group
Spesolimab
Solution for infusion
Interventions
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Spesolimab
Solution for infusion
Placebo
Solution for infusion
Eligibility Criteria
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Inclusion Criteria
* 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 antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
Exclusion Criteria
* Evidence of fulminant colitis or toxic megacolon at screening
* Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
18 Years
75 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
University of Miami
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
Baylor College of Medicine
Houston, Texas, 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
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba, Canada
Victoria Hospital (LHSC)
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Universitätsklinikum Aachen, AöR
Aachen, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen AöR
Essen, , Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, , 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
Toho University Sakura Medical Center
Chiba, Sakura, , Japan
Sapporo Tokushukai Hospital
Hokkaido, Sapporo, , Japan
Sapporo Higashi Tokushukai Hospital
Hokkaido, Sapporo, , Japan
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, , Japan
Sameshima Hospital
Kagoshima, Kagoshima, , Japan
Ofuna Chuo Hospital
Kanagawa, Kamakura, , Japan
Tokyo Medical and Dental University
Tokyo, Bunkyo-ku, , Japan
Kitasato Institute Hospital
Tokyo, Minato-ku, , Japan
Tokyo Yamate Medical Center
Tokyo, Shinjuku, , Japan
Health Center of Mother, Child and Youth Sp.z o.o.
Warsaw, , Poland
Central Clinical Hospital MSWiA, Internal Diseases, Warsaw
Warsaw, , Poland
FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
Irkutsk, , Russia
Kirov State Med.Univ. of MoH RF
Kirov, , Russia
Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
Moscow, , Russia
Reg. Clin. Scientific Research Institute na Vladimiskiy
Moscow, , Russia
The limited liability company "Clinic USI 4D"
Pyatigorsk, , Russia
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"
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
Barnsley Hospital
Barnsley, , United Kingdom
Doncaster Royal Infirmary
Doncaster, , United Kingdom
Guy's Hospital
London, , United Kingdom
Whiston Hospital
Prescot, , United Kingdom
Countries
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References
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Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available.
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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2017-004230-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1368-0005
Identifier Type: -
Identifier Source: org_study_id
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