BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
- Registration Number
- NCT03648541
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To evaluate the long-term safety of BI 655130 (SPESOLIMAB) 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 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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.
-
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 with the following exceptions:
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spesolimab IV infusion Spesolimab Spesolimab IV infusion Spesolimab SC solution for injection Spesolimab Spesolimab SC solution for injection
- Primary Outcome Measures
Name Time Method Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE) From first maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days. Exposure adjusted rate of participants reporting a treatment emergent adverse event (TEAE).
The exposure adjusted incidence rate (per 100 subject years) of a selected treatment emergent adverse event is defined as the number of subjects experiencing the adverse event per treatment group during time at risk divided by the total time of subjects at risk in that treatment group to contribute the event to the analysis multiplied by 100 (per 100 subject years).
Only participants receiving maintenance treatment were analysed for this endpoint.
- Secondary Outcome Measures
Name Time Method Proportion of Patients With Clinical Remission at Week 336 of Maintenance Treatment Up to 336 weeks Proportion of patients with clinical remission at Week 336 of maintenance treatment. Clinical remission was defined as rectal bleeding score (RBS) = 0, modified endoscopic subscore \[mESS\] ≤1, stool frequency score (SFS) = 0 or 1 and drop ≥1 from baseline, and modified mayo clinical score ((MCS) ≤2).
Trial Locations
- Locations (38)
Emory University
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Southern Star Research Institute, LLC
🇺🇸San Antonio, Texas, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Ordensklinikum Linz GmbH - Barmherzige Schwestern
🇦🇹Linz, Austria
Victoria Hospital (LHSC)
🇨🇦London, Ontario, Canada
AKH - Medical University of Vienna
🇦🇹Wien, Austria
UZ Leuven
🇧🇪Leuven, Belgium
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Asklepios Kliniken Westklinikum Hamburg
🇩🇪Hamburg, Germany
Tokyo Medical and Dental University Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Doncaster Royal Infirmary
🇬🇧Doncaster, United Kingdom
Columbia University Medical Center-New York Presbyterian Hospital
🇺🇸New York, New York, United States
Texas Digestive Disease Consultants - Southlake
🇺🇸Southlake, Texas, United States
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
Klinikum Esslingen GmbH
🇩🇪Esslingen, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Azienda Ospedaliera Universitaria di Padova
🇮🇹Padova, Italy
Hyogo College of Medicine Hospital
🇯🇵Hyogo, Nishinomiya, Japan
Tokyo Yamate Medical Center
🇯🇵Tokyo, Shinjuku, Japan
Sapporo Tokushukai Hospital
🇯🇵Hokkaido, Sapporo, Japan
Ofuna Chuo Hospital
🇯🇵Kanagawa, Kamakura, Japan
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Italy
Sapporo Higashi Tokushukai Hospital
🇯🇵Hokkaido, Sapporo, Japan
FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
🇷🇺Irkutsk, Russian Federation
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Military Medical Academy n.a. C. M. Kirov, St. Petersburg
🇷🇺St. Petersburg, Russian Federation
Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
🇷🇺Moscow, Russian Federation
Hospital Politècnic La Fe
🇪🇸Valencia, Spain
Whiston Hospital
🇬🇧Prescot, United Kingdom
National Medical Institute MSWiA
🇵🇱Warsaw, Poland
Digestive Disease Specialists Inc
🇺🇸Oklahoma City, Oklahoma, United States
Hunter Holmes McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Guy's Hospital
🇬🇧London, United Kingdom