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

Completed · Phase 2

Conditions studied: Colitis, Ulcerative

In brief

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

Key facts

Study ID

NCT03648541

Run by

Boehringer Ingelheim

People needed

79

Starts

2018-10-29

Expected to finish

2023-05-03

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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 — Padova, 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

Full record on ClinicalTrials.gov

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