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

An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) 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 (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

Study Overview

• Status: Completed
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Spesolimab IV infusion; Drug: Spesolimab SC solution for injection

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4010
    • Ordensklinikum Linz GmbH - Barmherzige Schwestern
  • Wien, Austria, 1090
    • AKH - Medical University of Vienna
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Victoria Hospital (LHSC)
• Germany
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Esslingen, Germany, 73730
    • Klinikum Esslingen GmbH
  • Hamburg, Germany, 22559
    • Asklepios Kliniken Westklinikum Hamburg
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Ulm, Germany, 89081
    • Universitatsklinikum Ulm
• Italy
  • Padova, Italy, 35128
    • Azienda Ospedaliera Universitaria di Padova
  • Rozzano (MI), Italy, 20089
    • Istituto Clinico Humanitas
• Japan
  • Hokkaido, Sapporo, Japan, 004-0041
    • Sapporo Tokushukai Hospital
  • Hokkaido, Sapporo, Japan, 065-0033
    • Sapporo Higashi Tokushukai Hospital
  • Hyogo, Nishinomiya, Japan, 663-8501
    • Hyogo College of Medicine Hospital
  • Kanagawa, Kamakura, Japan, 247-0056
    • Ofuna Chuo Hospital
  • Tokyo, Bunkyo-ku, Japan, 113-8519
    • Tokyo Medical and Dental University Hospital
  • Tokyo, Shinjuku, Japan, 169-0073
    • Tokyo Yamate Medical Center
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Paik Hospital
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Medical Center
• Poland
  • Warsaw, Poland, 02-507
    • National Medical Institute MSWiA
• Russian Federation
  • Irkutsk, Russian Federation, 664033
    • FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
  • Moscow, Russian Federation, 123423
    • Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
  • St. Petersburg, Russian Federation, 194044
    • Military Medical Academy n.a. C. M. Kirov, St. Petersburg
• Spain
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocío
  • Valencia, Spain, 46026
    • Hospital Politècnic La Fe
• United Kingdom
  • Doncaster, United Kingdom, DN2 5LT
    • Doncaster Royal Infirmary
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • Prescot, United Kingdom, L35 5DR
    • Whiston Hospital
• United States
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center-New York Presbyterian Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists Inc
  • Texas
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute, LLC
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants - Southlake
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Patients; 1 arm solution for injection Spesolimab will be used for all patients. Those who did not respond to previous induction treatment or experienced disease flare will need i.v. re-induction treatment also	Drug: Spesolimab IV infusion; Solution for infusion; Drug: Spesolimab SC solution for injection; Solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE)	Up to week 336

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with clinical remission	Up to 336 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 1368-0017; 2018-000334-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No