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

Colitis, Ulcerative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648541
• Other study ID #: 1368-0017
• Secondary ID: 2018-000334-35
• Status: Completed
• Phase: Phase 2
• Start date: October 29, 2018
• Est. completion date: May 3, 2023

Study information

• Verified date: May 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 3, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Spesolimab IV infusion
Solution for infusion
• Spesolimab SC solution for injection
Solution for injection

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz GmbH - Barmherzige Schwestern	Linz
Austria	AKH - Medical University of Vienna	Wien
Belgium	UZ Leuven	Leuven
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Canada	Victoria Hospital (LHSC)	London	Ontario
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Klinikum Esslingen GmbH	Esslingen
Germany	Asklepios Kliniken Westklinikum Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Universitätsklinikum Ulm	Ulm
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
Italy	Istituto Clinico Humanitas	Rozzano (MI)
Japan	Sapporo Higashi Tokushukai Hospital	Hokkaido, Sapporo
Japan	Sapporo 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
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Yeungnam University Medical Center	Daegu
Poland	National Medical Institute MSWiA	Warsaw
Russian Federation	FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.	Irkutsk
Russian Federation	Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia	Moscow
Russian Federation	Military Medical Academy n.a. C. M. Kirov, St. Petersburg	St. Petersburg
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Politècnic La Fe	Valencia
United Kingdom	Doncaster Royal Infirmary	Doncaster
United Kingdom	Guy's Hospital	London
United Kingdom	Whiston Hospital	Prescot
United States	Emory University	Atlanta	Georgia
United States	University of Chicago	Chicago	Illinois
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
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	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	Southern Star Research Institute, LLC	San Antonio	Texas
United States	Texas Digestive Disease Consultants - Southlake	Southlake	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE)		Up to week 336
Secondary	Proportion of patients with clinical remission		Up to 336 weeks

External Links

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