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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03648541
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Belgium, Canada, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Study Website: View Trial Website
Arms & Interventions

Arms

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

Interventions

Drug: - Spesolimab IV infusion

Solution for infusion

Drug: - Spesolimab SC solution for injection

Solution for injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hamden, Connecticut

Status

Completed

Address

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518

Emory University, Atlanta, Georgia

Status

Completed

Address

Emory University

Atlanta, Georgia, 30322

University of Chicago, Chicago, Illinois

Status

Completed

Address

University of Chicago

Chicago, Illinois, 60637

New York, New York

Status

Completed

Address

Columbia University Medical Center-New York Presbyterian Hospital

New York, New York, 10032

Digestive Disease Specialists Inc, Oklahoma City, Oklahoma

Status

Active, not recruiting

Address

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73112

Southern Star Research Institute, LLC, San Antonio, Texas

Status

Completed

Address

Southern Star Research Institute, LLC

San Antonio, Texas, 78229

Southlake, Texas

Status

Active, not recruiting

Address

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, 76092

Hunter Holmes McGuire VA Medical Center, Richmond, Virginia

Status

Completed

Address

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249

International Sites

Linz, Austria

Status

Active, not recruiting

Address

Ordensklinikum Linz GmbH - Barmherzige Schwestern

Linz, , 4010

AKH - Medical University of Vienna, Wien, Austria

Status

Active, not recruiting

Address

AKH - Medical University of Vienna

Wien, , 1090

UZ Leuven, Leuven, Belgium

Status

Completed

Address

UZ Leuven

Leuven, , 3000

Liège, Belgium

Status

Completed

Address

Centre Hospitalier Universitaire de Liège

Liège, , 4000

Victoria Hospital (LHSC), London, Ontario, Canada

Status

Completed

Address

Victoria Hospital (LHSC)

London, Ontario, N6A 5W9

Universitätsklinikum Erlangen, Erlangen, Germany

Status

Completed

Address

Universitätsklinikum Erlangen

Erlangen, , 91054

Klinikum Esslingen GmbH, Esslingen, Germany

Status

Completed

Address

Klinikum Esslingen GmbH

Esslingen, , 73730

Asklepios Kliniken Westklinikum Hamburg, Hamburg, Germany

Status

Completed

Address

Asklepios Kliniken Westklinikum Hamburg

Hamburg, , 22559

Medizinische Hochschule Hannover, Hannover, Germany

Status

Completed

Address

Medizinische Hochschule Hannover

Hannover, , 30625

Kiel, Germany

Status

Active, not recruiting

Address

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , 24105

Universitätsklinikum Ulm, Ulm, Germany

Status

Active, not recruiting

Address

Universitätsklinikum Ulm

Ulm, , 89081

Padova, Italy

Status

Completed

Address

Azienda Ospedaliera Universitaria di Padova

Padova, , 35128

Istituto Clinico Humanitas, Rozzano (MI), Italy

Status

Completed

Address

Istituto Clinico Humanitas

Rozzano (MI), , 20089

Sapporo Tokushukai Hospital, Hokkaido, Sapporo, Japan

Status

Recruiting

Address

Sapporo Tokushukai Hospital

Hokkaido, Sapporo, , 004-0041

Site Contact

Toshifumi Ashida

ashida-sapporo@tmc-sp.org

+81 11 8901110

Sapporo Higashi Tokushukai Hospital, Hokkaido, Sapporo, Japan

Status

Recruiting

Address

Sapporo Higashi Tokushukai Hospital

Hokkaido, Sapporo, , 065-0033

Site Contact

Atsuo Maemoto

maemoto@tohtoku.jp

+81 11 7221110

Hyogo College of Medicine Hospital, Hyogo, Nishinomiya, Japan

Status

Recruiting

Address

Hyogo College of Medicine Hospital

Hyogo, Nishinomiya, , 663-8501

Site Contact

Yoko Yokoyama

yoko0502@hyo-med.ac.jp

+81 798 456111

Ofuna Chuo Hospital, Kanagawa, Kamakura, Japan

Status

Recruiting

Address

Ofuna Chuo Hospital

Kanagawa, Kamakura, , 247-0056

Site Contact

Yutaka Endo

y_endo2014@yahoo.co.jp

+81 467 452111

Tokyo Medical and Dental University, Tokyo, Bunkyo-ku, Japan

Status

Recruiting

Address

Tokyo Medical and Dental University

Tokyo, Bunkyo-ku, , 113-8519

Site Contact

Toshimitsu Fujii

tfujgast@tmd.ac.jp

+81 3 38136111

Tokyo Yamate Medical Center, Tokyo, Shinjuku, Japan

Status

Completed

Address

Tokyo Yamate Medical Center

Tokyo, Shinjuku, , 169-0073

Inje University Haeundae Paik Hospital, Busan, Korea, Republic of

Status

Completed

Address

Inje University Haeundae Paik Hospital

Busan, , 48108

Yeungnam University Medical Center, Daegu, Korea, Republic of

Status

Completed

Address

Yeungnam University Medical Center

Daegu, , 42415

Warsaw, Poland

Status

Active, not recruiting

Address

Central Clinical Hospital MSWiA, Internal Diseases, Warsaw

Warsaw, , 02-507

Irkutsk, Russian Federation

Status

Completed

Address

FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.

Irkutsk, , 664033

Moscow, Russian Federation

Status

Completed

Address

Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia

Moscow, , 123423

St. Petersburg, Russian Federation

Status

Active, not recruiting

Address

Military Medical Academy n.a. C. M. Kirov, St. Petersburg

St. Petersburg, , 194044

Hospital Virgen del Rocío, Sevilla, Spain

Status

Completed

Address

Hospital Virgen del Rocío

Sevilla, , 41013

Hospital Politècnic La Fe, Valencia, Spain

Status

Completed

Address

Hospital Politècnic La Fe

Valencia, , 46026

Doncaster Royal Infirmary, Doncaster, United Kingdom

Status

Completed

Address

Doncaster Royal Infirmary

Doncaster, , DN2 5LT

Guy's Hospital, London, United Kingdom

Status

Completed

Address

Guy's Hospital

London, , SE1 9RT

Whiston Hospital, Prescot, United Kingdom

Status

Active, not recruiting

Address

Whiston Hospital

Prescot, , L35 5DR

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