A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

Study Purpose

The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment. This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130`s mode of action.

Recruitment Criteria

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

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria

  • - 18 - 75 years at screening and randomisation - Diagnosis of ulcerative colitis >= 5 months prior to screening - Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for >= 4 months prior to randomisation - Mild or moderate disease activity, defined as total Mayo Score (MCS) (<= 10) - Further inclusion criteria apply

    Exclusion Criteria:

    - Prior use of more than two different TNF inhibitors or vedolizumab - Extensive colonic resection - Evidence of infection with C.
difficile or other intestinal pathogen <28 days prior to screening - Active or latent tuberculosis - Further exclusion criteria apply

Trial Details

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.

Trial ID:
NCT03123120

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
Phase 2

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

Lead Sponsor
Boehringer Ingelheim

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

Principal Investigator
N/A
Principal Investigator Affiliation N/A

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

Agency Class
Industry
Overall Status Recruiting
Countries Denmark, Germany, Ireland, Netherlands, Norway, Spain, United Kingdom

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

Conditions
Colitis, Ulcerative

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.

International Sites

Guy's Hospital, London, United Kingdom

Status

Recruiting

Address

Guy's Hospital

London, , SE1 9RT

Site Contact

Peter Irving

peter.irving@gstt.nhs.uk

02071882499

St James's University Hospital, Leeds, United Kingdom

Status

Recruiting

Address

St James's University Hospital

Leeds, , LS9 7TF

Site Contact

Christian Selinger

Christian.selinger@nhs.net

0113 206 7549

Addenbrooke's Hospital, Cambridge, United Kingdom

Status

Recruiting

Address

Addenbrooke's Hospital

Cambridge, , CB2 0QQ

Site Contact

Arthur Kaser

ak729@cam.ac.uk

01223768308

Zaragoza, Spain

Status

Recruiting

Address

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , 50009

Site Contact

Fernando Gomollón García

fgomollon@gmail.com

+34976765700 ext.162012

Hospital Politècnic La Fe, Valencia, Spain

Status

Recruiting

Address

Hospital Politècnic La Fe

Valencia, , 46026

Site Contact

Belén Beltrán Niclos

belenbeltranniclos@gmail.com

+34961244000

Santander, Spain

Status

Recruiting

Address

Hospital Universitario Marqués de Valdecilla

Santander, , 39008

Site Contact

Montserrat Rivero

digrtm@humv.es

+34942203565

Hospital Puerta de Hierro, Majadahonda, Spain

Status

Recruiting

Address

Hospital Puerta de Hierro

Majadahonda, , 28222

Site Contact

Isabel Vera Mendoza

isabel.veramendoza@gmail.com

+34911916000

Akershus Universitetssykehus HF, Lørenskog, Norway

Status

Recruiting

Address

Akershus Universitetssykehus HF

Lørenskog, , N-1478

Site Contact

Jørgen Jahnsen

jorgen.jahnsen@medisin.uio.no

+47 67966013

Academisch Medisch Centrum (AMC), Amsterdam, Netherlands

Status

Recruiting

Address

Academisch Medisch Centrum (AMC)

Amsterdam, , 1105 AZ

Site Contact

Geert D'Haens

g.dhaens@amc.uva.nl

+31 (0)20 566 3534

St Vincent's University Hospital, Dublin 4, Ireland

Status

Recruiting

Address

St Vincent's University Hospital

Dublin 4, , D04 T6F4

Site Contact

Glen Doherty

g.doherty@st-vincents.ie

35312214711

Universitätsklinikum Ulm, Ulm, Germany

Status

Recruiting

Address

Universitätsklinikum Ulm

Ulm, , 89081

Kiel, Germany

Status

Recruiting

Address

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , 24105

Site Contact

Stefan Schreiber

s.schreiber@mucosa.de

+49 (431) 50015101

Medizinische Hochschule Hannover, Hannover, Germany

Status

Recruiting

Address

Medizinische Hochschule Hannover

Hannover, , 30625

Site Contact

Ursula Seidler

Seidler.Ursula@MH-Hannover.de

+49 (511) 5329427

Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

Status

Recruiting

Address

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , 20246

Site Contact

Samuel Huber

shuber@uke.de

+49 (40) 7410-57273

Universitätsklinikum Freiburg, Freiburg, Germany

Status

Recruiting

Address

Universitätsklinikum Freiburg

Freiburg, , 79106

Universitätsklinikum Erlangen, Erlangen, Germany

Status

Recruiting

Address

Universitätsklinikum Erlangen

Erlangen, , 91054

Odense Universitetshospital, Odense, Denmark

Status

Recruiting

Address

Odense Universitetshospital

Odense, , 5000

Site Contact

Jens Kjeldsen

jens.kjeldsen@rsyd.dk

+45 65415986

Sanos Clinic, Herlev, Denmark

Status

Recruiting

Address

Sanos Clinic

Herlev, , 2730

Site Contact

Henning Nielsen

hbn@sanosclinic.com

+4573708203

Aalborg Sygehus Syd, Aalborg, Denmark

Status

Recruiting

Address

Aalborg Sygehus Syd

Aalborg, , 9100

Site Contact

Jan Fallingborg

jaf@rn.dk

+45 97663560

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