Clinical trial NCT03123120: 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
Official title: Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 (Infliximab) or \>= 2 Monaten (Adalimumab or Golimumab) 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

Primary outcomes:
measure: Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12
timeFrame: At Week 12
measure: Proportion of Participants With Histological Remission at Week 12
timeFrame: At Week 12
measure: Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12
timeFrame: At Week 12
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From first does of study medication until end of the follow-up period, up to 36 weeks.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Sygehus Syd
city: Herlev
country: Denmark
facility: Sanos Clinic
city: Odense
country: Denmark
facility: Odense University Hospital
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie AMC
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus HF
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Politècnic La Fe
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: Prescot
country: United Kingdom
facility: Whiston Hospital
Study officials:
References: