Clinical trial NCT03100864: This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients
Official title: Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment With BI 655130 in Patients With Active Ulcerative Colitis (UC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC

Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment


Eligibility criteria: Inclusion Criteria:

* 18 - 75 years at screening
* Diagnosis of UC \>= 3 months prior to screening.
* Moderately to severely active UC as confirmed by Mayo Score ≥6
* Receiving conventional, non-biologic therapy for UC.
* Negative colon cancer screening
* Further inclusion criteria apply

Exclusion Criteria:

* Prior use of any biological treatment in the past (e.g.integrin inhibitors, IL12/23 or IL23 inhibitors, any investigational biological drugs)
* Extensive colonic resection
* Evidence of infection with C. difficile or other intestinal pathogen \< 30 days prior to screening
* Active or latent tuberculosis
* Further exclusion criteria apply

Primary outcomes:
measure: The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12
timeFrame: Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12).
Secondary outcomes:
measure: Percent Change in C-reactive Protein (CRP) From Baseline to Week 12
timeFrame: Measurements done at baseline (day -8 to -6) and week 12 (day 85).
measure: Percent Change in Faecal Calprotectin From Baseline to Week 12
timeFrame: Measurements done at baseline (day -8 to -6) and week 12 (day 85).
measure: Percent Change in Faecal Lactoferrin From Baseline to Week 12
timeFrame: Measurements done at baseline (day -8 to -6) and week 12 (day 85).
measure: Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12
timeFrame: Week 12 (day 85) following start of treatment.
measure: Number of Patients With Drug Related Adverse Events (AEs)
timeFrame: Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Hamburg
country: Germany
facility: Asklepios Kliniken Westklinikum Hamburg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
References: