Phase 2
Completed N=8
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
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT03100864 ↗
Enrolled (actual)
8
Serious AEs
25.0%
Results posted
Nov 2020
Primary outcomePrimary: 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 — 3; 5; 2; 7 deregulated genes
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
3; 5; 2; 7; 9 | — |
| SECONDARY Percent Change in C-reactive Protein (CRP) From Baseline to Week 12 |
-79.6 | — |
| SECONDARY Percent Change in Faecal Calprotectin From Baseline to Week 12 |
13.0 | — |
| SECONDARY Percent Change in Faecal Lactoferrin From Baseline to Week 12 |
0.4 | — |
| SECONDARY Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12 |
— | — |
| SECONDARY Number of Patients With Drug Related Adverse Events (AEs) |
6 | — |
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
Data sourced from ClinicalTrials.gov (NCT03100864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.