Phase 2
Completed N=22
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
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT03123120 ↗
Enrolled (actual)
22
Serious AEs
13.6%
Results posted
Oct 2021
Primary outcomePrimary: Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12 — 0.375; 0.143 Proportion of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12 |
0.375; 0.143 | — |
| SECONDARY Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12 |
0.125; 0.071 | — |
| SECONDARY Proportion of Participants With Histological Remission at Week 12 |
0.500; 0.214 | — |
| SECONDARY Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12 |
0.000; 0.143 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
6; 15 | — |
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
Data sourced from ClinicalTrials.gov (NCT03123120). 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.