E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active ulcerative colitis |
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E.1.1.1 | Medical condition in easily understood language |
Inflammatory Bowel Disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This trials aims to understand the mechanism of action of BI655130 in patients with ulcerative colitis (UC) |
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E.2.2 | Secondary objectives of the trial |
Explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 18 – 65 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
- Naive or experienced to TNF antagonists (but have not failed that treatment due to primary non-response or loss of response) |
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E.4 | Principal exclusion criteria |
-Patients who have previously failed treatment with any TNF antagonist due to primary non-response or loss of response
- Prior use of any other biological treatment in the past (e.g. integrin inhibitors, IL12/23 or IL23 inhibitors , any other 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
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|
E.5 End points |
E.5.1 | Primary end point(s) |
1) The total number of deregulated genes comparing baseline to post-treatment, analysed by gene expression of mucosal biopsies via RNA sequencing (RNAseq) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Drug related AEs
2) Percent change in CRP
3) Percent change in faecal calprotectin
4) Percent change in faecal lactoferrin
5) Clinical remission based on Mayo Score (Mayo Score ≤2 with all subscores ≤1)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 12 weeks
2) 12 weeks
3) 12 weeks
4) 12 weeks
5) 12 weeks
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 7 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 7 |