E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy |
Colitis ulcerosa de ligera a moderadamente activa en terapia con inhibidores de TNF |
|
E.1.1.1 | Medical condition in easily understood language |
Ulcerative colitis |
Colitis ulcerosa |
|
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 | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
|
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 trial aims to prove the 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. |
Este ensayo pretende probar el concepto de inducción de la cicatrización de la mucosa mediante terapia adicional de BI 655130 en pacientes con colitis ulcerosa leve o moderada y actividad endoscópica persistente a pesar de tratamiento de inhibidores de TNF pre-existente. |
|
E.2.2 | Secondary objectives of the trial |
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 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. |
Este ensayo estudiará la eficacia y seguridad de una dosis de BI 655130 que demostró conseguir la misma exposición que las exposiciones más elevadas estudiadas y fue segura y tolerable en anteriores estudios de dosis única y múltiples en sujetos sanos como tratamiento adicional a tratamientos con inhibidores de TNF pre-existentes. Los objetivos secundarios inlcuyen la evaluacion del perfil farmacocinético de BI 655130 y la investigación temprana de biomarcadores con potencial utilidad para predecir la eficacia clínica o resultados de seguridad o ayudar a entender el modo de acción de BI 655130 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 18 – 60 years at screening and randomisation - Diagnosis of ulcerative colitis ≥4 months prior to screening - ReceivingTNFi treatment with doses unchanged for ≥4 months prior to randomisation - Mild or moderate disease activity, defined as total Mayo Score (MCS) (≤10) - Further criteria apply |
- Entre 18 y 60 años en el momento de la selección y aleatorización - Diagnóstico de colitis ulcerosa en los últimos 4 meses - Recibir tratamiento con inhibidores de TNF con dosis constantes en los últimos 4 meses antes de la aleatorización - Actividad ligera o moderada de la enfermedad, definida como resultado total de Mayo (MCS) (menor o igual a 10) - Otros criterios son aplicables |
|
E.4 | Principal exclusion criteria |
- Prior use of more than one different TNF inhibitor 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 criteria apply |
- Previo uso de más de un distinto inhibidor de TNF o vedolizumab - Resección extensa del colon - Evidencias de infección con C.difficile u otro patógeno intestinal al menos 28 días antes de la selección - Tuberculosis activa o latente - Otros criterios son aplicables |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1) Mucosal healing (MCS mESS ≤1) |
1) Cicatrización de la mucosa (MCS mESS menor o igual a 1) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) Clinical remission based on Mayo score (total MCS ≤2 points, and all subscores ≤1 point) 2) Histological remission (Robarts (RHI) score ≤6) 3) Clinical remission based on Mayo score (total MCS ≤2 points, and all subscores ≤1 point) 4) Mucosal healing (MCS mESS ≤1) 5) Histological remission (Robarts (RHI) score ≤6) 6) Modified clinical remission based on Mayo score (total modified MCS ≤2 and: RBS=0, Stool Frequency Score (SFS) =0 or 1 and drop ≥1 from baseline, AND mESS ≤1) 7) Modified clinical remission based on Mayo score (total modified MCS ≤2 and: RBS=0, SFS =0 or 1 and drop ≥1 from baseline, AND mESS ≤1) |
1) Remisión clínica basada en el resultado Mayo (MCS total menor o igual a 2 puntos, y todos los subresultados menores o iguales a 1 punto) 2)Remisión histológica (resultado de Robarts (RHI) menor o igual a 6) 3)Remisión clínica basada en el resultado Mayo (MCS total menor o igual a 2 puntos, y todos los subresultados menores o iguales a 1 punto) 4)Cicatrización de la mucosa (MCS mESS menor o igual a 1) 5)Remisión histológica (resultado de Robarts (RHI) menor o igual a 6) 6) Remisión clínica modificada basada en el resultado Mayo (total modificado MCS menor o igual a 2 y: RBS=0, Resultado de Frecuencia de Deposiciones (SFS) = 0 o 1 y descenso mayor o igual a 1 del estado basal, y mESS menor o igual a 1) 7)Remisión clínica modificada basada en el resultado Mayo (total modificado MCS menor o igual a 2 y: RBS=0, (SFS) = 0 o 1 y descenso mayor o igual a 1 desde periodo basal, y mESS menor o igual a 1) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 8 weeks 2) 8 weeks 3) 12 weeks 4) 12 weeks 5) 12 weeks 6) 8 weeks 7) 12 weeks |
1) 8 semanas 2) 8 semanas 3) 12 semanas 4) 12 semanas 5) 12 semanas 6) 8 semanas 7) 12 semanas |
|
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 | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
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 | Yes |
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
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 20 |
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 | 15 |