E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crohn's disease |
Enfermedad de Crohn |
|
E.1.1.1 | Medical condition in easily understood language |
Crohn's disease |
Enfermedad de Crohn |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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 |
To evaluate efficacy of BI 655066 in inducing clinical remission, defined as CDAI [Crohn's Disease Activity Index] <150 after 12 weeks of treatment. |
Evaluar la eficacia de BI 655066 en la inducción de la remisión clínica, definida como CDAI<150 después de 12 semanas de tratamiento. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate efficacy, safety and pharmacokinetics of BI 655066 therapy in Crohn's disease. |
Evaluar la eficacia, seguridad y farmacocinética del tratamiento con BI 655066 en la enfermedad de Crohn. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men or women 18-75 years at the time of consent. - Diagnosis of Crohn's disease at least 3 months prior to screening. - Moderate to severe active Crohn's disease, defined as CDAI >or=220 and <or=450. |
- Hombres o mujeres entre los 18 y 75 años (inclusive) en el momento del consentimiento. - Diagnóstico de enfermedad de Crohn durante los últimos 3 meses, como mínimo, antes de la visita 1 - Enfermedad de Crohn activa de moderada a grave, definida como CDAI ?220 y ?450. |
|
E.4 | Principal exclusion criteria |
- Complications of Crohn's disease such as strictures, stenoses, short gut syndrome, or any other manifestation that might require surgery. - Presence of ileostomy or colostomy. - Pregnant or nursing women. - Signs or symptoms suggestive of active TB. - History of malignancy. |
- Complicaciones de la enfermedad de Crohn como estrechamiento, estenosis, síndrome del intestino corto o cualquier otra manifestación que pueda requerir intervención quirúrgica. - Se excluye a los pacientes con ileostomía o colostomía. - Mujeres embarazadas o en periodo de lactancia - Indicios o síntomas que sugieran una TB activa - Historia de enfermedad maligna |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1: Proportion of patients achieving clinical remission at week 12, defined as a CDAI score of < 150. |
1: Proporción de pacientes que alcanzan la remisión clínica en la semana 12, definida por una puntuación CDAI <150. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1: Proportion of patients achieving clinical response defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points.
2: Proportion of patients achieving CDEIS remission, defined as a score of 4 or less.
3: Proportion of patients achieving CDEIS response, defined as a score of 7 or less.
4: Proportion of patients achieving mucosal healing, defined as the absence of mucosal ulceration.
5: Proportion of patients achieving deep remission, defined as clinical remission and CDEIS remission.
6: Proportion of patients achieving reduction of 75% in CDEIS scores from baseline.
7: Time to flare for patients who achieve deep remission.
8: Factors associated with clinical remission (for those that failed to achieve deep remission at week 12).
9: Time to CDAI >or= 150 for those who achieve clinical remission at Week 26. |
1: Proporción de pacientes que alcanzan respuesta clínica definida o por una puntuación CDAI de < 150 o por una reducción CDAI respecto al valor basal de cómo mínimo 100 puntos. 2: Proporción de pacientes que alcanzan una remisión CDEIS, definida como una puntuación de 4 o inferior. 3: Proporción de pacientes que alcanzan una respuesta CDEIS, definida como una puntuación de 7 o inferior. 4: Proporción de pacientes que alzancan curación mucosa, definida como la ausencia de una ulceración de la mucosa. 5: Proporción de pacientes que alcanzan una remisión profunda, definida como remisión clínica y remisión CDEIS. 6: Proporción de pacientes que alcanzan una reducción del 75% en la puntuación CDEIS respecto al valor basal. 7: Tiempo hasta el brote para los pacientes que logren una remisión profunda. 8: Factores asociados a una remisión clínica (para los pacientes que no logren una remisión profunda en la semana 12). 9: Tiempo hasta CDAI >= 150 para los pacientes que logren una remisión clínica en la semana 26. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: week 12
2: week 12
3: week 12
4: week 12
5: week 12
6: week 12
7: week 65
8: week 65
9: week 65 |
1: semana 12
2: semana 12
3: semana 12
4: semana 12
5: semana 12
6: semana 12
7: semana 65
8: semana 65
9: semana 65 |
|
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 | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Canada |
France |
Ireland |
Netherlands |
Korea, Republic of |
Spain |
United Kingdom |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 20 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 20 |