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 |
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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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013099 |
E.1.2 | Term | Disease Crohns |
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 |
The objectives of this study are to determine the efficacy and safety of multiple doses of ABT-494 versus placebo and to assess the pharmacokinetics (PK) of ABT-494 following oral administration in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to anti-TNF therapy. |
Los objetivos de este estudio son determinar la eficacia y la seguridad de la administración reiterada de ABT-494 en comparación con placebo, y evaluar la farmacocinética (FC) de ABT-494 tras su administración por vía oral a pacientes con enfermedad de Crohn activa de intensidad moderada a grave con antecedentes de respuesta insuficiente al tratamiento anti-TNF o que no toleran el tratamiento. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male or female >= 18 and <=75 years of age at Baseline -Diagnosis of Crohn's disease (CD) for at least 90 days -CDAI >= 220 and <= 450 -Subject inadequately responded to or experience intolerance to previous treatment with an anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol). |
- Varones o mujeres de >=18 y <=75 años de edad en el momento basal. - Diagnóstico de enfermedad de Crohn, de al menos 90 dias. - CDAI >=220 y <=450 - La respuesta del paciente ha sido insuficiente o el paciente ha presentado intolerancia en el tratamiento previo con un anti-TNF (p. ej., infliximab, adalimumab o certolizumab pegol). |
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E.4 | Principal exclusion criteria |
-Subject with ulcerative colitis (UC), collagenous colitis or indeterminate colitis -Subject who has had surgical bowel resections in the past 6 months or is planning resection -Subjects with an ostomy or ileoanal pouch -Subject with bowel stricture or abdominal or peri-anal abcess -Subject who has short bowel syndrome -Subject with chronic recurring infections or active Tuberculosis (TB) |
-Pacientes con diagnóstico de colitis ulcerosa (CU), colitis colagenosa o colitis indeterminada. -Pacientes que se hayan sometido a una resección quirúrgica intestinal en los 6 últimos meses o que tengan previsto someterse a una. - Pacientes con ostomía o bolsa ileoanal - Paciente con estenosis intestinal o absceso abdominal o perianal. - Paciente con síndrome del intestino corto - Paciente con infección crónica recurrente , o con TB activa |
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E.5 End points |
E.5.1 | Primary end point(s) |
The co-primary endpoints are: -Proportion of subjects who achieve endoscopic remission at Week 12/16. -Proportion of subjects who achieve clinical remission at Week 16. |
-Proporción de pacientes que alcanzan la remisión endoscópica en la semana 12/16. - Proporción de pacientes que alcanzan la remisión clinica en la semana 16. |
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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) |
- Proportion of subjects who achieve CDAI < 150 at Week 16. - Proportion of subjects with decrease in CDAI >=70 points from Baseline at Week 16. - Proportion of subject who achieve remission at Week 52. |
-Proporción de pacientes que alcanzan un CDAI < 150 en la semana 16. - Proporción de pacientes con reducción de >= 70 puntos en el CDAI desde el momento basal hasta la semana 16 - Proporción de pacientes que alcanzan la remisión en la semana 52. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Duration of the study. |
Duración del estudio |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | 6 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 65 |
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 |
Australia |
Belgium |
Canada |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
Israel |
Italy |
Netherlands |
New Zealand |
Norway |
Poland |
Puerto Rico |
Romania |
Slovakia |
Spain |
Sweden |
United Kingdom |
United States |
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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
|
LSLV or the last follow-up contact, whichever is longer. |
UVUP o último contacto de seguimiento, lo que ocurra después. |
|
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 | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |