E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with moderately to severely active Crohn's disease |
Pacientes con Enfermedad de Crohn activada de moderada a grave |
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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] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 primary objective of the study is to assess the efficacy, safety, and tolerability of ABBV 154 in comparison with placebo in subjects with moderately to severely active CD who had inadequate response to or were intolerant of prior biologics. |
El objetivo primario de este estudio es evaluar la eficacia, seguridad y tolerabilidad de ABBV-154 en comparación con placebo en pacientes con enfermedad de Crohn activada de moderada a severa y respuesta inadecuada o intolerancia a biológicos previos. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ABBV 154. |
El objetivo secundario es evaluar la farmacocinética (FC), farmacodinamia (PD) e inmunogenicidad de ABBV-154. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female between 18 and 75 years of age inclusive at the time of Screening. 2. Confirmed diagnosis of CD for at least 3 months prior to Baseline of the Induction Period. 3. CDAI score 220 to 450 at Baseline of the Induction Period. 4. Endoscopic evidence of mucosal inflammation as documented by an SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component. 5. Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, or ustekinumab. |
1. Hombres o Mujeres entre 18 y 15 años en el momento de la selección. 2. EC confirmada al menos 3 meses antes de la visita basal de la inducción. 3. Puntuación CDAI 220 a 450 en la visita basal del periodo de inducción. 4. Evidencia endoscópica de la inflamación de la mucosa documentado como SES CD de ≥6 para enfermedad colónica o ileocolónica o SES-CD≥ 4 para enfermedad ileal aislada puntuada por el lector central. Todas las puntuaciones elegibles deben excluir la presencia del componente de estrechamiento. 5. Intolerancia o respuesta inadecuada demostrada a uno o más agentes biológicos: Infliximab, Adalimumab, Certolizumab-Pegol, Vedolizumab, Natalizumab o Ustekimuzbab. |
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E.4 | Principal exclusion criteria |
1. Subjects with prior intolerance to adalimumab are not eligible to enroll. 2. Subjects who discontinued biologic agents only for reasons other than inadequate response or intolerance (e.g., change of insurance) are not eligible to enroll. |
1. Pacientes con intolerancia previa a adalimumab no son elegibles para el estudio. 2.Pacientes que discontinuaron a agentes biológicos por razones distintas diferentes a respuesta inadecuada o intolerancia (Ej. Cambio en el seguro) no son elegibles para incluir. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the achievement of endoscopic response at Week 12 in the Induction Period defined as a decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD17) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). |
El objetivo principal es la mejora en la respuesta endoscópica en la semana 12 en el periodo de inducción definido como un descenso en la puntuación endoscópica simple para la enfermedad de Crohn (SES-CD17) > 50% desde la visita basal (o pacientes con enfermedad ileal aislada y un SES CD de 4 en la visita basal que tuvieron una reducción de al menos 2 puntos desde la visita basal). |
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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) |
• Achievement of clinical remission per Crohn’s Disease Activity Index (CDAI) at Week 12 in the Induction Period defined as CDAI < 150. • Achievement of clinical remission per average daily liquid or very soft stool frequency (SF) and average daily abdominal pain (AP) score (SF/AP) at Week 12 in the Induction Period defined as average daily liquid or very soft SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline. • Achievement of endoscopic response per SES-CD at Week 40 in the Maintenance Period. • Achievement of clinical remission per CDAI at Week 40 in the Maintenance Period. • Achievement of clinical remission per SF/AP at Week 40 in the Maintenance Period. |
• Alcanzar la remisión clínica por el índice de Actividad de la Enfermedad de Crohn (CDAI) en la semana 12 del periodo de inducción definido por un CDAI<150 • Alcanzar remisión clínica para la frecuencia media de heces líquidas o muy blandas y la puntuación media diaria de dolor abdominal (AP) en semana 12 del periodo de inducción definido como una media de heces líquidas o muy líquidas SF ≤ 2.8 y no peor que en la visita basal. • Alcanzar la respuesta endoscópica por el SES-CD en la semana 40 del periodo de mantenimiento. • Alcanzar la remisión clínica según el CDAI en la semana 40 del periodo de mantenimiento. • Alcanzar la remisión clínica por la frecuencia de heces y dolor abdominal en la semana 40 en el periodo de mantenimiento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 12 and Week 40 |
Semana 12 y semana 40 |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Also assess Immunogenicity of ABBV-154 |
Evaluar también la inmunogenicidad de ABBV-154 |
|
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 | 5 |
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 | 51 |
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 |
Canada |
Israel |
Japan |
Korea, Republic of |
New Zealand |
Russian Federation |
South Africa |
Taiwan |
United States |
Austria |
Belgium |
Bulgaria |
France |
Germany |
Italy |
Netherlands |
Poland |
Slovakia |
Spain |
United Kingdom |
Czechia |
Greece |
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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
|
The end-of-study is defined as 70 days after the last study drug administration. |
El final del estudio está definido como 70 días después de la última dosis de fármaco de estudio. |
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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 | |
E.8.9.1 | In the Member State concerned months | 41 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 41 |