E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ankylosing Spondylitis |
Espondilitis anquilosante |
|
E.1.1.1 | Medical condition in easily understood language |
Ankylosing Spondylitis |
Espondilitis anquilosante |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002557 |
E.1.2 | Term | Ankylosing spondylitis and other inflammatory spondylopathies |
E.1.2 | System Organ Class | 100000004859 |
|
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 |
Primary objective is to compare efficacy of BI 655066 versus placebo at 12 weeks, based on ASAS 40 response criteria. |
El objetivo principal es comparar la eficacia de BI 655066 frente a placebo a las 12 semanas a partir de los criterios de respuesta ASAS 40. |
|
E.2.2 | Secondary objectives of the trial |
To compare efficacy of BI 655066 versus placebo at 24 weeks, based on change in ASDAS score (key secondary) To compare efficacy of BI 655066 versus placebo at 24 weeks, based on ASAS 40 response criteria To compare efficacy of BI 655066 versus placebo at 24 weeks based on ASAS 20, ASAS 5/6, ASAS remission criteria, change in BASDAI score |
? Comparar la eficacia de BI 655066 frente a placebo a las 24 semanas, a partir del cambio en la puntuación ASDAS (variable secundaria clave) ? Comparar la eficacia de BI 655066 frente a placebo a las 24 semanas a partir de los criterios de respuesta ASAS 40. ? Comparar la eficacia de BI 655066 frente a placebo a las 24 semanas a partir de los criterios ASAS 20, ASAS 5/6, criterios ASAS de remisión y el cambio en la puntuación BASDAI. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male and female patients - Age >= 18 years and =< 70 years. - Definite AS based on the modified New York criteria (1984) - Documented disease duration >= 3 months at screening - Active disease at screening, defined as: a. BASDAI score (0-10) >= 4, AND b. Spinal pain level assessed by the 2nd BASDAI question (0-10) >= 4 (2nd question from BASDAI will be used here) - Have either a documented inadequate response for axial symptoms to 30 days of optimal daily doses of at least two non-steroidal anti-inflammatory drugs (NSAIDs), or documented intolerance to NSAIDs |
- Pacientes varones y mujeres. - Edad >= 18 años y <= 70 años. - Espondilitis anquilosante, definida según los criterios modificados de Nueva York (1984) - Duración justificada de la enfermedad >= 3 meses, en la selección. - Enfermedad activa en el momento de la selección, definida como: a. Puntuación BASDAI (0-10) >= 4, Y b. Evaluación del nivel de dolor espinal mediante la 2ª pregunta de BASDAI (0-10) >= 4 - Presentar una respuesta insuficiente, confirmada de los síntomas axiales, a los 30 días de estar recibiendo dosis diarias óptimas de un mínimo de dos fármacos antiinflamatorios no esteroideos (NSAID) o tener una intolerancia confirmada a los NSAID. |
|
E.4 | Principal exclusion criteria |
- Radiographic evidence of total ankylosis of the spine at screening or before (spinal X-Ray examinations at screening visit/ during screening period are not mandatory - see footnote 12 from Flow-Chart 1). - Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental - Previous or current participation in a clinical trial testing an investigational drug for AS - Usage of any investigational drug within 30 days prior to randomization or the planned use of an investigational drug during the course of the actual study - Active uveitis or inflammatory bowel disease at screening - Diagnosed psoriatic arthritis at screening, satisfying the modified New York criteria - Patients who had received intraarticular injection(s) with corticosteroids within 4 weeks prior to screening visit |
- Prueba radiológica de anquilosis total de la columna, anterior a la selección o en ésta (no es obligatorio disponer de una radiografía de columna en la visita de selección ni durante el periodo de selección - véase la nota al pie, n.º 12 en el Diagrama de flujo 1). -. Paciente tratado previamente con algún inmunomodulador para la AS ya sea registrado o en fase de experimentación. - Participación anterior o en el presente en un ensayo clínico que pruebe un fármaco experimental para la AS. Uso de un fármaco en fase de investigación en los 30 días antes de la aleatorización o que esté previsto su uso durante el curso del presente ensayo. - Uveítis activa o enfermedad intestinal inflamatoria en el momento de la selección. - Artritis psoriásica en la selección diagnosticada , que cumpla los criterios modificados de Nueva York. - Pacientes que hayan recibido una o más inyecciones intraarticulares con corticoesteroides en las 4 semanas anteriores a la visita de selección. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1: ASAS 40 response |
1: respuesta ASAS 40 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1: Change in ASDAS score at Week 12 as compared to baseline (key secondary) 2: ASAS 5/6 response 3: ASAS remission criteria 4: ASAS 20 response 5: ASAS 40 response 6: Change in BASDAI score as compared to baseline |
1: Cambio en la puntuación ASDAS en la semana 12 en comparación con el valor basal (variabla secundaria clave) 2: Respuesta ASAS 5/6 3: Criterios de remisión ASAS 4: Respuesta ASAS 20 5: Respuesta ASAS 40 6: Cambio en la puntuación BASDAI en comparación con el valor basal |
|
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 24
6: week 12 |
1: semana 12
2: semana 12
3: semana 12
4: semana 12
5: semana 24
6: semana 12 |
|
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 | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Comparación de dosis |
Dose comparison |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 28 |
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 |
Finland |
France |
Germany |
Hong Kong |
Italy |
Korea, Republic of |
Netherlands |
Spain |
Taiwan |
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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 29 |