E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque-type psoriasis |
Psoriasis en placas de moderada a grave |
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E.1.1.1 | Medical condition in easily understood language |
Psoriasis looks like red, raised scaly areas of the skin |
La psoriasis se ve como áreas escamosas y enrojecidas de la piel. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
E.1.2 | System Organ Class | 100000004858 |
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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 |
To demonstrate the efficacy of secukinumab 300 mg when administered in 2 mL auto-injector in subjects with plaque-type psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoint) at Week 12, compared to placebo. |
Demostrar la eficacia de secukinumab 300 mg cuando se administra en autoinyector de 2 ml comparado con placebo en pacientes con psoriasis en placas con respecto a las respuestas del Índice de severidad y área de la psoriasis (PASI) 75 y respuesta 0 o 1 según la evaluación global del investigador modificada 2011 (IGA mod. 2011) (variables co-principales) en la semana 12. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate efficacy of secukinumab 300 mg 2 mL AI in subjects with plaque-type psoriasis w.r.t. PASI 90 at Week 12, compared to placebo. To assess efficacy of secukinumab 300 mg 2 mL AI in subjects with plaque-type psoriasis w.r.t. PASI score, IGA mod 2011 score, PASI 50/75/90/100 and IGA mod 2011 0 or 1 response up to Week 12 compared to placebo, and over time up to Week 52. To investigate clinical safety and tolerability of secukinumab 300 mg 2 mL AI as assessed by vital signs, clinical laboratory variables, and AE monitoring, compared to placebo. To assess subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the new secukinumab 2 mL AI utilizing a self-administered SIAQ and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration. To investigate effects of secukinumab 300 mg 2 mL AI w.r.t. DLQI 0 or 1 achievement and DLQI changes at Week 12 compared to placebo, and over time up to Week 52. |
Demostrar la eficacia de secukinumab 300 mg cuando se administra en autoinyector de 2 ml comparado con placebo en pacientes con psoriasis en placas con respecto a la respuesta PASI 90 en la semana 12. Evaluar la eficacia de secukinumab 300 mg cuando se administra en autoinyectores de 2 ml comparado con placebo en pacientes con psoriasis en placas con respecto a la puntuación PASI, la puntuación IGA mod. 2011, las respuestas PASI 50/75/90/100 y la respuesta IGA mod. 2011 0 o 1 hasta la semana 12 y a lo largo del tiempo hasta la semana 52. Investigar la seguridad y tolerabilidad clínicas de secukinumab 300 mg en autoinyectores de 2 ml comparado con placebo evaluadas según las constantes vitales, variables clínicas de laboratorio y monitorización de acontecimientos adversos (AA). Para otros objetivos ver protocolo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations. 2. Men or women of at least 18 years of age at the time of Screening. 3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization. 4. Moderate to severe psoriasis as defined at Randomization by: • PASI score of 12 or greater, and • IGA mod 2011 score of 3 or greater (based on a scale of 0 – 4), and • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater. 5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by • Topical treatment and/or • Phototherapy and/or • Previous systemic therapy |
1. Los pacientes deben ser capaces de comprender y comunicarse con el investigador y cumplir los requisitos del estudio y deben presentar un consentimiento informado escrito, fechado y firmado antes de que se realice cualquier actividad relacionada con el estudio. Cuando proceda, un representante legal firmará también el consentimiento informado del estudio de acuerdo con la normativa y legislación locales. 2. Hombres o mujeres de al menos 18 años de edad en el momento de la selección. 3. Psoriasis crónica en placas existente durante al menos 6 meses y diagnosticada antes de la aleatorización. 4. Psoriasis de moderada a grave definida en la aleatorización basándose en: • Puntuación PASI de 12 o superior y • Puntuación IGA mod. 2011 de 3 o superior (basada en una escala de 0 – 4) y • Área de superficie corporal (BSA) afectada por psoriasis en placas del 10 % o superior. 5. Candidato a tratamiento sistémico. El candidato a tratamiento sistémico se define como un paciente que tiene psoriasis crónica en placas de moderada a grave que se considera inadecuadamente controlada mediante • Tratamiento tópico o • Fototerapia o • Tratamiento sistémico previo |
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E.4 | Principal exclusion criteria |
1. Forms of psoriasis other than chronic plaque-type at Screening or Randomization. 2. Drug-induced psoriasis at Randomization. 3. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit Ultraviolet (UV) light exposure during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited. 4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 5. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations. 6. Pregnant or lactating women. 7. Women of child-bearing potential. 8. Active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis (PsA) that might confound the evaluation of the benefit of secukinumab therapy. Also, underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy. In addition, current severe progressive or uncontrolled diseases which renders the subject unsuitable for the trial or puts the subject at increased risk, including any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol. 9. Presence of : • Significant medical problems, including but not limited to the following: uncontrolled hypertension (repeated values of systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 95 mmHg), congestive heart failure (New York Heart Association status of class III or IV). • Serum creatinine level exceeding 2.0 mg/dL (176.8 µmol/L). • Total white blood cell (WBC) count < 2,500/µL, or platelets < 100,000/µL or neutrophils < 1,500/µL or hemoglobin < 8.5 g/dL at Screening. 10. Active systemic infections during the last two weeks (exception: common cold) prior to randomization or any infection that reoccurs on a regular basis. 11. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (TB) infection as defined by a positive central laboratory test result at screening. Subjects with a positive test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines prior to randomization. 12. Past medical history record or current infection with Human Immunodeficiency Virus, hepatitis B or hepatitis C prior to Randomization. 13. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for Bowen’s disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). 14. Inability or unwillingness to undergo repeated venipuncture (eg, because of poor tolerability or lack of access to veins) or to self-administer sub-cutaneous injections. 15. History or evidence of ongoing alcohol or drug abuse, within the last six months before Randomization. 16. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes. |
1. Formas de psoriasis salvo psoriasis crónica en placas (p. ej., psoriasis pustulosa, eritrodérmica y gutata) en la selección o aleatorización. 2. Psoriasis provocada por fármacos (es decir nueva aparición o exacerbación actual por betabloqueantes, inhibidores de los canales de calcio o litio) en la aleatorización. 3. Uso actual de tratamientos prohibidos. Se deben cumplir los periodos de lavado descritos en el protocolo. Los pacientes que no deseen limitar la exposición a la luz ultravioleta (UV) (p. ej., tomar el sol o utilizar dispositivos de bronceado) durante el estudio no se considerarán elegibles para este estudio, ya que está prohibida la exposición a la luz UV. Nota: también está prohibida la administración de vacunas vivas 6 semanas antes de la aleatorización o durante el estudio. 4. Exposición previa a secukinumab (AIN457) o a cualquier otro fármaco biológico directamente dirigido contra la interleuquina (IL)-17 o el receptor de IL-17. 5. Uso de otros fármacos en investigación en el momento de la inclusión o en un periodo de 5 semividas o de 30 días, aquel periodo que sea más largo, previos al inicio del tratamiento en investigación hasta que el efecto farmacodinámico previsto vuelva a los valores basales, o durante más tiempo si así lo exige la normativa local. 6. Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta que finalice la gestación, confirmado por un resultado positivo en la analítica de gonadotropina coriónica humana (hCG). 7. Antecedentes de enfermedad linfoproliferativa, cualquier tumor maligno o antecedentes de tumor maligno de cualquier sistema orgánico tratado o no tratado durante los 5 años anteriores a la selección, independientemente de que exista evidencia de recurrencia local o metástasis (excepto enfermedad de Bowen, carcinoma de células basales o queratosis actínicas que hayan sido tratadas y sin signos de reaparición durante las últimas 12 semanas; carcinoma de cérvix in situ o pólipos de colon malignos no invasivos que hayan sido extirpados). 8. Antecedentes de hipersensibilidad a cualquier componente del fármaco del estudio.
Para el reto de criterios consultar protocolo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
PASI 75 response and IGA mod 2011 0 or 1 response |
Respuesta PASI 75 y respuesta IGA mod 2011 0 o 1 |
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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) |
1) PASI 90 2) PASI 50/75/90/100 and IGA mod 2011 0 or 1 3) Vital signs, lab variables, AE 4) SIAQ questionnaire and administration observation 5) DLQI 0 or 1 |
1) PASI 90 2) PASI 50/75/90/100 e IGA mod 2011 0 o 1 3) Signos vitales, variables de laboratorio, AE 4) Cuestionario SIAQ y observación de la administración 5) DLQI 0 o 1 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- At Week 12: 1); 2); 5) - Over time up to Week 52: 2); 3); 4); 5) |
-En la semana 12: 1); 2); 5) -Con el tiempo hasta la semana 52: 2); 3); 4); 5) |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 |
Canada |
Germany |
Iceland |
Poland |
Spain |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
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
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LVLS |
Último paciente, última visita |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 4 |
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 | 7 |