E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hidradenitis suppurativa |
hidradenitis supurativa |
|
E.1.1.1 | Medical condition in easily understood language |
a long term skin disease characterized by the occurrence of inflamed and swollen lumps |
Una enfermedad de la piel a largo plazo caracterizada por la aparición de bultos inflamados e hinchados |
|
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 | 10020041 |
E.1.2 | Term | Hidradenitis suppurativa |
E.1.2 | System Organ Class | 100000004858 |
|
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 compared to placebo with respect to HiSCR after 16 weeks of treatment. |
Demostrar la eficacia de secukinumab comparado con placebo con respecto a la HiSCR después de 16 semanas de tratamiento. |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate the efficacy of secukinumab compared to placebo after 16 weeks of treatment with respect to: ● proportion of patients with HS flares ● proportion of patients with clinical response in HS related skin pain. |
Demostrar la eficacia de secukinumab comparado con placebo después de 16 semanas con respecto a: • Porcentaje de pacientes con brotes de HS • Porcentaje de pacientes con respuesta clínica en el dolor cutáneo relacionado con la HS |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
a. Optional skin biopsy sampling sub-study: Objectives: The substudy may include, but is not limited to analyses to gain a better understanding of the mechanistic aspects of HS. These data may also support the identification of pathways/markers that characterize the disease or response to treatment with secukinumab. Exploratory biopsy research will entail histology and transcriptomics. b. Optional DNA sampling: this is standard and used in most studies. Objectives: Exploratory DNA research studies are planned as a part of this study with the objectives of identifying genetic factors which may (1) predict response to treatment with secukinumab; (2) predict relative susceptibility to drug-drug interactions; (3) predict genetic predisposition to side effects; or (4) be related to HS or autoimmune diseases. |
a. Subestudio opcional de muestras de biopsia de piel: Objetivo: este subestudio puede incluir, pero no está limitado a, análisis para alcanzar un mejor conocimiento de los aspectos mecanísticos de la HS. Estos datos también pueden apoyar la identificación de vías/marcadores que caractericen la enfermedad o la respuesta al tratamiento con secukinumab. La investigación exploratoria de biopsia incluirá histología y transcriptómica b. Muestreo opcional de ADN: es estándar y se utiliza en la mayoría de los estudios. Objetivos: se han planificado estudios exploratorios de investigación de ADN como parte de este estudio con los objetivos de identificar factores genéticos que puedan (1) predecir la respuesta al tratamiento con secukinumab; (2) predecir susceptibilidad relativa a las interacciones fármaco-fármaco; (3) predecir la predisposición genética a los efectos secundarios, o (4) estar relacionados con la HS o con enfermedades autoinmunes. |
|
E.3 | Principal inclusion criteria |
Patients eligible for inclusion in this study must meet all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male and female patients ≥ 18 years of age. 3. Diagnosis of HS ≥ 1 year prior to baseline. 4. Patients with moderate to severe HS defined as: - A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND - Inflammatory lesions should affect at least 2 distinct anatomic areas 5. Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment |
Los pacientes elegibles deberán de cumplir todos los siguientes criterios para su inclusión: 1. El consentimiento informado por escrito deberá obtenerse antes de que se realice cualquier evaluación. 2. Pacientes hombres y mujeres >/= 18 años. 3. Diagnóstico de HS >/= 1 año antes de la visita basal. 4. Pacientes con HS de moderada a severa, definida como: • Un total de por lo menos 5 lesiones inflamatorias, es decir, abscesos y/o nódulos inflamatorios Y • Las lesiones inflamatorias deben afectar al menos a 2 áreas anatómicas distintas 5. Los pacientes deberán aceptar el uso diario de antisépticos tópicos de venta libre en las áreas afectadas por lesiones de HS, mientras participen en el estudio. |
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E.4 | Principal exclusion criteria |
Patients meeting any of the following criteria are not eligible for inclusion in this study. 1. Total fistulae count ≥ 20 at baseline. 2. Any other active skin disease or condition that may interfere with assessment of HS. 3. Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications. 4. 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 patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy. 5. Current severe progressive or uncontrolled diseases which renders the patient unsuitable for the trial or puts the patient 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. 6. Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to. 7. For patients enrolling in the non-antibiotic strata: use of systemic antibiotics for the treatment of HS within 28 days before baseline. For patients enrolling in the antibiotic strata: patients enter the study under concomitant treatment with systemic antibiotics (as per protocol) on a stable dose (defined as a dose or dose regimen that has not changed in the previous 28 days before baseline and is considered unlikely to change at least for the first 16 weeks during the study). 8. History of hypersensitivity to any of the study drug constituents. 9. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 A/F or the IL-17 receptor. 10. History of chronic or recurrent systemic infections or active systemic infections during the last two weeks (exception: common cold) prior to randomization. 11. Evidence of tuberculosis infection as defined by a positive QuantiFERON® TB-Gold test (QFT) at screening. Patients with a positive or indeterminate QFT test may participate in the study if a full tuberculosis work-up (according to local practice/guidelines) completed within 12 weeks prior to randomization, establishes conclusively that the patient has no evidence of active or latent tuberculosis. 12. Medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or C prior to randomization, except for hepatitis C successfully treated and cured. 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 skin 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. History or evidence of ongoing alcohol or drug abuse, which in the opinion of the investigator will prevent the patient from adhering to the protocol and completing the study. 15. Pregnant or lactating women. 16. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. in European Union (EU) 20 weeks). |
Los pacientes que cumplan alguno de los siguientes criterios no serán elegibles para la inclusión en este estudio: 1. Recuento total de fistulas >/= 20 en la visita basal. 2. Cualquier otra enfermedad o afección cutánea activa que pueda interferir con la evaluación de la HS. 3. Enfermedades inflamatorias activas en curso, excepto HS, que precisen tratamiento con medicaciones prohibidas (véase Tabla 6-2). 4. Uso o uso previsto de tratamiento prohibido. Deben cumplirse los periodos de lavado detallados en el protocolo (véase Tabla 6-2). 5. Antecedentes de hipersensibilidad a cualquiera de los componentes de la medicación del estudio. 6. Antecedentes de enfermedad linfoproliferativa o de cualquier neoplasia conocida o antecedentes de malignidad de cualquier sistema orgánico tratada o no tratada dentro de los últimos 5 años, independientemente de si existe evidencia de recurrencia local o de metástasis (excepto en el caso de enfermedad de Bowen cutánea, carcinoma de células basales o queratosis actínica que haya sido tratada sin evidencia de recurrencia en las últimas 12 semanas; carcinoma en situ del cuello del útero o pólipos de colon malignos no invasivos que hayan sido extirpados). 7. Mujeres embarazadas o en periodo de lactancia. PAra el resto de criterios vease el protocolo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Achievement of HiSCR at Week 16. HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses or in the number of draining fistulae. |
HiSCR en la semana 16, definida como una disminución del recuento de abscesos y nódulos inflamatorios (NI) de al menos el 50%, sin incremento del número de abscesos ni de fístulas drenantes |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Flaring up to Week 16. Flare is defined as at least a 25% increase in AN counts with a minimum increase of 2 AN relative to baseline. ● Achievement of NRS30 at Week 16, among subjects with baseline NRS ≥ 3. NRS30 is defined as at least a 30% reduction from baseline in Patient's Global Assessment of Skin Pain - at worst |
Brotes durante 16 semanas: El brote se define como un aumento del recuento de NI de al menos el 25% con un incremento mínimo de 2 NI, respecto al recuento basal. Dolor/NRS30 en la semana 16: Pacientes que alcancen NSR30 en la semana 16, entre los pacientes con NRS ≥ 3 basal. La NSR30 se define como una reducción de por lo menos el 30% y una reducción de por lo menos 1 unidad, respecto a la puntuación basal, en la evaluación global del paciente del color cutáneo. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at/ up to Week 16 |
en/hasta la semana 16 |
|
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 | No |
E.6.11 | Pharmacogenomic | Yes |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 61 |
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 |
Argentina |
Australia |
Austria |
Belgium |
Brazil |
Bulgaria |
Canada |
Czech Republic |
France |
Germany |
Greece |
Hungary |
India |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Philippines |
Poland |
Portugal |
Russian Federation |
Slovakia |
Spain |
Sweden |
Switzerland |
Taiwan |
Turkey |
United Kingdom |
United States |
Jordan |
|
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
|
LVLS |
Último paciente última visita |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |