E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Chronic Plaque Psoriasis |
Psoriasis en placas crónica de grado moderado o severo |
|
E.1.1.1 | Medical condition in easily understood language |
Moderate to Severe Chronic Plaque Psoriasis is a chronic inflammatory disease characterized by changes in the skin. |
La psoriasis en placas crónica de grado moderado o severo es una enfermedad inflamatoria crónica caracterizada por cambios en la piel |
|
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 | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
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 |
Compare the efficacy of bimekizumab versus secukinumab at achieving complete clearance (PASI100) in subjects with moderate to severe chronic plaque psoriasis (PSO). |
Comparar la eficacia de bimekizumab frente a secukinumab en la consecución de la resolución completa de las lesiones (PASI100) en sujetos con psoriasis crónica en placas de grado moderado o severo |
|
E.2.2 | Secondary objectives of the trial |
- Evaluate the efficacy of bimekizumab compared to secukinumab at pre-defined time-points - Assess Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs leading to withdrawal adjusted by duration of subject exposure to Investigational Medicinal Product (IMP) |
- Evaluar la eficacia de bimekizumab comparada con secukinumab en los puntos temporales predefinidas. - Evaluar los acontecimientos adversos surgidos durante el tratamiento (TEAEs), acontecimientos adversos serios (SAEs), y acontecimientos adversos surgidos durante el tratamiento que lleven a la retirada ajustada por la duración de la exposición del sujeto al medicamento en investigación. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female at least 18 years of age - Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit - Subject must have Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator’s Global Assessment (IGA) score >=3 on a 5 point scale - Subject must be a candidate for systemic PSO therapy and/or phototherapy - Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label - Female subject of child bearing potential must be willing to use highly effective method of contraception |
- Hombre o una mujer de al menos 18 años de edad - El sujeto debe haber presentado PSO en placas crónica durante al menos 6 meses antes de la visita de selección. - El sujeto debe tener una puntuación PASI ≥ 12 y la SC afectada por la PSO debe ser ≥ 10 %, además de tener una puntuación de la valoración global por parte del investigador (VGA) ≥ 3 en una escala de 5 puntos. - El sujeto debe ser candidato para el tratamiento sistémico contra la PSO o la fototerapia. - El investigador debe considerar que el sujeto es un candidato adecuado para el tratamiento con secukinumab según la ficha técnica regional y que no presenta contraindicaciones para recibir secukinumab de conformidad con la ficha técnica local. - Los sujetos de sexo femenino en edad fértil deben estar dispuestas a utilizar un método anticonceptivo muy eficaz |
|
E.4 | Principal exclusion criteria |
- Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection - Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study - Presence of active suicidal ideation or severe depression - Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer |
- El sujeto presenta una infección activa o antecedentes de infección (excepto un resfriado común), una infección grave, o una infección oportunista, recurrente o crónica - El sujeto presenta una infección vírica concurrente aguda o crónica por hepatitis B o C, o por el virus de la inmunodeficiencia humana (VIH) - El sujeto presenta una infección conocida por tuberculosis (TB), presenta un riesgo elevado de contraer infección por TB o bien presenta actualmente o tiene antecedentes de infección por micobacterias no tuberculosas (nontuberculous mycobacterium, MBNT). - El sujeto presenta alguna otra afección, incluidas las afecciones médicas o psiquiátricas que, a juicio del investigador, impedirían la aptitud del sujeto para su inclusión en el estudio. - Se da presencia activa de ideas suicidas o un resultado positivo en conducta suicida - El sujeto presenta alguna neoplasia maligna activa o antecedentes de neoplasia maligna dentro de los 5 años anteriores a la visita de selección, EXCEPTO el carcinoma cutáneo basocelular o epidermoide que se haya tratado y que se considere curado, o el cáncer cervicouterino in situ. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Psoriasis Area and Severity Index 100 (PASI100) response at Week 16 |
Respuesta 100 Indice de area y severidad de la psoriasis (PASI100) a la Semana 16 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. PASI75 response at Week 4 2. PASI90 response at Week 16 3. PASI100 response at Week 48 4. Investigator´s Global Assessment (IGA) response (0/1) at Week 16 5. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP) 6. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP 7. Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP |
1. respuesta PASI75 a la semana 14 2. respuesta PASI90 a la semana 16 3. respuesta PASI00 a la semana 48 4. Evaluación global del investigador (IGA) respuesta (0/1) a la semana 16 5. Número de acontecimientos adversos surgidos durante el tratamiento (TEAEs) ajustados por la duración del sujeto a la exposición al medicamento en investigación. 6. Número de acontecimientos adversos serios (SAEs) ajustados por la duración del sujero a la exposición al medicamento en investigación. 7. Número de TEAEs que conducen a la retirada ajustada por la duración de la exposición del sujeto al medicamento en investigación. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: Week 4 2,4: Week 16 3: Week 48 5, 6, 7: From Baseline to Safety Follow Up (up to Week 64) |
1: Semana 4 2,4: Semana 16 3: Semana 48 5, 6, 7: Desde el inico hasta el seguimiento de la seguridad (hasta la semana 64) |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenicity, Tolerability |
Inmunogenicidad, tolerabilidad |
|
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
France |
Germany |
Netherlands |
Poland |
Spain |
Turkey |
United Kingdom |
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
|
Last Subject Last Visit (LSLV) |
Ultimo sujeto última visita (LSLV) |
|
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 | 1 |
E.8.9.1 | In the Member State concerned days | 26 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 26 |