E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque psoriasis |
Psoriasis en placas moderada o grave |
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E.1.1.1 | Medical condition in easily understood language |
Psoriasis is a systemic inflammatory disorder that causes red, raised scaly patches on the skin. |
La psoriasis es un trastorno inflamatorio generalizado que provoca enrojecimiento, protuberancias y descamación cutáneas. |
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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 | 10071117 |
E.1.2 | Term | Plaque psoriasis |
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 |
• Efficacy of mirikizumab induction dosing compared to secukinumab and placebo in subjects based on sPGA (0,1) and PASI 90 at Week 16 |
Eficacia del tratamiento de inducción con mirikizumab respecto a la de secukinumab y el placebo, de acuerdo con el porcentaje de pacientes que alcancen un índice sPGA (0, 1) y una respuesta PASI 90 en la semana 16. |
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E.2.2 | Secondary objectives of the trial |
• Efficacy of mirikizumab induction dosing compared to placebo based on PASI 75 at Week 4; PASI 75, PASI 100, BSA ≤1% , PSS symptoms score of 0 in those with a PSS symptoms score ≥1 at baseline and and DLQI (0,1) with DLQI baseline score >1 at Week 16
• Efficacy of mirikizumab maintenance dosing compared to secukinumab based on PASI 90 at Week 24; sPGA(0,1), PASI 90, PASI 100 at week 52 |
Eficacia del tratamiento de inducción con mirikizumab respecto a la del placebo, de acuerdo con el porcentaje de pacientes que alcancen una respuesta PASI 75 en la semana 4; el porcentaje de pacientes que en la semana 16 alcancen una respuesta PASI 75, una respuesta PASI 100, tengan ≤ 1 % de la superficie corporal afectada, presenten una puntuación de 0 en la escala de los síntomas de la psoriasis (PSS) y cuya puntuación basal en esta escala fuera ≥ 1 y alcancen un índice DLQI (0,1) y cuya puntuación basal en este índice fuera > 1. Eficacia del tratamiento de mantenimiento con mirikizumab respecto a la de secukinumab, de acuerdo con el porcentaje de pacientes que alcancen una respuesta PASI 90 en la semana 24; y un índice sPGA (0, 1), una respuesta PASI 90 y PASI 100 en la semana 52. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Present with chronic plaque psoriasis based on an investigator-confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline, and meet the following criteria:: a) involving ≥10% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening (Visit 1) and baseline (Visit 2), and b) sPGA score of ≥3 at screening (Visit 1) and baseline (Visit 2). - Candidate for systemic therapy and/or phototherapy - Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception for the duration of the trial - Are ≥18 years of age |
- Presencia de psoriasis en placas crónica de acuerdo con el diagnóstico confirmado por el investigador de psoriasis vulgar crónica al menos desde 6 meses antes del período basal y que el paciente cumpla los criterios siguientes: a) afectación ≥ 10 % de la superficie corporal (SC) y puntuación total en el índice PASI ≥ 12 en la piel afectada en la selección (visita 1) y en el período basal (visita 2), y b) puntuación ≥ 3 en la evaluación sPGA en la selección (visita 1) y en el período basal (visita 2).
- Tributario de tratamiento sistémico o fototerapia. - Las mujeres deben presentar un resultado negativo en una prueba de embarazo antes del inicio del tratamiento y estar de acuerdo en utilizar métodos anticonceptivos durante el estudio. - Tener ≥ 18 años. |
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E.4 | Principal exclusion criteria |
- Have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect patient safety within the study or of interfering with the interpretation of data. - Are women who are breastfeeding or plan to breastfeed during study - Have had serious, opportunistic or chronic/recurring infection within 3 months prior to screening - Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study. - Have any other skin conditions (excluding plaque psoriasis) that would affect interpretation of the results - Have received systemic nonbiologic therapy within 28 days prior to baseline - Have received topical treatment within 14 days prior to baseline - Have prior use of secukinumab - Have received anti-tumor necrosis factor (TNF) targeting biologics within 8 weeks prior to baseline - Have previous exposure to any biologic therapy targeting IL-12/23 (p40 subunit) or IL-23 (p19 subunit) or IL-17, either marketed or investigational. |
- Presentar en la selección una enfermedad inestable o sin controlar, entre otras, cerebro-cardiovasculares, respiratorias, hepáticas, renales, gastrointestinales, endocrinas, hematológicas o neurológicas o valores analíticos anormales que, según el criterio del investigador, supongan un riesgo para la seguridad del paciente durante el estudio o interfieran en la interpretación de los datos. - Mujeres que den el pecho o tengan previsto hacerlo durante el estudio. - Infección oportunista o crónica/recurrente y grave en el transcurso de los 3 meses anteriores a la selección. - Haber recibido una vacuna con el bacilo de Calmette-Guérin (BCG) en los 12 últimos meses o una vacuna elaborada con microbios vivos (incluidas las atenuadas) en el transcurso de las 12 semanas anteriores al período basal o tener previsto recibir una vacuna de este tipo durante el estudio. - Presentar cualquier otra enfermedad cutánea (salvo la psoriasis en placas) que afecte la interpretación de los resultados. - Haber recibido tratamiento sistémico con productos no biológicos en el transcurso de los 28 días anteriores al período basal.
- Haber recibido tratamiento tópico en el transcurso de los 14 días anteriores al período basal. - Haber recibido secukinumab anteriormente. - Haber recibido productos biológicos dirigidos al factor de necrosis tumoral (TNF) en el transcurso de las 8 semanas anteriores al período basal. - Haber recibido anteriormente cualquier tratamiento biológico dirigido a la IL-12/23 (subunidad p40), la IL-23 (subunidad p19) o la IL-17, tanto comercializados como en investigación. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Static Physician's Global Assessment (sPGA)(0,1) and Psoriasis Area and Severity Index 90 (PASI 90) |
Evaluación estática global por parte del médico (sPGA)(0, 1) e índice de gravedad y área de la psoriasis 90 (PASI 90) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoints to assess whether mirikizumab induction dosing is superior to placebo: Week 16- sPGA (0,1) PASI 90
Timepoints to assess whether mirikizumab induction dosing is noninferior to secukinumab: Week 16- sPGA (0,1) PASI 90 |
Momentos en los que se evaluará si el tratamiento de inducción con mirikizumab es superior al placebo:
Semana 16: sPGA (0,1), PASI 90 Momentos en los que se evaluará si el tratamiento de inducción con mirikizumab no es inferior a secukinumab:
Semana 16: sPGA (0, 1), PASI 90. |
|
E.5.2 | Secondary end point(s) |
PASI 75, PASI 100, BSA ≤1% with psoriasis involvement, PSS, DLQI, PASI 90, sPGA (0,1) |
PASI 75, PASI 100, ≤ SC afectada con psoriasis, PSS, DLQI, PASI 90, sPGA (0, 1) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints to assess whether mirikizumab induction dosing is superior to placebo: Week 4- PASI 75 Week 16- PASI 75, PASI 100, BSA ≤1% with psoriasis involvement, PSS symptoms, DLQI
Timepoints to assess whether mirikizumab induction dosing is noninferior to secukinumab: Week 24- PASI 90 Week 52- sPGA (0,1), PASI 90, PASI 100
Timepoint to assess whether mirikizumab maintenance Q8W dosing is superior to secukinumab Week 52- sPGA (0,1) PASI 90 |
Momentos en los que se evaluará si el tratamiento de inducción con mirikizumab es superior al placebo:
Semana 4: PASI 75
Semana 16: PASI 75, PASI 100, ≤ 1 % de la SC afectada con psoriasis, síntomas (PSS), DLQI
Momentos en los que se evaluará si el tratamiento de inducción con mirikizumab no es inferior a secukinumab:
Semana 24: PASI 90
Semana 52: sPGA (0, 1), PASI 90, PASI 100
Momento en el que se evaluará si el tratamiento de mantenimiento con mirikizumab es superior a secukinumab: Semana 52: sPGA (0, 1), PASI 90 |
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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 | No |
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 | 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 | No |
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 |
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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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 71 |
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 |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Israel |
Italy |
Japan |
Korea, Republic of |
Poland |
Spain |
United Kingdom |
United States |
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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
|
LVLS |
Última visita del último paciente |
|
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 | 5 |
E.8.9.1 | In the Member State concerned days | |
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 | 5 |