E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque psoriasis |
Psoriasis en placas de moderada a 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 that often itch or bleed and are painful. |
La psoriasis es un trastorno inflamatorio generalizado que provoca protuberancias cutáneas con enrojecimiento y descamación, que, con frecuencia, pican o sangran y son dolorosas |
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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 |
To access long-term maintenance of efficacy of mirikizumab in subjects based upon sPGA (0, 1) and ≥90% improvement in PASI 90 among those who entered Study AMAH with sPGA (0,1) and PASI 90 response. |
Determinar el mantenimiento a largo plazo de la eficacia de mirikizumab en función de la sPGA (0, 1) y la mejoría ≥90 % en el índice PASI 90 en los pacientes que en el momento de inclusión en el estudio AMAH presentaran sPGA (0,1) y respuesta PASI 90 |
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E.2.2 | Secondary objectives of the trial |
To access long term efficacy and patient reported outcomes with mirikizumab treatment in subjects based upon sPGA (0,1), PASI 90, PASI 100, PSS symptoms score of 0 in those with a PSS symptoms score ≥1 at baseline, (DLQI) score of 0,1 with baseline score >1 and % change in (PPASI), (PSSI) and (NAPSI). |
Determinar la eficacia y los resultados notificados por los pacientes a largo plazo con el tratamiento con mirikizumab en función de los pacientes que presenten sPGA (0,1), índices PASI 90 y PASI 100, puntuación de 0 en la escala de gravedad de los síntomas de la psoriasis (PSS) (de entre los que presentaran una puntuación ≥1 en la escala PSS en el momento inicial), puntuación de 0, 1 en el índice DLQI (de entre los que presentaran una puntuación inicial >1) y pacientes que presenten variación porcentual en los índices PPASI, PSSI y NAPSI |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Have completed the last visit of an eligible study period of 1 of the originator studies (Study AMAF, AMAJ, AMAK, or AMBK). - Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception for the duration of the trial -Have given written informed consent as a legal adult according to local regulations |
- Haber completado la última visita del período de selección de uno de los estudios previos (estudios AMAF, AMAJ, AMAK o AMBK). - Las pacientes deben presentar resultado negativo en una prueba de embarazo antes del inicio del tratamiento y estar de acuerdo en utilizar medidas anticonceptivas durante el estudio. - Haber proporcionado el consentimiento informado de conformidad con la normativa local |
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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. - Have a known hypersensitivity to mirikizumab or any component of this investigational product. - Have had investigational product permanently discontinued during a previous mirikizumab study. - Have had temporary investigational product interruption at any time during or at the final study visit of a previous mirikizumab study and, in the opinion of the investigator, restarting mirikizumab would pose an unacceptable risk for the patient’s participation in the study. - Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol |
- Presentar enfermedades inestables o sin controlar, entre otras, cerebro-cardiovasculares, respiratorias, hepáticas, renales, gastrointestinales, endocrinas, hematológicas, o enfermedades neurológicas o valores analíticos anómalos durante la selección que, en opinión del investigador, podrían afectar la seguridad de los pacientes del estudio o interferir en la interpretación de los datos. - Presentar hipersensibilidad conocida a mirikizumab o a cualquiera de los componentes de este producto en fase de investigación. - Haber dejado de recibir definitivamente el tratamiento con el producto en fase de investigación durante un estudio previo de mirikizumab. - Haber dejado de recibir temporalmente el tratamiento con el producto en fase de investigación durante un estudio previo de mirikizumab (incluida la visita final) y, en opinión del investigador, que reanudar la administración de mirikizumab constituya un riesgo inaceptable para el paciente en caso de que participe en el estudio. - Presentar cualquier otra enfermedad que, en opinión del investigador, impida al paciente entender la naturaleza, el alcance y las posibles consecuencias del estudio o le impida seguir y completar el protocolo |
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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) y puntuación de 90 en el índice de gravedad y área de la psoriasis (PASI 90) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Over the course of the study •Proportion of patients with an sPGA (0,1) and ≥90% improvement in PASI (PASI 90) among those who entered Study AMAH with sPGA (0,1) and PASI 90 response |
Durante el estudio: • Porcentaje de pacientes con una sPGA (0, 1) y una mejoría ≥90 % en el índice PASI (PASI 90) de entre los que presentaban sPGA (0, 1) y respuesta PASI 90 en el momento de inclusión en el estudio AMAH |
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E.5.2 | Secondary end point(s) |
sPGA (0,1), PASI 90, PASI 100, PSS symptoms score, DLQI, PPASI, PSSI and NAPSI |
sPGA (0, 1), PASI 90, PASI 100, puntuación en la escala de los síntomas de la psoriasis (PSS), DLQI, PPASI, PSSI y NAPSI |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Over the course of the study •Proportion of patients achieving sPGA (0,1), PASI 90, PASI 100 •Proportion of patients achieving PSS symptom score of 0 & in those with a PSS symptoms score ≥1 at baseline and (DLQI) score of 0,1 with baseline score >1 •Percent change in total score of PPASI, PSSI and NAPSI in those with palmoplantar involvement, scalp involvement and fingernail involvement at baseline |
Durante el estudio: • Porcentaje de pacientes que alcancen una sPGA (0, 1) e índices PASI 90 y PASI 100. • Porcentaje de pacientes que alcancen una puntuación de 0 en la escala PSS de entre los que presentaran una puntuación ≥1 en el momento inicial y una puntuación de 0,1 en el índice DLQI de entre los que presentaran una puntuación >1 en el momento inicial. • Variación porcentual en la puntuación total de los índices PPASI, PSSI y NAPSI en los pacientes que en el momento inicial presentaran afectación palmoplantar, en el cuero cabelludo o en las uñas de los dedos de las manos. |
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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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | 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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 94 |
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 |
Mexico |
Poland |
Russian Federation |
Spain |
Taiwan |
United Kingdom |
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
|
LVLS |
Última visita del último paciente (UVUP) |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |