E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Psoriasis is an inflammatory disease where the immune system attacks healthy skin, causing red scaly patches on the skin. |
La psoriasis es una enfermedad inflamatoria donde el Sistema inmune ataca a la piel sana, causando parches escamosos rojos en 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 | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
The primary objective of Study M15-997 is to investigate long-term safety and tolerability of risankizumab in subjects with psoriasis who have completed one of the preceding Phase 2/3 studies. |
El objetivo principal del estudio M15-997 investigar la seguridad y tolerabilidad a largo plazo de risankizumab en sujetos con psoriasis que hayan completado uno de los estudios anteriores de fase 2/3. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of Study M15-997 is to investigate the long-term efficacy of risankizumab in the treatment of psoriasis. |
El objetivo secundario del estudio M15-997 es investigar la eficacia a largo plazo de risankizumab en el tratamiento de la psoriasis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects with moderate to severe chronic plaque psoriasis who have completed one of the preceding studies 1311.3, 1311.4, 1311.28, 1311.30 and 1311.38. 2. Subjects must be candidates for prolonged open label risankizumab treatment according to investigator judgment |
1. Sujetos adultos con psoriasis en placas crónica de moderada a grave que hayan completado uno de los estudios anteriores 1311.3, 1311.4, 1311.28, 1311.30 y 1311.38. 2. Los sujetos deben ser candidatos para el tratamiento abierto prolongado con risankizumab según el juicio del investigador. |
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E.4 | Principal exclusion criteria |
1. Premature discontinuation for any reason in the preceding study. |
1. Discontinuación prematura por cualquier razón en el estudio anterior. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Achievement of PASI 90 |
Conseguir el PASI 90 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 132, Week 144, Week 156, End of Observation visit |
Semana 0, Semana 12, Semana 24, Semana 36, Semana 48, Semana 60, Semana 72, Semana 84, Semana 96, Semana 108, Semana 120, Semana 132, Semana 144, Semana 156, Visita final de observación. |
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E.5.2 | Secondary end point(s) |
Achievement of PASI 75 or 100 and achievement of sPGA score of clear or almost clear |
Conseguir un PASI 75 o 100 y una puntuación sPGA de resuelta o casi resuelta. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 132, Week 144, Week 156, End of Observation visit |
Semana 0, Semana 12, Semana 24, Semana 36, Semana 48, Semana 60, Semana 72, Semana 84, Semana 96, Semana 108, Semana 120, Semana 132, Semana 144, Semana 156, Visita final de observación. |
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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 | 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 | No |
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 | 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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 72 |
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 |
Canada |
European Union |
Japan |
Korea, Republic of |
Mexico |
Taiwan |
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
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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 | 9 |
E.8.9.1 | In the Member State concerned days | 3 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 3 |