E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Palmoplantar Pustulosis |
Pustulosis Palmoplantar |
|
E.1.1.1 | Medical condition in easily understood language |
long term (chronic) condition which affects the skin of the palms and soles |
Condición a largo plazo (crónica) que afecta a la piel de las palmas de las manos y de los pies |
|
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 | LLT |
E.1.2 | Classification code | 10050185 |
E.1.2 | Term | Palmoplantar pustulosis |
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 |
The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo. |
El objetivo principal del ensayo es investigar la seguridad y eficacia de BI 655130 en pacientes con PPP mediante múltiples administraciones intravenosas en comparacion con placebo. |
|
E.2.2 | Secondary objectives of the trial |
Further objectives are the assessment of the pharmacokinetics of BI 655130 after multiple dosing in patients with PPP as well as the exploration of pharmacogenomics and the evaluation of surrogate markers. |
Otros objetivos son el cálculo de la farmacocinética de BI 655130 tras múltiples dosis en pacientes con PPP así como la investigación de su farmacogenómica y la evaluación de marcadores sustitutivos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female patients, 18 to 65 years of age at screening. - Palmoplantar Pustulosis - Further criteria apply |
- Pacientes varones o mujeres de entre 18 y 65 años en el momento de la selección - Pustulosis Palmoplantar - Otros criterios son aplicables |
|
E.4 | Principal exclusion criteria |
- Patients with associated plaque psoriasis ≥ 10% of the body surface area. - Presence or known history of anti-TNF-induced PPP-like disease. - Active or latent tuberculosis - Further criteria apply |
- Pacientes con psoriasis en placa asociada en ≥ 10% de la superficie corporal - Presencia o antecedentes de enfermedad similar a la pustulosis palmoplantar inducida por anti-TNF - Tuberculosis activa o latente - Otros criterios son aplicables |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1) Efficacy: ppPASI50 at week 16 2) Safety: Number of patients with drug-related AEs |
1) Eficacia: ppPASI50 en la semana 16 2) Seguridad: número de pacientes con efectos adversos asociados al medicamento |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) 16 weeks 2) 16 weeks |
1) 16 semanas 2) 16 semanas |
|
E.5.2 | Secondary end point(s) |
1) Treatment success defined as achieving a clinical response of 0 or 1=clear/almost clear via PPP Physicians Global Assessment (pppPGA) at week 16 2) ppPASI75 at week 16 3) Percent change from baseline in the ppPASI at week 16 |
1) Éxito del tratamiento, definido al alcanzar una respuesta clínica de 0 o 1 = remisión completa/casi completa a través de la evaluación global del médico de la PPP (pppPGA) en la semana 16 2) ppPASI75 en la semana 16 3) Porcentaje de cambio desde el periodo basal en la ppPASI en la semana 16 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 16 weeks 2) 16 weeks 3) 16 weeks |
1) 16 semanas 2) 16 semanas 3) 16 semanas |
|
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 3 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
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 |
Canada |
Denmark |
Germany |
Italy |
Spain |
Sweden |
|
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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 14 |