E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 | 18.1 |
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 |
|
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 main objective of this trial is to assess the efficacy and safety of BI 655066 compared to ustekinumab and placebo in patients with moderate to severe chronic plaque psoriasis. |
El objetivo principal de este estudio es evaluar la eficacia y seguridad de BI 655066 en comparación con ustekinumab y placebo en pacientes con psoriasis en placas crónica de moderada a grave. |
|
E.2.2 | Secondary objectives of the trial |
Additionally, this trial will assess PK and the emergence of anti-drug antibodies, as well as the influence of study treatment on disease specific biomarkers, psoriatic arthritis, and metabolic risk factors. |
Además, en este estudio se evaluarán la PK y la aparición de anticuerpos antifármaco (ADA) así como de qué manera el uso de BI 655066 puede influir en los niveles de expresión génica y proteica y en los marcadores de proteínas específicos de la enfermedad. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female patients with age >= 18 years at screening,
Women of childbearing potential must be ready and able to use highly effective methods of birth control,
Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization): a. Have an involved body surface area (BSA) >= 10% and b. Have a Psoriasis Area and Severity Index (PASI) score >= 12 and c. Have a static Physician Global Assessment (sPGA) score of >= 3.
Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
Must be a candidate for treatment with Stelara® (ustekinumab) according to local label. |
Pacientes varones o mujeres de edad ? 18 años en el momento de la inclusión
Las mujeres potencialmente fértiles* deben querer y poder utilizar métodos anticonceptivos altamente eficaces
Tener un diagnóstico de psoriasis en placas crónica (con o sin artritis psoriásica) durante al menos 6 meses antes de la primera administración del fármaco del estudio.
Tener psoriasis en placas crónica de moderada a grave con o sin artritis psoriásica en los periodos de selección y basal (aleatorización): a. tener una BSA afectada ? 10 % y, b. tener una puntuación PASI ? 12 y, c. tener una puntuación sPGA ? 3.
Debe ser candidato para el tratamiento sistémico o fototerapia para el tratamiento de la psoriasis, a juicio del investigador.
Debe ser candidato para el tratamiento con Stelara® (ustekinumab) según la ficha técnica local. |
|
E.4 | Principal exclusion criteria |
Patients with: a. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular), b. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium), c. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigators judgment,
Previous exposure to BI 655066, Previous exposure to ustekinumab (Stelara®),
Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted),
Use of any restricted medication , or any drug considered likely to interfere with the safe conduct of the study,
Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, aneurysm removal, stomach ligation),
Known chronic or relevant acute infections including active tuberculosis, HIV or viral hepatitis,
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix,
Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value at the screening visit outside the reference range that is in the opinion of the investigator, is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data,
History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients,
Women who is pregnant, nursing, or who plans to become pregnant while in the trial, |
Pacientes con a. formas de psoriasis no en placas (incluida en gotas, eritrodérmica o pustulosa). b. Psoriasis actual inducida por fármacos (incluida una exacerbación de la psoriasis de los betabloqueantes, antagonistas del calcio o litio). c. Enfermedades inflamatorias activas en curso distintas de la psoriasis y la artritis psoriásica que podrían confundir las evaluaciones del estudio según el criterio del investigador.
Exposición previa a BI 655066. Exposición previa a ustekinumab (Stelara®).
Pacientes incluidos actualmente en otro estudio de investigación o que hayan transcurrido menos de 30 días (desde la selección) desde que concluyó otro estudio de investigación (se permite la participación en estudios observacionales).
Uso de cualquier medicación restringida o de algún fármaco que se considere probable que interfiera con la realización seguro del estudio.
Cirugía mayor realizada en las 12 semanas anteriores a la aleatorización o programada en los 12 meses después de la selección (p. ej., artroplastia de cadera, eliminación de aneurisma, ligadura de estómago).
Infecciones crónicas o infecciones agudas relevantes incluida la tuberculosis activa, el HIV o la hepatitis vírica
Cualquier neoplasia maligna documentada o sospecha de la misma o antecedentes de neoplasia maligna en los 5 años anteriores a la selección, salvo el carcinoma espinocelular o basocelular tratado o el carcinoma in situ del cuello uterino.
Prueba de una afección actual o previa, enfermedad (incluidos el abuso del alcohol y las drogas) aparte de psoriasis, intervención quirúrgica (por ejemplo, trasplante de órganos), hallazgo de una exploración clínica (incluidas la constantes vitales y el ECG), o valor analítico en la visita de selección fuera del intervalo de referencia que, en opinión del investigador, sea clínicamente significativo y haría que el participante en el estudio fuera poco fiable a la hora de cumplir el protocolo o realizar el estudio, pondría en peligro la seguridad del paciente, o pondría en peligro la calidad de los datos.
Antecedentes de alergia/hipersensibilidad a un agente biológico de administración sistémica o a sus excipientes. Mujeres embarazadas, en periodo de lactancia o que prevean quedarse embarazadas durante el periodo del estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1: Achievement of >= 90% reduction from baseline PASI score (PASI 90) at Week 16
2: Achievement of a sPGA score of clear or almost clear at Week 16 |
1: Alcanzar una reducción ? 90 % con respecto a la puntuación PASI inicial (PASI 90) en la semana 16.
2: Alcanzar una puntuación sPGA de remisión total o casi total en la semana 16. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: week 16 from first trial medication
2: week 16 from first trial medication |
1: semana 16 tras la primera medicación
2: semana 16 tras la primera medicación |
|
E.5.2 | Secondary end point(s) |
1: Achievement of >= 75% reduction from baseline PASI score (PASI 75) at Week 12
2: Achievement of a sPGA score of clear or almost clear at Week 12
3: Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 16
4: Achievement of >= 90% reduction from baseline PASI score (PASI 90) at Week 52
5: Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 52
6: Change from baseline in psoriasis symptoms evaluated using the total score on the PSS at week 16
7: Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16
8: Achievement of total score on the PSS of 0 at week 16 |
1- Alcanzar una reducción ? 75 % con respecto a la puntuación PASI inicial (PASI 75) en la semana 12. 2- Alcanzar una puntuación sPGA de remisión total o casi total en la semana 12. 3- Alcanzar una reducción del 100 % con respecto a la puntuación PASI inicial (PASI 100) en la semana 16. 4- Alcanzar una reducción ? 90 % con respecto a la puntuación PASI inicial (PASI 90) en la semana 52. 5- Alcanzar una reducción del 100 % con respecto a la puntuación PASI inicial (PASI 100) en la semana 52. 6- Cambio con respecto a la situación basal en los síntomas de psoriasis, evaluados utilizando la puntuación total en la Escala de síntomas de la psoriasis (PSS) en la semana 16. 7- Alcanzar una puntuación en el Índice de calidad de vida en dermatología (DLQI) de 0 o 1 en la semana 16. 8- Alcanzar una puntuación total en la PSS de 0 en la semana 16. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: week 12
2: week 12
3: week 16
4: week 52
5: week 52
6: week 16
7: week 16
8: week 16 |
1: semana 12
2: semana 12
3: semana 16
4: semana 52
5: semana 52 |
|
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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | 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 | 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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
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 |
Austria |
Belgium |
Canada |
France |
Germany |
Italy |
Mexico |
Netherlands |
Poland |
Portugal |
Spain |
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
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 12 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 20 |