E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IDIOPATHIC PULMONARY FIBROSIS |
FIBROSIS PULMONAR IDIOPÁTICA |
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E.1.1.1 | Medical condition in easily understood language |
IDIOPATHIC PULMONARY FIBROSIS |
FIBROSIS PULMONAR IDIOPÁTICA |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 evaluate safety of lebrikizumab compared with placebo in patients with IPF ? To evaluate efficacy of lebrikizumab compared with placebo in patients with IPF, as measured by progression-free survival (PFS). |
Evaluar Lebrikizumab comparado con placebo en pacientes con fibrosis pulmonar idiopática determinado por la supervivencia libre de progresión (SLP)) |
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E.2.2 | Secondary objectives of the trial |
? To evaluate the efficacy of lebrikizumab compared with placebo in patients with IPF on the basis of pulmonary function, diffusion capacity, death, non-elective hospitalization from any cause, and acute IPF exacerbations ? To evaluate the efficacy of lebrikizumab compared with placebo in patients with IPF on the basis of distance walked in 6 minutes and patient reported health-related quality of life. |
? Evaluar la eficacia de lebrikizumab comparado con placebo en pacientes con FPI basándose en la función pulmonar, capacidad de difusión, muerte, ingreso hospitalario no programado por cualquier causa, y agravamiento de la FPI aguda ? Evaluar la eficacia de lebrikizumab comparado con placebo en pacientes con FPI basándose en la distancia recorrida en 6 minutos y calidad de vida relacionada con la salud |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult patient, >/= 40 years of age - Have a definite IPF diagnosis according to the 2011 ATS/ARS/JRS/ALAT consensus statement on IPF within the previous 4 years from time of screening and confirmed at baseline - Forced vital capacity (FVC) >/= 40% and </=90% predicted at screening - Stable baseline lung function as evidenced by a difference of < 10% in FVC (L) measurements between screening and randomization - Diffusion capacity of the lung for carbon monoxide >/= 25% and </= 90% predicted at screening - Ability to walk >/= 100 meters unassisted in 6 minutes. |
Edad > 40 años en la visita 1. Diagnóstico definitivo de FPI evidente de acuerdo con la declaración de 2011 ATS/ERS/JRS/ALAT consensus de FPI en los 4 años previos desde el momento de la selección y confirmado en el periodo basal. FVC > 40% y <90% del valor previsto en la selección. Función pulmonar basal estable tal como se demuestra por una diferencia de <10% en las determinaciones de FVC (L) entre la selección y el Día 1/Visita 2 antes de la aleateorización. Capacidad de difusión del pulmón para el monóxido de carbono ( DLCO) > 25% y < 90% del valor previsto en la selección Capacidad para caminar > 100 metros sin ayuda en 6 minutos. |
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E.4 | Principal exclusion criteria |
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection - Evidence of other known causes of interstitial lung disease (ILD) - Lung transplant expected within 12 months of screening - Evidence of clinically significant lung disease other than IPF - Post bronchodilator forced expiratory volume in 1 second (FEV1)/FVC ratio < 0.7 at screening - Positive bronchodilator response, evidenced by an increase of >/= 12% predicted and 200 mL increase in FEV1 or FVC - Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction < 35% - Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening - Known current malignancy or current evaluation for potential malignancy - Listeria monocytogenes infection or active parasitic infections within 6 months prior to randomization. - Active tuberculosis requiring treatment within 12 months of screening - Known immunodeficiency, including but not limited to HIV infection - Past use of any anti-IL-13 or anti-IL-14/IL-13 therapy, including lebrikizumab - Evidence of acute or chronic hepatitis or known liver cirrhosis. |
Antecedentes de una reacción alérgica severa o reacción anafiláctica a un agente biológico o hipersensibilidad conocida a un componente de la inyección de lebrikizumab. Evidencia de otras causas conocidas de enfermedad pulmonar intersticial Previsión de trasplante pulmonar en los 12 meses siguientes a la selección. Evidencia de enfermedad pulmonar clínicamente significativa diferente a FPI. Relación del volumen espiratorio forzado después de broncodilatador en 1 segundo (FEV1)/FVC relación <0,7 en la selección. Respuesta al broncodilatador positiva demostrada por un aumento de > 12% prevista y aumento de 200 mL en FEV1 o FVC. Insuficiencia cardíaca crónica Class IV de la New York Heart Association o pruebas históricas de fracción de eyección ventricular izquierda <35%. Ingreso hospitalario debido a agravamiento de FPI en las cuatro semanas previas a, o durante, la selección. Tumor maligno conocido en curso o evaluación en curso de una posible neoplasia maligna. Infección por Listeria monocytogenes o infección activa por parásitos en los 6 meses previos al Día 1/Visita 2 Tuberculosis activa que requiere tratamiento en los 12 meses previos a la selección Inmunodeficiencia conocida, tal incluida pero no limitada acomo la infección por el VIH. Uso previo de cualquier tratamiento anti?IL-13 o anti?IL-4/IL-13, incluyendoso lebrikizumab Evidencia Pruebas de cirrosis hepática conocida o hepatitis aguda o crónica |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free survival |
Progresion libre de enfermedad |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
up to 2.5 years |
Hasta 2.5 años |
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E.5.2 | Secondary end point(s) |
1. Change in pulmonary function (FVC, [L]) 2. Change in diffusion capacity of the lung for carbon monoxide 3. Change in Quality of Life measurements 4. Time from randomization to death or non-elective hospitalization from any cause 5. Change in six minute walk test 6. Time from randomization to first event of acute IPF exacerbation 7. Safety: Incidence of adverse events |
Cambio anualizado en FVC (L) ? Tiempo desde la aleatorización hasta el primer descenso con respecto al valor basal de > 10% en el FVC (L) ? Tiempo desde la aleatorización hasta el primer descenso con respecto al valor basal de > 15% en DLCO (mL CO/min-1/mmHg-1) ? Cambio desde el valor basal hasta la Semana 52 en el instrumento A para valorar la Calidad de Vida en IPF (ATADATAQ-IPF) ? Tiempo desde la aleateatorización hasta la muerte o ingreso hospitalario no programado por cualquier causa. ? Cambio desde el valor basal hasta la Semana 52 en la prueba de marchacaminar de durante seis minutos (6MWT) ? Tiempo desde la aleatorización hasta el primer episodio de agravamiento de FPI agudo. ? Incidencia de eventos adversos |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. up to 2.5 years 2. from baseline to end of treatment (up to 2.5 years) 3. from baseline to Week 52 4. up to 2.5 years 5. from baseline to Week 52 6. up to 2.5 years 7. up to 2.5 years |
1. Hasta 2.5 años 2. Desde baseline hasta fin de tratamiento (2,5 años) 3. Desde Baseline hasta semana 52 4. Hasta 2.5 años 5. Desde Baseline hasta semana 52 6.Hasta 2.5 años 7. Hasta 2.5 años |
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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 | Yes |
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 | 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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
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 |
France |
Germany |
Italy |
Japan |
Mexico |
Peru |
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
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'LVLS' |
El final del estudio se define como la fecha en que se produce la última visita del último paciente |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |