E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
Enfermeda pulmonar intersticial fibrosante progresiva (EPI-FP) |
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E.1.1.1 | Medical condition in easily understood language |
Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
Enfermeda pulmonar intersticial fibrosante progresiva (EPI-FP) |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
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 | 10066393 |
E.1.2 | Term | Respiratory bronchiolitis-associated interstitial lung disease |
E.1.2 | System Organ Class | 100000004855 |
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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 main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have completed (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247) |
El objetivo principal es evaluar la tolerabilidad y seguridad a largo plazo del tratamiento con nintedanib oral en pacientes con enfermedad pulmonar intersticial fibrosante progresiva (EPI-FP) que han completado (y no suspendieron prematuramente la medicación del estudio en) el ensayo de Fase III, INBUILD® (ensayo 1199.147) |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment. 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 3. Women of childbearing potential (WOCBP) must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information |
1. Pacientes hombres o mujeres que han completado el estudio INBUILD® según lo planeado y que no suspendieron prematuramente el tratamiento ciego. 2. Consentimiento informado por escrito firmado y fechado, según ICH-GCP y la legislación local antes de la inclusión en el ensayo. 3. Mujeres con potencial para quedarse embarazas deben continuar utilizando métodos anticonceptivos altamente efectivos según ICh M3 (R2) que resulten en una tasa de error baja menor que 1% por año cuando se usan de forma consistente y correcta, además de un método de barrera, durante 28 días previos y hasta 3 meses después de la administración de nintedanib. En la información al paciente se encuantra una lista de métodos anticonceptivos que cumplen estos criterios. |
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E.4 | Principal exclusion criteria |
1. Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator’s benefit-risk assessment remains favourable. 2. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial 3. Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator’s judgement. 4. Previous enrolment in this trial. 5. Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes the patient an unreliable trial participant or unlikely to complete the trial. 6. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. |
1. Cualquier enfermedad que pueda poner en riesgo al paciente cuando participe en el este ensayo. Reconsiderar cuidadosamente todos los criterios de exclusión del ensayo INBUILD®. Sin embargo, los pacientes pueden participar en el ensayo aunque hayan cumplido algún criterio de exclusión durante la participación en el ensayo INBUILD®, si la evaluación beneficio-riesgo del investigador permanece favorable. 2. Pacientes que deban o quieran continuar tomando medicamentos restringidos o cualquier medicameeto que se considere que pueda interferir con el funcionamiento seguro del ensayo. 3. Pacientes que no cumplan con la medicación del ensayo o con las visitas en el ensayo previo (INBUILD®), según el criterio del investigador. 4. Participación previa en este ensayo. 5. Abuso crónico de alcohol o drogas o cualquier trastoro que, en opinión del investigador, haga que el paciente no sea un participante fiable o que sea probable que no complete el ensayo. 6. Mujeres embarazadas, en periodo de lactancia, o que planeen quedarse embarazadas durante el ensayo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. The primary endpoint is the incidence of overall adverse events over the course of this extension trial. |
1 El criterio de valoración principal es la incidencia de acontecimientos adversos generales durante el transcurso de este ensayo de extensión. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. End of trial |
1. Fin del ensayo |
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E.5.2 | Secondary end point(s) |
1. No secondary efficacy endpoints are defined. |
1. No se definen variables de evaluación de eficacia secundarias. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. No secondary efficacy endpoints are defined. |
1. No se definen variables de evaluación de eficacia secundarias. |
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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 | No |
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) | 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.8.3 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
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 |
Belgium |
Canada |
Chile |
China |
France |
Germany |
Italy |
Japan |
Korea, Republic of |
Poland |
Russian Federation |
Spain |
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
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LVLS |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 18 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 18 |