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    Summary
    EudraCT Number:2014-004782-24
    Sponsor's Protocol Code Number:PRM-151-202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-004782-24
    A.3Full title of the trial
    A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
    Ensayo clínico de fase II para evaluar la eficacia de PRM-151 en sujetos con fibrosis pulmonar idiopática (FPI).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.
    Estudio para probar la seguridad del medicamento intravenoso PRM-151 y comprobar como el PRM-151 actúa en el cuerpo y la sangre de personas con Fibrosis Pulmonar Idiopática (FPI) - una enfermedad en la que el tejido pulmonar se daña y cicatriza haciendo difícil la respiración
    A.4.1Sponsor's protocol code numberPRM-151-202
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPromedior, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPromedior Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVenn Life Sciences
    B.5.2Functional name of contact pointJudith Pool
    B.5.3 Address:
    B.5.3.1Street AddressHoofdstraat 15
    B.5.3.2Town/ cityHoogeveen
    B.5.3.3Post code7902 EA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31524712456
    B.5.5Fax number31524712457
    B.5.6E-mailjudith.pool@venncro.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/12/1020
    D.3 Description of the IMP
    D.3.2Product code PRM-151
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRM-151
    D.3.9.1CAS number 1387453-03-3
    D.3.9.2Current sponsor codePRM-151
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis (IPF)
    Fibrosis Pulmonar Idiopática
    E.1.1.1Medical condition in easily understood language
    Deadly lung disease with unknown cause in which the lung tissue that is needed to get oxygen into the blood becomes thick and stiff, which leads to difficulties with breathing
    Enfermedad pulmonar mortal sin causa conocida en la que el tejido pulmonar que se necesita para llevar oxígeno a la sangre se vuelve grueso y rígido, lo que dificulta la respiración
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment for IPF.
    Determinar la magnitud del efecto de PRM-151 en comparación con placebo en el cambio desde el inicio hasta la semana 28 en el FVC% (valor de la capacidad vital forzada) medio previsto, agrupando a los sujetos con una dosis estable de pirfenidona o nintedanib con sujetos que no reciben otro tratamiento para la FPI
    E.2.2Secondary objectives of the trial
    ?Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in:
    -normal lung parenchyma as quantified on HRCT imaging analysis, pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment for IPF.
    -mean FVC% predicted, separately in subjects on a stable dose of pirfenidone or nintedanib and separately in subjects not on other treatments for IPF.
    -normal lung parenchyma as quantified on HRCT imaging analysis, separately in subjects on a stable dose of pirfenidone or nintedanib and in subjects not on other treatments for IPF.
    ?Assess the tolerability and safety of PRM-151 in subjects with IPF through Week 28
    ?Assess the ability of PRM-151 to reduce disease-related events associated with mortality.
    ?Determine the effect size of PRM-151 relative to placebo on:
    -pulmonary function in addition to mean change in FVC% predicted.
    -6 minute walk distance.
    -DLCO.
    Determinar la magnitud del efecto de PRM-151 en comparación con placebo desde el inicio hasta la semana 28 en:
    · el parénquima pulmonar normal cuantificado mediante TC de alta resolución (TCAR), agrupando a los sujetos con una dosis estable de pirfenidona o nintedanib con sujetos que no reciben otro tratamiento para la FPI.
    · el FVC% medio previsto, estudiando por separado a los sujetos con una dosis estable de pirfenidona o nintedanib y a los sujetos que no reciben otro tratamiento para la FPI.
    · el parénquima pulmonar normal cuantificado mediante TC de alta resolución (TCAR), estudiando por separado a los sujetos con una dosis estable de pirfenidona o nintedanib y a los sujetos que no reciben otro tratamiento para la FPI.
    ? Evaluar la tolerabilidad y seguridad de PRM-151 en sujetos con FPI hasta la semana 28.
    ? Evaluar la capacidad de PRM-151 para reducir los acontecimientos relacionados con la enfermedad asociados a la mortalidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is aged 40-80 years.
    2.Subject has IPF satisfying the ATS/ERS/JRS/ALAT diagnostic criteria (Raghu, Collard et al. 2011).
    In the absence of a surgical lung biopsy, HRCT must be ?consistent with UIP? defined as meeting either criteria A, B, and C, or criteria A and C, or criteria B and C below:
    A.Definite honeycomb lung destruction with basal and peripheral predominance.
    B.Presence of reticular abnormality AND traction bronchiectasis consistent with fibrosis, with basal and peripheral predominance.
    C.Atypical features are absent, specifically nodules and consolidation. Ground glass opacity, if present, is less extensive than reticular opacity pattern.
    3.If on pirfenidone or nintedanib, subject must have been on a stable dose of pirfenidone or nintedanib for at least 3 months without increase in FVC% predicted on two consecutive PFTs, including screening PFTs. Subjects may not be on both pirfenidone and nintedanib.
    4.If not currently receiving pirfenidone or nintedanib, subject must have been off pirfenidone or nintedanib for ? 4 weeks before baseline.
    5.Subject has a FVC ? 50% and ? 90% of predicted.
    6.Subject has a DLCO ? 25% and ? 90% of predicted.
    7.Minimum distance on 6MWT of 150 meters.
    8.Subject has a forced expiratory volume in 1 second (FEV1)/FVC ratio > 0.70.
    9.Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ? 55 years or 12 months if > 55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence.
    10.Subject has a life expectancy of at least 9 months
    11.Subject, according to the investigator?s best judgment, can comply with the requirements of the protocol.
    12.Subject has provided written informed consent to participate in the study.
    1. El sujeto tendrá entre 40 y 80 años de edad.
    2. El sujeto presentará una FPI que cumplirá los criterios diagnósticos de ATS/ERS/JRS/ALAT (Raghu, Collard et al. 2011).
    En ausencia de una biopsia pulmonar quirúrgica, la TCAR deberá ?corresponderse con NIU (neumonía intersticial usual)?, definida como el cumplimiento de los siguientes criterios A, B y C, los criterios A y C, o los criterios B y C:
    A. Destrucción pulmonar definida en patrón de panal de abeja con predominio basal y periférico.
    B. Presencia de anomalía reticular Y bronquiectasia de tracción correspondiente a fibrosis, con predominio basal y periférico.
    C. Presencia de anomalía reticular Y bronquiectasia de tracción correspondiente a fibrosis, con predominio basal y periférico.
    3. Si está recibiendo pirfenidona o nintedanib, el sujeto deberá haber estado recibiendo una dosis estable de pirfenidona o nintedanib durante al menos 3 meses sin aumento del FVC% previsto en dos PFP consecutivas, incluidas las PFP de la selección. Los sujetos no podrán recibir pirfenidona y nintedanib simultáneamente.
    4. Si no está recibiendo actualmente pirfenidona o nintedanib, el sujeto deberá haber respetado un periodo de lavado de pirfenidona o nintedanib de ? 4 semanas antes del inicio del estudio.
    5. El sujeto presentará un FVC ? 50 % y ? 90 % del valor previsto.
    6. El sujeto presentará una DLCO ? 25 % y ? 90 % del valor previsto.
    7. Distancia mínima de 150 metros en la PM6M.
    8. El sujeto presentará una proporción del volumen espiratorio forzado en 1 segundo (FEV1)/FVC > 0,70.
    9. Las mujeres en edad fértil (MEF), definidas como mujeres sexualmente maduras, que no hayan sido esterilizadas quirúrgicamente o que no sean post-menopáusicas durante al menos 24 meses consecutivos si tienen ? 55 años o 12 meses si tienen > 55 años, deberán presentar una prueba de embarazo en suero negativa en el plazo de cuatro semanas antes de la primera dosis del fármaco del estudio y deberán emplear métodos anticonceptivos adecuados durante el estudio. Entre las formas aprobadas de métodos anticonceptivos se incluyen anticonceptivos orales o Depo-Provera con un método de barrera adicional (diafragma con gel espermicida o preservativos con espermicida), métodos de barrera dobles (diafragma con gel espermicida y preservativos con espermicida), vasectomía de la pareja y abstinencia total.
    10. El sujeto presentará una esperanza de vida de al menos 9 meses.
    11. El sujeto, de acuerdo con el criterio del investigador, será capaz de cumplir los requisitos del protocolo.
    12. El sujeto ha proporcionado un consentimiento informado por escrito para participar en el estudio.
    E.4Principal exclusion criteria
    1.Subject has emphysema ? 50% on HRCT or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
    2.Subject has a history of cigarette smoking within the previous 3 months.
    3.Subject has received investigational therapy for IPF within 4 weeks before baseline.
    4.Subject is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks of baseline.
    5.Subject received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline.
    6.Subject has a history of a malignancy within the previous 5 years, with the exception of basal cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring prior to 5 years must be considered cured, inactive, and not under current treatment.
    7.Subject has any concurrent condition other than IPF that, in the Investigator?s opinion, is unstable and/or would impact the likelihood of survival for the study duration or the subject?s ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study.
    8.Subject has baseline resting oxygen saturation of < 89% on room air or supplemental oxygen.
    9.Subjects that are unable to refrain from use of the following:
    a)Short acting bronchodilators on the day of and within 12 hours of pulmonary function, DLCO, and 6 minute walk assessments.
    b)Long acting bronchodilators on the day of and within 24 hours of these assessments.
    10.Subject has a known post bronchodilator (short acting beta agonist [SABA] ? albuterol or salbutamol) increase in FEV1 of >10% and in FVC of >7.5%.
    1. El sujeto presenta un enfisema ? 50 % en la TCAR o la extensión de enfisema es mayor que la extensión de la fibrosis de acuerdo con los resultados obtenidos de la TCAR más reciente.
    2. El sujeto tiene antecedentes de tabaquismo durante los 3 meses anteriores.
    3. El sujeto ha recibido tratamiento en fase de investigación para la FPI durante las 4 semanas anteriores al inicio del estudio.
    4. El sujeto está recibiendo corticosteroides sistémicos equivalentes a prednisona > 10 mg/día o equivalente en las 2 semanas anteriores al inicio del estudio.
    5. El sujeto recibió azatioprina, ciclofosfamida o ciclosporina A durante las 4 semanas anteriores al inicio del estudio.
    6. El sujeto tiene antecedentes de tumor maligno durante los 5 años anteriores, a excepción de neoplasias cutáneas de células basales. Además, un diagnóstico de tumores o enfermedades de carácter maligno que hayan aparecido hace más de 5 años deberán considerarse curadas, inactivas y no en tratamiento actualmente.
    7. El sujeto presenta enfermedades concurrentes diferentes de la FPI que, a criterio del investigador, son inestables o podrían afectar la probabilidad de supervivencia durante el transcurso del estudio o a la capacidad del sujeto para completar el estudio tal como este ha sido diseñado, o bien que pudieran influir en la seguridad o eficacia de las evaluaciones incluidas en el estudio.
    8. El sujeto presenta una saturación de oxígeno en reposo inicial de < 89 % con aire ambiental u oxígeno complementario.
    9. Los sujetos que no puedan prescindir del uso de:
    a) Broncodilatadores de acción corta el día de las pruebas de función pulmonar, DLCO y la marcha de 6 minutos, y durante las 12 horas posteriores a las mismas.
    b) Broncodilatadores de acción prolongada el día de dichas pruebas y durante las 24 horas posteriores a estas evaluaciones.
    10. El sujeto presenta un incremento conocido de FEV1 > 10 % y de FVC > 7,5 % después del uso de broncodilatadores (beta agonista de acción corta [SABA] ? albuterol o salbutamol).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean change in FVC % predicted from Baseline to Week 28.
    El criterio de valoración principal es el cambio medio en el FVC% previsto desde el inicio hasta la semana 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 28 of treatment
    Semana 28 de tratamiento
    E.5.2Secondary end point(s)
    Structural Imaging:
    ?Mean change from Baseline to Week 28 in total lung volume and volume of parenchymal features on HRCT (in ml and % of total lung volume) representative of interstitial lung abnormalities (ILA) including ground glass density, reticular changes, and honeycombing, using quantitative imaging software.
    ?Mean change from Baseline to Week 28 in volume of parenchymal features on HRCT (in ml and % of total lung volume) representative of normal lung (non-ILA), including normal and low attenuation areas, using quantitative imaging software.
    ?Correlation between mean change from Baseline to Week 28 in FVC % predicted and mean change from Baseline to Week 28 in total lung volume and volume of parenchymal features on HRCT (in ml and % of total lung volume) representative of interstitial lung abnormalities (ILA), including ground glass density, reticular changes, and honeycombing by quantitative imaging software.

    Safety: Tolerability/safety will be assessed over the 28 week study period by the following parameters:
    ?Incidence of AEs.
    ?Incidence of serious adverse events (SAEs).
    ?Incidence of respiratory AEs and SAEs.
    ?Proportion of subjects discontinuing study drug due to AEs.
    ?Change from Baseline in hematology and serum chemistries.
    ?All cause mortality.
    ?Mortality due to respiratory deterioration.

    Disease related events associated with mortality: The number of ?respiratory decline? events over the 28 week study period as defined below:
    ?Unscheduled visits to a healthcare professional for respiratory status deterioration.
    ?Urgent care visit for respiratory status deterioration.
    ?Hospitalization due to a worsening or exacerbation of respiratory symptoms.
    All ?respiratory decline? events will be further characterized according to the definitions of IPF related acute exacerbation, as proposed by an expert committee sponsored by the IPF Clinical Research Network and the National Heart Lung and Blood Institute (NHLBI) (Collard, Moore et al. 2007) and applied by (Collard, Yow et al. 2013)
    ?Acute onset of symptoms (< 30 days in duration)
    ?New radiographic abnormalities (bilateral ground glass or consolidation on HRCT with no pneumothorax or pleural effusion)
    ?The absence of an identified infectious etiology by routine clinical practice
    ?Exclusion of alternative causes by routine clinical practice, including:
    a.Left heart failure
    b.Pulmonary embolism
    c.Identifiable cause of acute lung injury

    Pulmonary Function Tests
    ?Proportion (%) of subjects with a decline in FVC% predicted of ? 5% and ? 10% from Baseline to Week 28.
    ?Proportion (%) of subjects with a decline in FVC in ml of ? 100 ml and ? 200 ml from Baseline to Week 28.
    ?Proportion of subjects with an increase in FVC % predicted of ? 5% and ? 10% from Baseline to Week 28.
    ?Proportion of subjects with an increase in FVC in ml of ?100 ml and ? 200 ml from Baseline to Week 28.
    ?Proportion of subjects with stable disease by FVC %, defined as a change in FVC % predicted of <5% from Baseline to Week 28.
    ?Proportion of subjects with stable disease by FVC in ml, defined as a change in FVC of < 100ml from Baseline to Week 28.
    ?Mean change from Baseline to Week 28 in % predicted diffusion capacity of carbon monoxide (DLCO).
    ?Change in 6-minute walk distance, in meters, from Baseline to Week 28.

    Exploratory:
    Other Weeks
    ?Examine the change from Baseline at Weeks 4, 8, 12, 16, 20, and 24 for the FVC % predicted, FVC in ml, and 6MWT distance

    Structural Imaging
    ?Transitions from Baseline to Week 28 between all categories of lung features (normal, ground glass density, reticular changes, honeycombing, and mild, moderate, and severe low attenuation areas) by quantitative imaging software.
    ?Correlation of transitions between categories of lung features by quantitative imaging and changes in FVC% predicted.
    ?Correlation of transitions between categories of lung features by quantitative imaging and changes in DLCO.
    ?Impact of inspiratory effort on results of HRCT quantitative imaging.

    Patient Reported Outcomes
    ?Change in Patient Reported Outcomes as measured by King?s Brief Interstitial Lung Disease Questionnaire (K-BILD) and Leicester Cough Questionnaire (LCQ) from Baseline to Week 28.

    Biomarkers
    ?Changes in serum and cellular biomarkers and response according to baseline genetic characteristics: including but not limited to TLR3, L412F polymorphism, and MUC5B promoter polymorphism.
    Diagnóstico por imagen estructural:
    ? Cambio medio desde el inicio hasta la semana 28 en el volumen pulmonar total y el volumen de las características del parénquima mediante TCAR (en ml y % del volumen pulmonar total) que sean representativas de anomalías pulmonares intersticiales (API), incluyendo opacidades en vidrio esmerilado, alteraciones reticulares y patrones en panal de abeja, empleando software de diagnóstico por imagen cuantitativo.
    ? Cambio medio desde el inicio hasta la semana 28 en el volumen de las características del parénquima mediante TCAR (en ml y % del volumen pulmonar total) que sean representativas de un pulmón normal (no API), incluyendo áreas de atenuación normal y baja, empleando software de diagnóstico por imagen cuantitativo.
    ? Correlación entre el cambio medio desde el inicio hasta la semana 28 en el FVC% previsto y el cambio medio desde el inicio hasta la semana 28 en el volumen pulmonar total y el volumen de las características del parénquima mediante TCAR (en ml y % del volumen pulmonar total) que sean representativas de anomalías pulmonares intersticiales (API), incluyendo opacidades en vidrio esmerilado, alteraciones reticulares y patrones en panal de abeja, empleando software de diagnóstico por imagen cuantitativo.
    ? Seguridad: La tolerabilidad/seguridad se evaluará durante las 28 semanas de duración del estudio mediante los siguientes parámetros:
    ? Incidencia de AA.
    ? Incidencia de acontecimientos adversos graves (AAG).
    ? Incidencia de AA y AAG respiratorios.
    ? Porcentaje de sujetos que interrumpen el fármaco del estudio debido a AA.
    ? Cambio desde el inicio en los parámetros hematológicos y la bioquímica sérica.
    ? Mortalidad por cualquier causa.
    ? Mortalidad debida a deterioro respiratorio.
    ? Acontecimientos relacionados con la enfermedad asociados a mortalidad: La cantidad de acontecimientos de ?deterioro respiratorio? durante las 28 semanas de duración del estudio de acuerdo con las siguientes definiciones:
    ? Visitas no programadas a un profesional sanitario en relación con el deterioro del estado respiratorio.
    ? Visita al servicio de urgencias debida al deterioro del estado respiratorio.
    ? Hospitalización debida a un empeoramiento o exacerbación de los síntomas respiratorios.
    Todos los acontecimientos de ?deterioro respiratorio? se caracterizarán según las definiciones de exacerbación aguda relacionada con FPI, de acuerdo con las recomendaciones de un comité de expertos patrocinado por la Red de Investigación Clínica de FPI y el Instituto Nacional del Corazón, los Pulmones y la Sangre (NHLBI, Clinical Research Network and the National Heart Lung and Blood Institute) (Collard, Moore et al. 2007) y aplicadas por (Collard, Yow et al. 2013)
    ? Aparición aguda de los síntomas (< 30 días de duración)
    ? Nuevas anomalías radiográficas (opacidad bilateral en vidrio esmerilado o consolidación en TCAR sin neumotórax o derrame pleural)
    ? Ausencia de una etiología infecciosa identificada por medio de la práctica clínica habitual
    ? Exclusión de causas alternativas por medio de la práctica clínica habitual, entre las que se incluyen:
    a. insuficiencia cardíaca izquierda
    b. Embolia pulmonar
    c. Causa no identificable de lesión pulmonar aguda
    ? Pruebas de función pulmonar
    ? Porcentaje (%) de sujetos con un descenso del FVC% previsto ? 5 % y ? 10 % desde el inicio hasta la semana 28.
    ? Porcentaje (%) de sujetos con un descenso del FVC en ml ? 100 ml y ? 200 ml desde el inicio hasta la semana 28.
    ? Porcentaje de sujetos con un aumento del FVC% previsto ? 5 % y ? 10 % desde el inicio hasta la semana 28.
    ? Porcentaje de sujetos con un aumento del FVC en ml ? 100 ml y ? 200 ml desde el inicio hasta la semana 28.
    ? Porcentaje de sujetos con enfermedad estable según el FVC%, definido como un cambio en el FVC% previsto < 5 % desde el inicio hasta la semana 28.
    ? Porcentaje de sujetos con enfermedad estable según el FVC en ml, definido como un cambio en el FVC < 100 ml desde el inicio hasta la semana 28.
    ? Cambio medio desde el inicio hasta la semana 28 en el % de la capacidad de difusión del monóxido de carbono prevista (DLCO).
    ? Cambio en la prueba de la marcha de 6 minutos, en metros, desde el inicio hasta la semana 28.
    Exploratorios:
    ? Otras semanas
    ? Examinar el cambio desde el inicio hasta las semanas 4, 8, 12, 16, 20 y 24 en el FVC% previsto, el FVC en ml y la prueba de la marcha de 6 minutos.
    ? Diagnóstico por imagen estructural
    ? Transiciones desde el inicio hasta la semana 28 entre todas las categorías de características pulmonares (normal, opacidad en vidrio esmerilado, alteraciones reticulares, patrón en panal de abeja y áreas de atenuación baja leve, moderada y grave) mediante software de diagnóstico por imagen cuantitativo.
    ? Correlación de las transiciones entre las categorías de características pulmonares mediante un diagnóstico por imagen cuantitativo y cambios en el FVC% previsto.
    E.5.2.1Timepoint(s) of evaluation of this end point
    With every visit after randomisation and at week 28
    En cada visita después de la aleatorización y a la semana 28
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Germany
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial 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
    Ultima Visita Ultimo Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 59
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 117
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After completion of study treatment through Week 24, all subjects may receive PRM-151 10 mg/kg IV infusion over 60 minutes days 1,3, and 5, and then one infusion every 4 weeks for up to an additional 96 weeks in an open label study extension.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
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