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    Summary
    EudraCT Number:2013-000604-41
    Sponsor's Protocol Code Number:VX12-809-105
    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:2013-10-08
    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 number2013-000604-41
    A.3Full title of the trial
    A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
    Estudio de extensión de fase 3 para evaluar la seguridad y la eficacia del tratamiento a largo plazo con lumacaftor en combinación con ivacaftor en sujetos de 12 años o más con fibrosis quística, homocigóticos o heterocigóticos para la mutación F508del-CFTR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs
    Estudio en personas con Fibrosis Quística (una rara enfermedad pulmornar hereditaria) para evaluar la eficacia a largo plazo y la seguridad de la combinación de dos fármacos experimentales.
    A.4.1Sponsor's protocol code numberVX12-809-105
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/121/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVertex Pharmaceuticals Incorporated
    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 supportVertex Pharmaceuticals Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVertex Pharmaceuticals Incorporated
    B.5.2Functional name of contact pointClinical Trials and Medical Info
    B.5.3 Address:
    B.5.3.1Street Address130 Waverly Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139-4242
    B.5.3.4CountryUnited States
    B.5.4Telephone number+ 18776348789
    B.5.5Fax number+ 15105958183
    B.5.6E-mailmedicalinfo@vrtx.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/3/10/761
    D.3 Description of the IMP
    D.3.1Product namelumacaftor/ivacaftor 200mg/125mg tablets
    D.3.2Product code VX-809 / VX-770
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlumacaftor
    D.3.9.1CAS number 936727-05-8
    D.3.9.2Current sponsor codeVX-809
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIVACAFTOR
    D.3.9.1CAS number 873054-44-5
    D.3.9.2Current sponsor codeVX-770
    D.3.9.4EV Substance CodeSUB33103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 2
    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/3/10/761
    D.3 Description of the IMP
    D.3.1Product namelumacaftor/ivacaftor 200mg/83mg tablet
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlumacaftor
    D.3.9.1CAS number 936727-05-8
    D.3.9.2Current sponsor codeVX-809
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIVACAFTOR
    D.3.9.1CAS number 873054-44-5
    D.3.9.2Current sponsor codeVX-770
    D.3.9.4EV Substance CodeSUB33103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number83
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 3
    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/3/8/556
    D.3 Description of the IMP
    D.3.1Product nameivacaftor 125mg tablet
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIVACAFTOR
    D.3.9.1CAS number 873054-44-5
    D.3.9.2Current sponsor codeVX-770
    D.3.9.4EV Substance CodeSUB33103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
    Fibrosis Quística en pacientes homocigóticos o heterocigóticos para la mutación F508del-CFTR
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis
    Fibrosis Quística
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long term safety and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the for the F508del-CFTR mutation
    Evaluar la seguridad y tolerabilidad a largo plazo de lumacaftor en combinación con ivacaftor en pacientes con fibrosis Quística (FQ) los cuales son homocigóticos o heterocigóticos para la mutación F508del-CFTR
    E.2.2Secondary objectives of the trial
    To evaluate the long term efficacy and durability of lumacaftor in combination with ivacaftor for subjects in the Treatment Cohort

    To evaluate the post treatment safety and tolerability of lumacaftor in combination with ivacaftor for subjects in the Observational Cohort
    Evaluar la eficacia y la durabilidad a largo plazo de lumacaftor combinado con ivacaftor en los sujetos de la cohorte de tratamiento.
    Evaluar la seguridad y la tolerabilidad después del tratamiento de lumacaftor combinado con ivacaftor en los sujetos de la cohorte de observación
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Subjects entering the Part A Treatment Cohort must have completed 24 weeks of study drug treatment in Study 103 or Study 104 and wish to enroll in the Part A Treatment Cohort.
    ? Subjects entering the Part A Observational Cohort must have completed 24 weeks of study drug treatment in Study 103 or Study 104, but do not wish or do not qualify to enroll in the Part A Treatment Cohort.
    ? Treatment Cohort Subjects entering the Part B Treatment Cohort must have completed 56 days of study drug treatment in Cohort 4 of Study 102 and wish to enroll in the Part B Treatment Cohort.
    ? Willing to remain on a stable CF medication regimen through the end of study (Treatment Cohort only).
    ? Los sujetos que entren en la cohorte de tratamiento de la parte A deberán haber completado 24 semanas de tratamiento con el fármaco del estudio en los estudios 103 o 104 y quieran participar en la cohorte de tratamiento de la parte A..
    ? Los sujetos que entren en la cohorte de observación de la parte A deberán haber completado 24 semanas de tratamiento con el fármaco del estudio en los estudios 103 o 104, pero no quieren o no son elegibles para participar en la cohorte de tratamiento de la parte A.
    ? Tratamiento de cohorte de los sujetos que participan en la cohorte de tratamiento de la parte B deberán haber completado 56 días de tratamiento con el fármaco en estudio en la cohorte 4 del estudio 102, y quieran participar en la cohorte de tratamiento de la parte B.
    ? Disposición para continuar con una pauta de medicación para la FQ estable hasta el final del estudio (sólo la cohorte de tratamiento).
    E.4Principal exclusion criteria
    ? Any comorbidity or lab abnormality that might confound the results of the study or pose an additional risk in administering study drug to the subject.
    ? Pregnant and nursing females, sexually active subjects of reproductive potential who are not willing to follow the contraception requirements.
    ? History of drug intolerance in prior study that would pose an additional risk to the subject.
    ? History of poor compliance with study drug and/or procedures in prior study.
    ? Subjects may not participate in an investigational drug study until the completion of this study.
    ? Cualquier proceso concomitante o anomalía analítica quepueda confundir los resultados del estudio o suponer un riesgo adicional al administrar el fármaco del estudio al sujeto
    ? Mujeres embarazadas y lactantes, sujetos sexualmente activos y en edad fértil que no estén dispuestos a cumplir los requisitos anticonceptivos indicados.
    ? Antecedentes de intolerancia al fármaco en el estudio previo que supongan un riesgo adicional para el sujeto
    ? Participación en otro ensayo de un fármaco en investigación hasta la finalización de éste estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Safety of long term treatment of lumacaftor in combination with ivacaftor based on adverse events (AEs), clinical laboratory values (serum chemistry, hematology, coagulation studies, and urinalysis), standard digital electrocardiograms (ECGs), vital signs, and pulse oximetry.
    Seguridad del tratamiento a largo plazo con lumacaftor combinado con ivacaftor basada en los acontecimientos adversos (AA), los valores de los análisis clínicos (bioquímica sérica, hematología, pruebas de coagulación y análisis de orina), los electrocardiogramas (ECG) digitales habituales, las constantes vitales y la pulsioximetría.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through week 100
    Sobre la semana 100
    E.5.2Secondary end point(s)
    For the Treatment Cohort: Relative change from baseline in percent predicted forced expiratory volume in 1 second (FEV1), Absolute change from baseline in percent predicted FEV1, Absolute change from baseline in body mass index (BMI), Number of pulmonary exacerbations starting from the previous study (Part A only), Absolute change from baseline in Cystic Fibrosis Questionnaire Revised (CFQ R) respiratory domain score, Absolute change in BMI z score (for Part A only), Absolute change from baseline in body weight, Rate of change in percent predicted FEV1, Time-to-first pulmonary exacerbation including pulmonary exacerbations in the previous study (Part A only), Event of having at least 1 pulmonary exacerbation including pulmonary
    exacerbations in the previous study (Part A only)
    For the Observational Cohort: Safety, as determined by serious adverse events (SAEs).
    Para la Cohorte de tratamiento:Cambio relativo del porcentaje del volumen espiratorio forzado en 1 segundo (FEV1) previsto respecto al basal,Cambio absoluto del porcentaje del FEV1 previsto respecto al basal,Cambio absoluto del índice de masa corporal (IMC) respecto al basal,Número de exacerbaciones pulmonares iniciadas desde el estudio anterior (sólo en la parte A),Cambio absoluto de la puntuación del dominio respiratorio del cuestionario revisado de la fibrosis quística (CFQ-R) respecto a la basal,Cambio absoluto de la puntuación z del IMC (sólo en la parte A),Cambio absoluto del peso corporal respecto al basal,Tasa de variación en volumen espiratorio forzado en 1 segundo (FEV1), Tiempo hasta la primera exacerbación pulmonar, incluidas las exacerbaciones pulmonares en el estudio anterior (sólo en la parte A),Aparición de al menos una exacerbación pulmonar, incluidas las exacerbaciones pulmonares en el estudio anterior (sólo en la parte A)
    Para la Cohorte de observación:Seguridad, determinada mediante los acontecimientos adversos graves (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through week 100
    Sobre la semana 100
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different dosage of the same medicial product
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    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
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Ireland
    Italy
    Netherlands
    Spain
    Sweden
    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 Last Visit Last Subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 389
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 389
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 611
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children, age 12-17 years old, are included in the study.
    Niños, de edad comprendida entre 12 y 17 años, serán incluidos en el estudio
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 1000
    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)
    None.
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-07
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