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    Summary
    EudraCT Number:2019-000833-37
    Sponsor's Protocol Code Number:VX18-445-110
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-000833-37
    A.3Full title of the trial
    A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
    Studio di fase 3 in aperto per la valutazione della sicurezza ed efficacia a lungo termine della terapia combinata di VX-445 nei soggetti con fibrosi cistica eterozigoti per la mutazione F508del e per la mutazione della funzione residuale o di gating (genotipi F/G e F/RF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
    Studio per la valutazione della sicurezza ed efficacia a lungo termine della terapia combinata di VX-445
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberVX18-445-110
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04058366
    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 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 Address50 Northern Avenue
    B.5.3.2Town/ cityBoston
    B.5.3.3Post codeMA 02210-1862
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018776348789
    B.5.5Fax number0015105958183
    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/3/18/2116
    D.3 Description of the IMP
    D.3.1Product name100-mg VX-445 / 50-mg TEZ / 75- mg IVA FDC
    D.3.2Product code [VX-445/TEZ/IVA]
    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 INNTEZACAFTOR
    D.3.9.1CAS number 1152311-62-0
    D.3.9.2Current sponsor codeVX-661
    D.3.9.3Other descriptive nameTEZ
    D.3.9.4EV Substance CodeSUB188271
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.3.9.3Other descriptive nameIVA
    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 number75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNelexacaftor
    D.3.9.1CAS number 2216712-66-0
    D.3.9.2Current sponsor codeVX-445
    D.3.9.3Other descriptive nameVX-445
    D.3.9.4EV Substance CodeSUB185183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Kalydeco 150 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderVertex Pharmaceuticals (Ireland) Limited (MA n. EU/1/12/782/001-002)
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/008/556
    D.3 Description of the IMP
    D.3.1Product nameivacaftor
    D.3.2Product code [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 INNIVACAFTOR
    D.3.9.1CAS number 873054-44-5
    D.3.9.2Current sponsor codeVX-770
    D.3.9.3Other descriptive nameIVA
    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 number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic fibrosis
    Fibrosi cistica
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis
    Fibrosi Cistica
    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 20.0
    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 VX-445/tezacaftor (TEZ)/ivacaftor (IVA) in subjects with cystic fibrosis who are heterozygous for the F508del mutation and a gating (F/G) or residual function (F/RF) mutation
    Valutare la sicurezza e la tollerabilità a lungo termine di VX-445/tezacaftor (TEZ)/ivacaftor (IVA) in soggetti affetti da fibrosi cistica eterozigoti per la mutazione F508del e una mutazione di gating (F/G) o con funzione residua (F/RF)
    E.2.2Secondary objectives of the trial
    - To evaluate the long-term efficacy of VX-445/TEZ/IVA
    - To evaluate the pharmacodynamics (PD) of VX-445/TEZ/IVA
    • Valutare l’efficacia a lungo termine di VX-445/TEZ/IVA
    • Valutare la farmacodinamica (PD) di VX-445/TEZ/IVA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject (or his or her legally appointed and authorized representative) will sign and date an ICF (informed consent form), and, when appropriate, an assent form.
    2. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
    3. Did not withdraw consent from the parent study.
    4. Meets at least 1 of the following criteria:
    - Completed study drug treatment in the parent study.
    - Had study drug interruption(s) in the parent study, but without prematurely discontinuing study drug in the parent study and completed study visits up to the last scheduled visit of the Treatment Period of the parent study.
    5. Willing to remain on a stable CF treatment regimen through completion of study participation.
    1. Il soggetto (o il suo rappresentante legalmente nominato e autorizzato) firmerà e daterà un ICF e, ove opportuno, un modulo di assenso.
    2. Soggetto disposto e in grado di attenersi alle visite programmate, al piano di trattamento, alle restrizioni dello studio, agli esami di laboratorio, alle linee guida sui contraccettivi e ad altre procedure dello studio.
    3. Non ha ritirato il consenso a partecipare allo studio originario.
    4. Soddisfa almeno 1 dei criteri seguenti:
    • Ha completato il trattamento con il farmaco dello studio nello studio originario.
    • Ha avuto una o più interruzioni del farmaco dello studio nello studio originario, ma senza interrompere anticipatamente il farmaco dello studio nello studio originario, e ha completato le visite dello studio fino all’ultima visita programmata del periodo di trattamento dello studio originario.
    5. È disposto a restare su un regime di trattamento stabile per la FC fino al termine della partecipazione allo studio.
    E.4Principal exclusion criteria
    1. History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
    2. Pregnant and breast-feeding females. All female subjects, regardless of childbearing potential status, must have a negative pregnancy test at the Day 1 Visit before receiving the first dose of study drug.
    3. History of drug intolerance in the parent study that would pose an additional risk to the subject in the opinion of the investigator. (e.g., subjects with a history of allergy or hypersensitivity to the study drug).
    4. Current participation in an investigational drug study (other than the parent study). Participation in a non-interventional study (including observational studies, registry studies, and studies requiring blood collections without administration of study drug) and screening for another Vertex study is permitted.
    1. Anamnesi di qualsiasi patologia o condizione clinica che, a giudizio dello sperimentatore, potrebbe inficiare i risultati dello studio o rappresentare un rischio aggiuntivo per la somministrazione del farmaco dello studio al soggetto.
    2. Soggetti di sesso femminile in gravidanza e in allattamento. Tutti i soggetti di sesso femminile, indipendentemente se siano in età fertile o meno, devono presentare un test di gravidanza negativo alla visita del Giorno 1 prima di ricevere la prima dose di farmaco dello studio.
    3. Anamnesi di intolleranza al farmaco nello studio originario che rappresenterebbe un rischio aggiuntivo per il soggetto a giudizio dello sperimentatore (per es. soggetti con un’anamnesi di allergia o ipersensibilità al farmaco dello studio).
    4. Attuale partecipazione a uno studio su un farmaco sperimentale (diverso dallo studio originario). È consentita la partecipazione a uno studio non interventistico (compresi gli studi osservazionali, gli studi di registro e gli studi che richiedono prelievi di sangue senza somministrazione di un farmaco dello studio) e allo screening per un altro studio Vertex.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of long-term treatment with VX-445/TEZ/IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, and pulse oximetry.
    Sicurezza e tollerabilità del trattamento a lungo termine con VX-445/TEZ/IVA in base a eventi avversi (AE), valori clinici di laboratorio, elettrocardiogramma (ECG), segni vitali e pulsossimetria
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and tolerability assessments:
    a. AEs: Continuous (signing of ICF until completion of study participation)
    b. clinical laboratory values, vital signs, pulse oximetry: day 1; day 15; weeks 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; Early Termination of Treatment (ETT) visit (if applicable); Safety Follow-up (SFU) visit (if applicable)
    c. ECGs: day 1; day 15; weeks 4, 8, 24, 48, 72, 96; ETT visit (if applicable); SFU visit (if applicable)
    Valutazioni di sicurezza e tollerabilità:
    a. Eventi Avversi (EA): Continuativo (dalla firma del consenso fino al completamento della partecipazione allo studio)
    b. valori clinici di laboratorio, segni vitali, pulsossimetria: giorno 1; giorno 15; settimane 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; visita per la fine anticipata del trattamento (ETT) (se applicabile); Visita di Follow-up della sicurezza (SFU) (se applicabile)
    c. ECG: giorno 1; giorno 15; settimane 4, 8, 24, 48, 72, 96; visita di ETT (se applicabile); visita SFU (se applicabile)
    E.5.2Secondary end point(s)
    - Absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1)
    - Absolute change in sweat chloride (SwCl)
    - Absolute change in body mass index (BMI)
    - Absolute change in BMI z-score
    - Absolute change in body weight
    - Absolute change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain (RD) score
    • Cambiamento assoluto della percentuale del valore previsto di volume espiratorio forzato in 1 secondo (ppFEV1)
    • Cambiamento assoluto del cloruro nel sudore (SwCl)
    • Cambiamento assoluto dell’indice di massa corporea (BMI)
    • Cambiamento assoluto del punteggio z del BMI
    • Variazione assoluta del peso corporeo
    • Cambiamento assoluto del punteggio relativo al dominio respiratorio (RD) del questionario revisionato per la fibrosi cistica (CFQ-R)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - ppFEV1: day 1; day 15; weeks 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; ETT visit (if applicable); SFU visit (if applicable)
    - SwCl: day 1; day 15; weeks 4, 8, 24, 48, 72, 96, ETT visit (if applicable)
    - BMI: day 1; day 15; weeks 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; ETT visit (if applicable); SFU visit (if applicable)
    - BMI z-score: day 1; day 15; weeks 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; ETT visit (if applicable); SFU visit (if applicable)
    - body weight: day 1; day 15; weeks 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; ETT visit (if applicable); SFU visit (if applicable)
    - CFQ-R RD score: day 1; weeks 4, 8, 24, 48, 72, 96; ETT visit (if applicable); SFU visit (if applicable)
    - ppFEV1: giorno 1; giorno 15; settimane 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; visita ETT (se applicabile); visita SFU (se applicabile)
    - SwCl: giorno 1; giorno 15; settimane 4, 8, 24, 48, 72, 96, ETT visit (se applicabile)
    - BMI: giorno 1; giorno 15; settimane 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; visita ETT (se applicabile); visita SFU (se applicabile)
    - punteggio z del BMI: giorno 1; giorno 15; settimane 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; visita ETT (se applicabile); visita SFU (se applicabile)
    - peso corporeo: giorno 1; giorno 15; settimane 4, 8, 16, 24, 36, 48, 60, 72, 84, 96; visita ETT (se applicabile); visita SFU (se applicabile)
    - punteggio per CFQ-R RD : giorno 1; settimane 4, 8, 24, 48, 72, 96; visita ETT (se applicabile); visita SFU (se applicabile)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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 Information not present in EudraCT
    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
    Canada
    United States
    Belgium
    Denmark
    France
    Germany
    Ireland
    Italy
    Netherlands
    Spain
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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: 75
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 175
    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
    Subject under age incapable of giving consent personally
    soggetti di età inferiore a quella che consente di dare personalmente il consenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 250
    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
    nessuno
    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 Decision2019-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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