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    Summary
    EudraCT Number:2019-000833-37
    Sponsor's Protocol Code Number:VX18-445-110
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-09-17
    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 ConcernedNetherlands - Competent Authority
    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)
    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
    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 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 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
    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.3.2Product 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic fibrosis
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis
    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
    (Parts A and B) 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
    E.2.2Secondary objectives of the trial
    (Part A only)
    - To evaluate the long-term efficacy of VX-445/TEZ/IVA
    - To evaluate the pharmacodynamics (PD) of VX-445/TEZ/IVA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A
    Subjects transitioning from Study 104 must meet all of the following
    criteria to be eligible for Part A:
    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.

    Inclusion criteria for subjects resuming participation in Part A of this
    study after enrolling in another qualifying Vertex study include all of the
    criteria above AND the following criterion:
    6. Completed the ETT visit in another qualified Vertex study before or on
    same day as the Returning Visit in this study. If more than 30 days have
    elapsed since the ETT visit in the other qualified Vertex study, approval
    of the medical monitor is required.

    Part B
    Subjects who meet all of the following criteria will be eligible for Part B:
    1. Subject (or his or her legally appointed and authorized
    representative) will sign and date an ICF, 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 or Part A of this
    study.
    4. Meets at least 1 of the following criteria:
    • Completed study drug treatment in Part A, or
    • Had study drug interruption(s) in Part A, but without prematurely
    discontinuing study drug and completed study visits up to the last
    scheduled visit of the Treatment Period of Part A.
    5. Willing to remain on a stable CF treatment regimen (as defined in
    Protocol Section 9.5) through completion of study participation.
    Inclusion criteria for subjects resuming participation in Part B of this
    study after enrolling in another qualifying Vertex study include all of the
    criteria above AND the following criterion:
    6. Completed the ETT visit in another qualified Vertex study before or on
    same day as the Returning Visit in this study. If more than 30 days have
    elapsed since the ETT visit in the other qualified Vertex study, approval
    of the medical monitor is required.
    E.4Principal exclusion criteria
    Part A
    Subjects who meet any of the following criteria will NOT be eligible for
    Part A:
    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 Part A Day 1 Visit before receiving the first dose of study drug.
    3. History of intolerance to study drug 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.

    Subjects resuming participation in Part A of this study after enrolling in
    another qualifying Vertex study must not meet Exclusion Criteria 1
    through 3, and also must not meet any of the following criteria:
    5. Pregnant and nursing females. All female subjects must have a
    negative pregnancy test at the Returning Visit before receiving the first
    dose of study drug.
    6. History of intolerance to study drug that would pose an additional risk
    to the subject in the opinion of the investigator. If protocol-defined
    interruption criteria is met in another qualified
    Vertex study, then the subject must remain on study drug interruption
    until the subject meets criteria in Protocol Section 9.8 and receives
    approval by the medical monitor to resume study drug dosing in this
    study.
    7. Has received the first dose of study drug in the Treatment Period of
    another qualified Vertex study.
    8. Has access to commercially available VX-445/TEZ/IVA or is receiving
    managed-access-program-supplied VX-445/TEZ/IVA.
    9. Has departed this study more than once to participate in another
    qualified Vertex study.
    Part B
    Subjects who meet any of the following criteria will NOT be eligible for
    this study:
    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 Part B Day 1 Visit before receiving the first dose of study drug.
    3. History of intolerance to study drug 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 or the current 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.
    Subjects resuming participation in Part B of this study after enrolling in
    another qualifying Vertex study must not meet Exclusion Criteria 1
    through 4, and also must not meet any of the following criteria:
    5. Pregnant and nursing females. All female subjects must have a
    negative pregnancy test at the Returning Visit before receiving the first
    dose of study drug.
    6. History of intolerance to study drug that would pose an additional risk
    to the subject in the opinion of the investigator. If protocol-defined
    interruption criteria is met in another qualified Vertex study, then the
    subject must remain on study drug interruption until the subject meets
    criteria in Section 9.8 and receives approval by the medical monitor to
    resume study drug dosing in this study.
    7. Has received the first dose of study drug in the Treatment Period of
    another qualified Vertex study.
    8. Has access to commercially available VX-445/TEZ/IVA or is receiving
    managed-access-program-supplied VX-445/TEZ/IVA.
    9. Has departed this study more than once to participate in another
    qualified Vertex study.
    E.5 End points
    E.5.1Primary end point(s)
    (Parts A and B)
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A
    AEs: Continuous (signing of ICF until completion of study participation)
    Clinical laboratory values, vital signs, pulse oximetry: D1/Returning
    Visit; D15; wks 4,8,16,24, 36, 48,60,72,84,96; Part A Early Termination
    of Treatment (ETT)/Departing Visit; Part A Safety Follow-up (SFU) visit
    ECGs: D1/Returning visit; D15; wks4,8,24,48,72,96; Part A
    ETT/Departing visit; Part A SFU visit
    Part B
    AEs:Continuous (signing of ICF until completion of study participation)
    Clinical lab values,vital signs,pulse oxymentry:D1/Returning
    Visit;Wks12,24,36,48;Part B ETT/Departing Visit;Part B SFU Visit
    ECGs:D1/Returning visit;wks24,48;Part B ETT/Departing Visit;Part B SFU
    Visit
    E.5.2Secondary end point(s)
    (Part A only)
    - 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A only
    - ppFEV1: D1/Returning Visit; D15; weeks 4, 8, 16, 24, 36, 48, 60, 72,
    84, 96; ETT/Departing visit; Part A SFU visit
    - SwCl: D1/Returning Visit; D15; weeks 4, 8, 24, 48, 72, 96, ETT
    /Departing visit
    - BMI: D1/Returning Visit; D15; weeks 4, 8, 16, 24, 36, 48, 60, 72, 84,
    96; ETT/Departing visit; Part A SFU visit
    - BMI z-score: D1/Returning Visit; D15; weeks 4, 8, 16, 24, 36, 48, 60,
    72, 84, 96; ETT/Departing visit; Part A SFU visit
    - body weight: D1/Returning Visit; D15; weeks 4, 8, 16, 24, 36, 48, 60,
    72, 84, 96; ETT/Departing visit; Part A SFU visit
    - CFQ-R RD score: D1/Returning Visit; weeks 4, 8, 24, 48, 72, 96;
    ETT/Departing visit; Part A SFU visit
    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 Yes
    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
    2-part treatment period
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    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 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
    Belgium
    Canada
    Denmark
    France
    Germany
    Ireland
    Italy
    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
    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 months7
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days6
    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: 75
    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
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    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
    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 Decision2019-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-16
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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