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    Summary
    EudraCT Number:2016-005230-30
    Sponsor's Protocol Code Number:SPX-101-CF-201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 number2016-005230-30
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS)
    Studio di fase II randomizzato, in doppio cieco, controllato con placebo per valutare l¿efficacia e la sicurezza di SPX-101 in soluzione per inalazione in soggetti affetti da fibrosi cistica (Studio HOPE-1: Hydration for Optimal Pulmonary Effectiveness)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.
    Uno studio di ricerca per valutare se SPX-101 possa essere utile e sicuro per persone con fibrosi cistica
    A.3.2Name or abbreviated title of the trial where available
    HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness
    Studio HOPE-1: Hydration for Optimal Pulmonary Effectiveness
    A.4.1Sponsor's protocol code numberSPX-101-CF-201
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorSPYRYX BIOSCIENCES, 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 supportSpyryx Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpyryx Biosciences, Inc.
    B.5.2Functional name of contact pointClinical Development Operations
    B.5.3 Address:
    B.5.3.1Street Address801-10 Capitola Drive
    B.5.3.2Town/ cityDurham
    B.5.3.3Post code27713 NC
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019198999399
    B.5.5Fax number0018666333180
    B.5.6E-mailcontact@spyryxbio.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSPX-101
    D.3.2Product code [SPX-101]
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSPX-101
    D.3.9.2Current sponsor codeSPX-101
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation vapour, solution
    D.8.4Route of administration of the placeboInhalation use
    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
    A genetic disorder affecting mostly the lungs causing difficulty breathing and frequent lung infections
    Disturbo genetico che riguarda principalmente i polmoni che causa difficolt¿ a respirare e frequenti infezioni polmonari
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of SPX-101 in subjects with CF
    Valutare l'efficacia di SPX-101 in soggetti con fibrosi cistica(FC)
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of SPX-101 in subjects with CF
    - To assess the extent of systemic exposure of SPX-101 in a subset of subjects
    - Valutare la sicurezza e la tollerabilit¿ di SPX-101 in soggetti affetti da FC
    - Valutare l¿entit¿ dell¿esposizione sistemica a SPX-101 in un sottogruppo di soggetti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Ability to provide written, personally signed, and dated informed consent
    - Ability to self-administer the investigational product
    - Diagnosis of cystic fibrosis as determined by the 2008 Cystic Fibrosis Foundation Consensus Guidelines
    - Percent predicted forced expiratory volume in 1 second (ppFEV1) between 40.0% and 80.0% for cohort 1 and between 50.0% and 80% for cohort 2
    - Stable CF lung disease
    -Capacità di fornire il consenso informato scritto, firmato e datato personalmente
    -Capacità di auto-somministrarsi il prodotto sperimentale
    - Diagnosi di fibrosi cistica, determinata in base alle Linee guida di consenso per la diagnosi del 2008 della Cystic Fibrosis Foundation
    -ppFEV1 (Percent predicted forced expiratory volume in 1 second) compreso tra il 40,0% e l'80,0% per la coorte 1 e tra il 50.0% e l'80% per la coorte 2
    - Quadro patologico polmonare della FC stabile
    E.4Principal exclusion criteria
    - BMI < 18 kg/m2
    - Use of a Cystic fibrosis transmembrane conductance regulator (CFTR) corrector or potentiator during the study or within 60 days before screening
    - The presence of significant unstable comorbidities within 28 days before screening
    - IMC < 18 kg/m2
    -Uso di un correttore o di un potenziatore di CFTR durante lo studio o nei 60 giorni precedenti lo screening
    -Presenza di comorbilità instabili significative nei 28 giorni precedenti lo screening
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1)
    Variazione dal basale in ppFEV1(percent predicted forced expiratory volume in 1 second )
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4
    settimana 4
    E.5.2Secondary end point(s)
    - The change from baseline in ppFEV1
    - The change from baseline in Forced expiratory volume in one second
    (FEV1), Forced Vital Capacity (FVC) and percent predicted forced vital
    capacity (ppFVC)
    - The change from Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
    -variazione dal basale in ppFEV1
    -variazione dal basale in "Forced expiratory volume in one second"(FEV1), "Forced Vital Capacity (FVC) e "percent predicted forced vital
    capacity (ppFVC)
    - variazione dal basale nel questionario della fibrosi cistica rivisto (CFQ-R)
    E.5.2.1Timepoint(s) of evaluation of this end point
    ppFEV1 at weeks 1 and 2
    FEV1, FVC and ppFVC at weeks 1, 2, and 4
    CFQ-R at week 4
    ppFEV1 alle settimane 1 e 2
    FEV1, FVC e ppFVC alle settimane 1,2 e 4
    CFQ-R alla settimana 4
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    France
    Italy
    Portugal
    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 being the last follow up phone call
    LVLS all'ultimo follow up telefonico
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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 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: 90
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 90
    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)
    Patients will continue as per standard of care.
    i pazienti continueranno le cure standard
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Cystic Fibrosis Society, ECFS-CTN coordinating centre
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
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