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    EudraCT Number:2020-001263-85
    Sponsor's Protocol Code Number:SAV006-05
    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:2021-05-24
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001263-85
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP)
    Studio clinico randomizzato, in doppio cieco, controllato verso placebo, con soluzione di molgramostim per nebulizzatore da inalare una volta al giorno in soggetti adulti con proteinosi alveolare polmonare autoimmune (aPAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.
    Studio clinico in cui ai pazienti affetti da proteinosi alveolare polmonare autoimmune verrà somministrato per via inalatoria il molgramostim per nebulizzatore
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberSAV006-05
    A.5.4Other Identifiers
    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 SponsorSAVARA APS
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSavara ApS
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressSlotsmarken 17, 1. th
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code2970
    B.5.4Telephone number+4579301414
    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 numberOD/106/12
    D.3 Description of the IMP
    D.3.1Product nameMolgramostim 300 µg nebulizer solution
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Nebuliser 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 INN00201600
    D.3.9.1CAS number 99283-10-0
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB09040MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 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 placeboNebuliser 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
    Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
    Proteinosi alveolare polmonare autoimmune (aPAP)
    E.1.1.1Medical condition in easily understood language
    Pulmonary Alveolar Proteinosis, commonly known by the acronym PAP, is a rare lung disease characterized by the build-up of proteinaceous material in the alveoli (air sacs) of the lungs.
    La Proteinosi alveolare polmonare autoimmune, comunemente conosciuta con l'acronimo aPAP, è una malattia rara caratterizzata dalla crescita di materiale proteinoso negli alveoli del polmone
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10037316
    E.1.2Term Pulmonary alveolar proteinosis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate the efficacy of Molgramostim 300 µg nebulizer solution compared to placebo after 24-week treatment
    Indagare sull’efficacia di MOL rispetto al placebo dopo 24 settimane di trattamento
    E.2.2Secondary objectives of the trial
    - Investigate the safety of Molgramostim 300 µg nebulizer solution compared to placebo after 24-week treatment
    - Investigate the efficacy of Molgramostim 300 µg nebulizer solution compared to placebo after 48-week treatment
    - Investigate the safety of Molgramostim 300 µg nebulizer solution compared to placebo after 48-week treatment
    - Investigate the efficacy of Molgramostim 300 µg nebulizer solution after 96-week treatment
    - Investigate the safety of Molgramostim 300 µg nebulizer solution after 96-week treatment
    -Indagare sulla sicurezza di MOL rispetto al placebo dopo 24 settimane di trattamento
    -Indagare sull’efficacia di MOL rispetto al placebo dopo 48 settimane di trattamento
    -Indagare sulla sicurezza di MOL rispetto al placebo dopo 48 settimane di trattamento
    -Indagare sull’efficacia di MOL dopo 96 settimane di trattamento
    -Indagare sulla sicurezza di MOL dopo 96 settimane di trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be > = 18 years of age, at the time of signing the informed consent. Specific for Japan; Subject must be > = 20 years of age, at the time of signing the informed consent.
    2. A serum anti-GM-CSF autoantibody test result confirming autoimmune PAP.
    3. History of PAP, based on examination of a lung biopsy, bronchoalveolar lavage (BAL) cytology, or a high-resolution computed tomogram (HRCT) of the chest.
    4. DLCO 70% predicted or lower at the Screening and Baseline visits.
    5. Change in % predicted DLCO of < 15% points during the screening period.
    6. Demonstrated functional impairment in the treadmill exercise test (defined as a peak MET < or =8).
    7. Willing and able to come off supplemental oxygen use prior to and during the treadmill exercise test, the DLCO assessment, and the arterial blood gas sampling.
    8. Resting SpO2 >85% during 15 minutes without use of supplemental oxygen at the Screening visits.
    9. Male or female
    10. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    a. Male subjects: Males agreeing to use condoms during and until 30 days after last dose of trial treatment, or males having a female partner who is using adequate contraception as described below.
    b. Female subjects: Females who have been post-menopausal* for >1 year, or females of childbearing potential** after a confirmed menstrual period using a highly efficient method of contraception (i.e. a method with <1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence***), during and until 30 days after last dose of trial treatment. Females of childbearing potential must have a negative serum pregnancy test at the screening visits, and a negative urine pregnancy test at Baseline visit (Visit 3) and must not be lactating.
    * Post-menopausal is defined as no menses for at least 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
    ** A female is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile.
    Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
    ***Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
    11. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified in the protocol as judged by the Investigator.
    1. Il soggetto deve avere almeno 18 anni di età, al momento della firma del consenso informato. Specifico per il Giappone; Il soggetto deve avere un'età almeno 20 anni, al momento della firma del consenso informato.
    2. Un risultato del test sierico per autoanticorpi anti-GM-CSF che conferma PAP autoimmune.
    3. Anamnesi di PAP, basata sull'esame di una biopsia polmonare, citologia da lavaggio broncoalveolare (BAL) o tomografia computerizzata ad alta risoluzione (HRCT) del torace.
    4. DLCO previsto pari a 70% o inferiore alla visita di screening e al basale.
    5. Variazione della percentuale del DLCO previsto minore del 15% durante il periodo di screening.
    6. Documentato peggioramento funzionale nel test da sforzo su tapis roulant (definito come un picco MET minore o uguale a 8)
    7. Paziente disponibile e in grado di interrompere l'uso supplementare di ossigeno prima e durante il test da sforzo sul tapis roulant, la valutazione DLCO e il dosaggio dei gas sul sangue arterioso.
    8. SpO2 a riposo > 85% per 15 minuti senza uso di ossigeno supplementare durante la visita di screening.
    9. Maschio o femmina
    10. L'uso di contraccettivi da parte di uomini o donne deve essere conforme alle normative locali riguardanti i metodi di contraccezione per coloro che partecipano a studi clinici.
    a. Soggetti di sesso maschile: maschi che accettano di usare il preservativo durante e fino a 30 giorni dopo l'ultima dose del trattamento in studio, o maschi che hanno una partner donna che sta usando un metodo contraccettivo adeguato come descritto di seguito.
    b. Soggetti di sesso femminile: donne in post-menopausa * da più di 1 anno o donne in età fertile ** dopo un ciclo mestruale confermato che utilizzano un metodo contraccettivo altamente efficace (ovvero un metodo con una percentuale di fallimento inferiore all’1% come la contraccezione ormonale combinata, la contraccezione ormonale a base di solo progesterone, dispositivo intrauterino, sistema di rilascio ormonale intrauterino, legatura delle tube bilaterale, partner vasectomizzato, astinenza sessuale ***), durante e fino a 30 giorni dopo l'ultima dose del trattamento in studio. Le donne in età fertile devono avere un test di gravidanza su siero negativo alla visita di screening e un test di gravidanza sulle urine negativo alla visita basale (Visita 3) e non devono essere in allattamento.
    * La post-menopausa è definita come assenza di mestruazioni per almeno 12 mesi senza una causa medica alternativa. Un livello elevato di ormone follicolo stimolante (FSH) nell'intervallo postmenopausale può essere utilizzato per confermare uno stato postmenopausale nelle donne che non utilizzano contraccezione ormonale o terapia ormonale sostitutiva. Tuttavia, in assenza di 12 mesi di amenorrea, una singola misurazione dell'FSH è insufficiente.
    ** Una donna è considerata potenzialmente fertile a seguito del menarca e fino a quando non diventa postmenopausale a meno che non sia permanentemente sterile.
    I metodi di sterilizzazione permanenti comprendono l'isterectomia, la salpingectomia bilaterale e l'ovariectomia bilaterale.
    *** L'astinenza sessuale è considerata un metodo altamente efficace solo se definita come astensione dal rapporto eterosessuale durante l'intero periodo di rischio associato al trattamento in studio. L'affidabilità dell'astinenza sessuale deve essere valutata in relazione alla durata della sperimentazione clinica e allo stile di vita preferito e abituale del soggetto.
    11. Capacità di fornire il consenso informato firmato come descritto nell'Appendice 1 che include la conformità ai requisiti e alle restrizioni elencati nel modulo di consenso informato (ICF) e in questo protocollo.
    12. Disponibilità e capacità di rispettare le visite programmate, il piano di trattamento, i test di laboratorio e le altre procedure specificate nel protocollo secondo il giudizio dello Sperimentatore.
    E.4Principal exclusion criteria
    1. Diagnosis of hereditary or secondary PAP, or a metabolic disorder of surfactant production.
    2. WLL performed within 3 months prior to baseline.
    3. Requirement for WLL at screening or baseline.
    4. GM-CSF treatment within 6 months prior to baseline.
    5. Treatment with rituximab within 6 months prior to baseline.
    6. Treatment with plasmapheresis within 6 weeks months prior to baseline.
    7. Treatment with any investigational medicinal product within 5 halflives or 3 months (whichever is longer) prior to baseline.
    8. Previously randomized in this trial.
    9. History of allergic reactions to GM-CSF or any of the excipients in the nebulizer solution.
    10. Inflammatory or autoimmune disease of a severity that necessitates significant (e.g. more than 10 mg/day systemic prednisolone) immunosuppression.
    11. Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product.
    12. History of, or present, myeloproliferative disease or leukemia.
    13. Apparent pre-existing concurrent pulmonary fibrosis.
    14. Acute or unstable cardiac or pulmonary disease that may be aggravated by exercise.
    15. Known active infection (viral, bacterial, fungal, or mycobacterial) that may affect the efficacy evaluation in the trial.
    16. Physical disability or other condition that precludes safe and adequate exercise testing.
    17. Any other serious medical condition which in the opinion of the Investigator would make the subject unsuitable for the trial.
    18. Pregnant, planning to become pregnant during the trial, or breastfeeding woman.
    1. Diagnosi di PAP ereditaria o secondaria, o disturbo metabolico della produzione di surfattante.
    2. WLL eseguita entro 3 mesi precedenti al basale.
    3. Necessità di WLL allo screening o al basale.
    4. Trattamento con GM-CSF entro 6 mesi precedenti al basale.
    5. Trattamento con rituximab entro 6 mesi precedenti al basale.
    6. Trattamento con plasmaferesi entro 6 settimane precedenti al basale.
    7. Trattamento con qualsiasi medicinale sperimentale entro 5 emivite o 3 mesi (a seconda del periodo più lungo) prima del basale.
    8. Precedentemente randomizzato in questo studio.
    9. Anamnesi di reazioni allergiche al GM-CSF o ad uno degli eccipienti presenti nella soluzione per nebulizzatore.
    10. Malattia infiammatoria o autoimmune di una gravità tale da necessitare un'immunosoppressione significativa (ad es. Più di 10 mg / giorno di prednisolone per via sistemica).
    11. Precedente esperienza di effetti collaterali gravi e senza una chiara spiegazione durante la somministrazione di aerosol con qualsiasi tipo di medicinale.
    12. Anamnesi di, o presenza di, malattia mieloproliferativa o leucemia.
    13. Apparente fibrosi polmonare concomitante preesistente.
    14. Malattia cardiaca o polmonare acuta o instabile che può essere aggravata dall'esercizio.
    15. Infezione attiva nota (virale, batterica, fungina o micobatterica) che può influire sulla valutazione dell'efficacia nello studio.
    16. Disabilità fisica o altra condizione che preclude un test da sforzo sicuro e adeguato.
    17. Qualsiasi altra condizione medica grave che, a parere dello Sperimentatore, renderebbe il soggetto inidoneo allo studio.
    18. Paziente incinta, che sta pianificando una gravidanza durante lo studio o che allatta.
    E.5 End points
    E.5.1Primary end point(s)
    Change in % predicted DLCO from baseline to Week 24
    Cambiamento in percentuale del DLCO previsto dal basale alla settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    settimana 24
    E.5.2Secondary end point(s)
    • Change in SGRQ Total from baseline to Week 24
    • Change in SGRQ Activity from baseline to Week 24
    • Change in EC (expressed as peak METs) from baseline to Week 24
    • Cambiamento del punteggio SGRQ totale dal basale alla settimana 24
    • Cambiamento del punteggio dell'attività SGRQ dal basale alla settimana 24
    • Cambiamento dell'EC (espresso come picco METs) dal basale alla settimana 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 24
    settimana 24
    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 Yes
    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. 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Korea, Democratic People's Republic of
    Korea, Republic of
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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 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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 160
    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 the trial, the Investigator will advise trial subjects on access to appropriate and available treatment options.
    Dopo il completamento dello studio, lo sperimentatore consiglierà ai soggetti le opzioni di trattamento più appropriate e disponibili.
    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 Decision2020-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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