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    Summary
    EudraCT Number:2022-001951-18
    Sponsor's Protocol Code Number:INS1009-203
    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:2022-11-17
    Trial 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 number2022-001951-18
    A.3Full title of the trial
    An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
    Studio di estensione in aperto volto a valutare la sicurezza, la tollerabilità e l'efficacia dell'uso a lungo termine di Treprostinil Palmitil in polvere per inalazione in partecipanti affetti da ipertensione arteriosa polmonare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Extension Study to Evaluate Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
    Studio di estensione in aperto per valutare l'uso a lungo termine di Treprostinil Palmitil in polvere per inalazione in partecipanti affetti da ipertensione arteriosa polmonare
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberINS1009-203
    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 SponsorINSMED 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 supportInsmed Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInsmed Switzerland GmbH
    B.5.2Functional name of contact point Regulatory Affairs Manager EU
    B.5.3 Address:
    B.5.3.1Street AddressGrafenauweg 10
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041763823300
    B.5.6E-mailurnell.greaves@insmed.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 nameTreprostinil Palmitil Inhalation Powder
    D.3.2Product code [INS1009]
    D.3.4Pharmaceutical form Inhalation powder
    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 INNTREPROSTINIL PALMITIL
    D.3.9.1CAS number 1706528-83-7
    D.3.9.2Current sponsor codeINS1009
    D.3.9.4EV Substance CodeSUB21168
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Yes
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTreprostinil Palmitil Inhalation Powder
    D.3.2Product code [INS1009]
    D.3.4Pharmaceutical form Inhalation powder
    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 INNTREPROSTINIL PALMITIL
    D.3.9.1CAS number 1706528-83-7
    D.3.9.2Current sponsor codeINS1009
    D.3.9.4EV Substance CodeSUB21168
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 Yes
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTreprostinil Palmitil Inhalation Powder
    D.3.2Product code [INS1009]
    D.3.4Pharmaceutical form Inhalation powder
    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 INNTREPROSTINIL PALMITIL
    D.3.9.1CAS number 1706528-83-7
    D.3.9.2Current sponsor codeINS1009
    D.3.9.4EV Substance CodeSUB21168
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    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 Yes
    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 powder
    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
    Participants with Pulmonary Arterial Hypertension
    Partecipanti con ipertensione arteriosa polmonare
    E.1.1.1Medical condition in easily understood language
    Participants with high blood pressure in the arteries of the lungs
    Partecipanti con pressione alta nelle arterie dei polmoni
    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 PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201, INS1009-202 and other lead-in studies of TPIP in participants with PAH.
    Valutare la sicurezza e la tollerabilità dell'uso a lungo termine di TPIP in partecipanti con PAH provenienti dagli
    studi INS1009-201, INS1009-202 e da altri studi di lead-in su TPIP in partecipanti con PAH.
    E.2.2Secondary objectives of the trial
    -To evaluate the effect of the long-term use of TPIP on exercise capacity in participants with PAH.
    - To evaluate the effect of the long-term use of TPIP on blood biomarkers of disease severity in participants with PAH.
    -To evaluate the effect of the long-term use of TPIP on the mortality risk in participants with PAH.
    -To evaluate the effect of the long-term use of TPIP on the clinical status of participants with PAH.
    To evaluate the effect of the long-term use of TPIP on the clinical worsening rate in participants with PAH.
    -To further evaluate the PK profile of the long-term use of TPIP in participants with PAH.
    - Valutare l'effetto dell'uso a lungo termine di TPIP sulla capacità di esercizio in partecipanti con PAH
    - Valutare gli effetti dell'uso a lungo termine di TPIP sui biomarcatori ematici della gravità della malattia in partecipanti con PAH
    - Valutare l'effetto dell'uso a lungo termine di TPIP sul rischio di mortalità in partecipanti con PAH
    - Valutare l'effetto dell'uso a lungo termine di TPIP sullo stato clinico di partecipanti con PAH
    - Valutare l'effetto dell'uso a lungo termine di TPIP sul tasso di peggioramento clinico in partecipanti con PAH
    - Valutare ulteriormente il profilo PK dell'uso a lungo termine di TPIP in partecipanti con PAH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants who completed the end of treatment visit in Study INS1009-201, Study INS1009-202, or any other lead-in PAH TPIP study. Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
    2. Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-201, Study INS1009-202, or any other lead-in PAH TPIP in study.
    3. Capable of giving signed informed consent.
    1. Partecipanti che hanno completato la visita di fine trattamento dello Studio INS1009-201, dello Studio INS1009-202 o di qualsiasi altro studio di lead-in su TPIP per PAH. I partecipanti per i quali lo studio OLE non era disponibile al momento del completamento dello studio di lead-in sono eleggibili per l'arruolamento entro un anno dalla visita di fine trattamento del lead-in.
    2. Completare le valutazioni di screening e al Basale per confermare l'eleggibilità a partecipare se sono trascorsi più di 30 giorni dalla fine della visita dello studio nello Studio INS1009-201, nello Studio INS1009-202 o in qualsiasi altro studio di lead-in su TPIP per PAH.
    3. Essere in grado di fornire un consenso informato firmato.
    E.4Principal exclusion criteria
    1. Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PAH TPIP study, which, in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant.
    2. Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009-201, INS1009-202 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso®] or iloprost) and oral prostacyclin analogues (eg, TRE [Orenitram®]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.
    3. Pregnant or breastfeeding.
    4. Any medical or psychological condition, including relevant laboratory abnormalities, at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.
    1. Partecipanti che hanno sperimentato un'ipersensibilità o una reazione avversa al farmaco o che sono stati ritirati in anticipo/hanno interrotto un precedente studio su TPIP per PAH poiché ciò, secondo l'opinione dello Sperimentatore, indicherebbe che la continuazione del trattamento con TPIP può rappresentare un rischio irragionevole per il partecipante.
    2. Inizio della somministrazione parenterale di analoghi della prostaciclina (per es. TRE, epoprostenolo) dal completamento degli studi INS1009-201, INS1009-202 o di altri studi su TPIP. L'inizio della somministrazione di analoghi della prostaciclina per via inalatoria (per es. TRE [Tyvaso®] o iloprost) e per via orale (per es. TRE [Orenitram®]) o di agonisti del recettore (per es. selexipag) è consentito se interrotto
    24 ore prima dell'inizio della somministrazione del farmaco in studio.
    3. Gravidanza o allattamento.
    4. Eventuali condizioni mediche o psicologiche, comprese anomalie di laboratorio rilevanti allo Screening che, secondo l'opinione dello Sperimentatore, suggeriscono una malattia nuova e/o non sufficientemente compresa che può rappresentare un rischio irragionevole per il partecipante allo studio come conseguenza della sua partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of TEAEs
    Frequenza e gravità dei TEAE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    Durante lo studio.
    E.5.2Secondary end point(s)
    -Change in 6MWD (absolute and relative).
    -Change in the concentration of NT-proBNP in blood.
    - Change in the REVEAL Lite 2.0 score.
    -Annualized rate of clinical worsening events (as defined in the protocol)
    -Plasma concentration levels of TP and TRE.
    - Variazione (assoluta e relativa) nel 6MWT.
    - Variazione nella concentrazione di NTproBNP nel sangue
    - Variazione d nel punteggio REVEAL Lite 2.0.
    - Tasso annualizzato di eventi di peggioramento clinico (come definito nel protocollo)
    - Livelli di concentrazione plasmatica di TP e TRE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - From pre-OLE baseline to Month 6, Month 12, Month 18, and Month 24
    - From pre-OLE baseline* to Month 6, Month 12, Month 18, and Month 24
    - From pre-OLE baseline* to Month 6, Month 12, Month 18, and Month 24
    -Throughout the study
    -Throughout the study
    - Dal Basale pre-OLE al Mese 6, al Mese 12, al Mese 18 e al Mese 24.
    - Dal Basale pre-OLE al Mese 6, al Mese 12, al Mese 18 e al Mese 24.
    - Dal Basale pre-OLE al Mese 6, al Mese 12, al Mese 18 e al Mese 24.
    - Durante lo studio.
    - Durante lo studio.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 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
    Periodo di titolazione di 3 sett per partecipanti che provengono immediatamente da studio lead-in
    3-week blinded titration period for participants enrolling immediately from a lead in study.
    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 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 EEA35
    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
    Argentina
    Australia
    Brazil
    Japan
    Malaysia
    Mexico
    Peru
    Philippines
    United States
    Austria
    Spain
    Switzerland
    Germany
    Italy
    Belgium
    Denmark
    United Kingdom
    Serbia
    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
    The end of study is defined as the date of the last Follow-Up phone call or visit for the last participant in the study.
    La fine dello studio è definita come la data dell'ultima telefonata di follow-up o visita per l'ultimo partecipante allo studio.
    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 months6
    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 months6
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 99
    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)
    Following completion of the open label study, subjects will be discontinued from study medication and continue their care under their physician.
    Dopo il completamento dello studio, i soggetti saranno sospesi dal farmaco in studio e continueranno la loro cura sotto il loro medico.
    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 Decision2023-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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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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