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    Summary
    EudraCT Number:2021-004554-32
    Sponsor's Protocol Code Number:PC_ASP_006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-004554-32
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis
    Estudio aleatorizado, con enmascaramiento doble, comparativo con un placebo, para evaluar la seguridad y la eficacia del PC945 nebulizado cuando se añade a una terapia antifúngica sistémica para el tratamiento de la aspergilosis pulmonar invasiva resistente al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of PC945 in combination with other antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis
    Seguridad y eficacia del PC945 cuando se añade otra terapia antifúngica para el tratamiento de la aspergilosis pulmonar invasiva resistente al tratamiento
    A.4.1Sponsor's protocol code numberPC_ASP_006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05238116
    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 SponsorPulmocide Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportPulmocide Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPulmocide Ltd
    B.5.2Functional name of contact pointPulmocide Admin
    B.5.3 Address:
    B.5.3.1Street Address44 Southampton Buildings
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2A 1AP
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailadmin@pulmocide.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 namePC945
    D.3.4Pharmaceutical form Nebuliser liquid
    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 INNOpelconazole
    D.3.9.1CAS number 1931946-73-4
    D.3.9.2Current sponsor codePC945
    D.3.9.4EV Substance CodeSUB221421
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.0
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNebuliser liquid
    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
    Refractory invasive pulmonary aspergillosis (IPA)
    Aspergilosis pulmonar invasiva (API) resistente al tratamiento
    E.1.1.1Medical condition in easily understood language
    Fungal infection of the airway
    Infección fúngica de la via respiratoria
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10059259
    E.1.2Term Pulmonary aspergillosis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
    Evaluar la eficacia del PC945 nebulizado en combinación con una terapia antifúngica sistémica para el tratamiento de la API resistente al tratamiento
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA.
    Evaluar la seguridad y tolerabilidad del PC945 nebulizado en combinación con una terapia antifúngica sistémica para el tratamiento de la API resistente al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant has proven or probable IPA according to the 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients
    2. Participant’s IPA has an unfavorable response to adequate antifungal therapy
    1. El paciente presenta una API probada o probable de acuerdo con las definiciones de consenso de la EORTC / el MSGERC de 2019, el diagnóstico probado o probable de API puede confirmarse utilizando las declaraciones de consenso de la ISHLT de 2010 en relación con las definiciones de infecciones en personas que reciban trasplantes cardiotorácicos
    2. La API del paciente presenta una respuesta desfavorable a un tratamiento antifúngico adecuado
    E.4Principal exclusion criteria
    1. Participant with a known or suspected concomitant medical condition or post-surgery complication that, in the opinion of the Investigator, may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy or may be an unacceptable additional risk to the Participant should he/she participate in the study
    2. Participant who has previously received PC945
    3. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations
    4. Participant who is participating, or who is due to participate at any time during the study, in a therapeutic or diagnostic clinical trial
    1. Paciente con sospecha o confirmación de enfermedad concomitante o complicación posoperatoria que, en opinión del investigador, pueda poner en peligro el cumplimiento de los requisitos del protocolo o impedir la medición precisa de la eficacia, o que pueda suponer un riesgo adicional inaceptable para el paciente en caso de que participe en el studio
    2. Paciente que haya recibido PC945 anteriormente
    3. Paciente con antecedentes de alergia, hipersensibilidad o cualquier reacción grave previa a cualquier componente de las formulaciones de PC945 o del placebo
    4. Paciente que esté participando o esté previsto que vaya recibir un medicamento en investigación en cualquier momento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Number of Participants with Complete or Partial Overall Response
    Número de pacientes con una respuesta global completa o parcial
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 12 weeks
    hasta 12 semanas
    E.5.2Secondary end point(s)
    Time to Complete or Partial Overall Clinical Response
    Tiempo transcurrido hasta una respuesta clínica global completa o parcial
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 12 weeks
    hasta 12 semanas
    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 Yes
    E.6.7Pharmacodynamic No
    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 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 No
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Argentina
    Brazil
    Canada
    Chile
    Colombia
    India
    Israel
    Korea, Republic of
    Taiwan
    United States
    Austria
    France
    Spain
    Germany
    Greece
    Italy
    Belgium
    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
    última visita del último sujeto
    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 months7
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days15
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 123
    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.
    Ninguno
    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 Decision2022-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
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