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    Summary
    EudraCT Number:2018-003205-25
    Sponsor's Protocol Code Number:BT-L-CsA-302-DLT
    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:2019-01-18
    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 number2018-003205-25
    A.3Full title of the trial
    A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
    Ensayo clínico de fase III, prospectivo, multicéntrico, aleatorizado y controlado para demostrar la eficacia y la seguridad de Ciclosporina A Liposómica (L-CsA) solución para inhalación administrada mediante el dispositivo en investigación eFlow® de PARI más el tratamiento de referencia frente al tratamiento de referencia solo en el tratamiento del síndrome de bronquiolitis obliterante en pacientes tras un trasplante pulmonar doble
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.
    Estudio de investigación clínica de la efectividad y seguridad de Ciclosporina A Liposómica (L-CsA) en pacientes con bronquiolitis obliterante en pacientes tras un trasplante pulmonar doble.
    A.3.2Name or abbreviated title of the trial where available
    BOSTON-2
    A.4.1Sponsor's protocol code numberBT-L-CsA-302-DLT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03656926
    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 SponsorBREATH Therapeutics 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 supportBREATH Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBREATH Therapeutics Inc.
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address633 Menlo Avenue #230
    B.5.3.2Town/ cityMenlo Park
    B.5.3.3Post codeCA 94025
    B.5.3.4CountryUnited States
    B.5.6E-mailcontact@breath-therapeutics.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/3/04/210
    D.3 Description of the IMP
    D.3.1Product nameLiposomal Cyclosporine A
    D.3.2Product code L-CsA
    D.3.4Pharmaceutical form Powder and solvent for 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 INNCiclosporin (Ciclosporinium)
    D.3.9.1CAS number 59865-13-3
    D.3.9.2Current sponsor codeL-CsA
    D.3.9.3Other descriptive nameCICLOSPORIN A
    D.3.9.4EV Substance CodeSUB129839
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
    Bronquiolitis obliterante en pacientes tras un trasplante pulmonar doble
    E.1.1.1Medical condition in easily understood language
    Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
    Bronquiolitis obliterante en pacientes tras un trasplante pulmonar doble
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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 and safety of add-on aerosolized L-CsA to Standard of Care therapy as compared to SoC therapy alone in the treatment of BOS in double lung transplant recipients.
    Evaluar la eficacia y la seguridad de L-CsA más el tratamiento de referencia en el tratamiento del SBO en
    receptores de trasplante pulmonar doble (TPD).
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients of ≥18 years.
    2. Patients with diagnosis of BOS Grade 0-p with screening FEV1 between 85-81% of personal best FEV1 value post transplant plus risk factors as defined below, OR BOS Grade 1 with screening FEV1 between 80-66% of personal best FEV1 value post-transplant. Patients with a diagnosis of BOS Grade 0-p must have ≥ 2 of these risk factors for BOS:
    - Primary graft dysfunction (PGD)
    - Acute cellular rejection
    - Lymphocytic bronchiolitis
    - Humoral rejection (e.g. de novo anti-human leukocyte antigen antibodies)
    - Gastro-oesophageal reflux and microaspiration
    - Infection (Viral, Bacterial, Fungal)
    - Persistent neutrophil influx and sequestration (bronchoalveolar lavage neutrophilia)
    - Autoimmunity (collagen V sensitization).
    3. Patients with an FEV1/FVC ratio of < 0.8.
    4. Patients in whom the diagnosis of BOS has been confirmed by the elimination of other possible causes of obstructive lung disease.
    5. Patients with a diagnosis of BOS 0-p or BOS 1 made at least 1 year after transplant surgery and within 6 months prior to the Screening Visit.
    6. Patients receiving a tacrolimus-based basic immunosuppression regimen in combination with MMF (or equivalent) and corticosteroids. This basic immunosuppression regimen must be stable (without changes to doses) for at least 4-weeks prior to Randomization.
    7. Patients must consent to retrieve prespecified data from the historic medical record (e.g., information related to the transplant surgery; spirometry data; medication use).
    8. Patients must be receiving prophylaxis against Cytomegalovirus (CMV) and Pneumocystis pneumonia.
    9. Patients capable of understanding the purposes and risks of the clinical trial, who have given written informed consent and agree to comply with the clinical trial requirements/visit schedules, and who are capable of aerosol inhalation.
    10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and must agree to use one of the methods of contraception listed in Appendix II for their duration of clinical trial participation.
    11. Patients have no concomitant diagnoses that are considered fatal within one year (12 months).
    1. Pacientes adultos ≥18 años.
    2. Pacientes con diagnóstico de SBO de grado 0-p con un VEF1 en la selección entre el 85-81 % del mejor valor personal del VEF1 tras el trasplante más factores de riesgo como se definen a continuación, O SBO de grado 1 con un VEF1 en la selección entre el 80-66 % del mejor valor personal del VEF1 tras el trasplante.
    Los pacientes con diagnóstico de SBO de grado 0-p deben tener ≥2 de estos factores de riesgo del SBO:
    - Disfunción del trasplante primario (DTP)
    - Rechazo celular agudo
    - Bronquiolitis linfocítica
    - Rechazo humoral (p. ej., anticuerpos anti-antígeno leucocitario humano de novo)
    - Reflujo gastroesofágico y microaspiración
    - Infección (vírica, bacteriana, fúngica)
    - Influjo y secuestro persistente de neutrófilos (neutrofilia en el lavado broncoalveolar)
    - Autoinmunidad (sensibilización al colágeno V)
    3. Pacientes con una relación VEF1/CVF <0,8.
    4. Pacientes en quienes el diagnóstico de SBO se ha confirmado descartando otras posibles causas de enfermedad pulmonar obstructiva.
    5. Pacientes con un diagnóstico de SBO de grado 0-p o SBO de grado 1 desde al menos 1 año después de la cirugía de trasplante y en los 6 meses anteriores a la visita de selección.
    6. Pacientes que reciben un esquema de inmunosupresión básico basado en tacrolimus en combinación con MMF (o equivalente) y corticoesteroides. Este esquema de inmunosupresión básico debe ser estable (sin cambios en las dosis) desde al menos 4 semanas antes de la aleatorización.
    7. Los pacientes deben dar su consentimiento para la recuperación de los datos preespecificados de las historias clínicas (p. ej., información relacionada con la cirugía de trasplante; datos de espirometría; uso de medicamentos).
    8. Los pacientes deben estar recibiendo tratamiento profiláctico contra el citomegalovirus (CMV) y la neumonía por Pneumocystis.
    9. Pacientes capaces de entender los propósitos y los riesgos del ensayo clínico, que han otorgado el consentimiento informado por escrito y aceptan cumplir los requisitos/calendario de visitas del ensayo clínico y que son capaces de inhalar el aerosol.
    10. Las mujeres en edad fértil deben tener una prueba de embarazo en suero negativa en los 7 días anteriores a la aleatorización y deben aceptar utilizar uno de los métodos anticonceptivos enumerados en el Apéndice II durante toda la participación en el ensayo clínico.
    11. Los pacientes no deben tener al mismo tiempo otros diagnósticos que les puedan ocasionar la muerte en el plazo de 1 año (12 meses).
    E.4Principal exclusion criteria
    1. Patients with confirmed other causes for loss of lung function, such as infection, acute rejection, restrictive allograft syndrome (RAS), etc.
    2. Cystic Fibrosis patients with multi-drug resistant infections not responding to available anti-microbial therapies.
    3. Patients with donor-specific antibody (DSA) positivity at the Screening Visit.
    4. Active bacterial, viral, or fungal infection not successfully resolved at least 4 weeks prior to the Screening Visit.
    5. Mechanical ventilation within 12 weeks prior to Randomization.
    6. Patient has baseline resting oxygen saturation of < 89% on room air or use of supplemental oxygen.
    7. History or presence of bronchial strictures or airway stents or airways requiring balloon dilatations to maintain patency.
    8. Known hypersensitivity to L-CsA or to cyclosporine A.
    9. Patients with chronic renal failure defined as serum creatinine > 2.5 mg/dL or requiring chronic dialysis.
    10. Patients with liver disease and serum bilirubin > 3-fold upper normal value or transaminases > 2.5 upper normal value.
    11. Patients with a history of malignancy, including post-transplant lymphoproliferative disorder, with the exception of treated, localized basal and squamous cell carcinomas.
    12. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy over the course of the clinical trial.
    13. Women who are currently breastfeeding.
    14. Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to the Screening Visit. This is defined as any treatment that is implemented under an Investigational New Drug (IND) or compassionate use.
    15. Patients who have received extracorporeal photophoresis (ECP) for treatment of BOS within 2 months prior to Randomization.
    16. Patients who are currently participating in an interventional clinical trial.
    17. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures.
    18. Any co-existing medical condition that in the Investigator’s judgment will substantially increase the risk associated with the patient’s participation in the clinical trial.
    1. Pacientes con pérdida de la función pulmonar confirmada por otras causas, tales como infección, rechazo agudo, síndrome restrictivo del aloinjerto (SRA), etc.
    2. Pacientes con fibrosis quística y con infecciones resistentes a múltiples medicamentos que no responde a los tratamientos antibacterianos disponibles.
    3. Pacientes con positividad para anticuerpos específicos del donante en la visita de selección.
    4. Infección bacteriana, vírica o fúngica activa no resuelta satisfactoriamente al menos 4 semanas antes de la visita de selección.
    5. Ventilación mecánica en las 12 semanas anteriores a la aleatorización.
    6. Pacientes con saturación de oxígeno en reposo basal <89 % con aire ambiente o uso de oxígeno suplementario.
    7. Antecedentes o presencia de estenosis bronquial o stents en las vías respiratorias o vías respiratorias que requieren dilatación con balón para mantener la permeabilidad.
    8. Hipersensibilidad conocida a L-CsA o a la ciclosporina A.
    9. Pacientes con insuficiencia renal crónica, definida como creatinina sérica >2,5 mg/dl, o que requieren diálisis crónica.
    10. Pacientes con enfermedad hepática y bilirrubina sérica >3 veces el límite superior de la normalidad o transaminasas >2,5 veces el límite superior de la normalidad.
    11. Pacientes con antecedentes de neoplasias malignas, incluido el trastorno linfoproliferativo postrasplante, con la excepción de los carcinomas de células escamosas y basales localizados y tratados.
    12. Mujeres embarazadas o mujeres que no quieran utilizar un anticonceptivo adecuado para evitar el embarazo durante el ensayo clínico.
    13. Mujeres que estén actualmente en periodo de lactancia materna.
    14. Pacientes que hayan recibido un medicamento en investigación como parte de un ensayo clínico en las 4 semanas anteriores a la visita de selección. Esto se define como cualquier tratamiento que se implemente con la denominación de producto en investigación (PEI) o de uso compasivo.
    15. Pacientes que hayan recibido fotoaféresis extracorpórea (FEC) para el tratamiento del SBO en los 2 meses anteriores a la aleatorización.
    16. Pacientes que estén participando actualmente en otro ensayo clínico intervencional.
    17. Pacientes con trastornos psiquiátricos o alteraciones mentales que les impidan entender el proceso para otorgar el consentimiento informado y/o completar los procedimientos necesarios.
    18. Cualquier afección médica coexistente que, en opinión del investigador, aumente sustancialmente el riesgo asociado a la participación del paciente en el ensayo clínico.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in FEV1 (mL) from baseline.
    Cambio medio en VEF1 (ml) desde el valor basal hasta la semana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    E.5.2Secondary end point(s)
    • Mean change in FEV1/FVC from baseline;
    • Time to Progression of BOS, defined as the earliest of the following:
    - Absolute decrease from baseline in FEV1 ≥10% or ≥200 mL and absolute decrease in FEV1/FVC of > 5%, OR
    - Change in BOS Grade, OR
    - Re-transplantation, OR
    - Death from respiratory failure
    This endpoint will be assessed in a combined analysis with a similar Phase III clinical trial, BT – L-CsA – 302 – DLT (BOSTON-2) which will be conducted in the same investigational centers in patients who have undergone double-lung transplantations.
    • Cambio medio en VEF1/CVF desde el valor basal hasta la semana 48.
    • Tiempo hasta la progresión del SBO definida como lo que suceda primero de los siguientes:
    - Disminución absoluta desde el valor basal en VEF1 ≥10 % o ≥200 ml y disminución absoluta en VEF1/CVF >5 %, O
    - Cambio en el grado del SBO, O
    - Retransplante, O
    - Muerte por fallo respiratorio
    Este criterio de valoración se evaluará en un análisis combinado con un ensayo clínico de fase III similar, BT – L-CsA – 302 – DLT (BOSTON-12) que se realizará en los mismos centros de investigación en pacientes que se han
    sometido a un trasplante pulmonar doble
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Week 48
    • Time to Progression
    • Semana 48
    • Tiempo de progresión
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Personal que realiza espirometría,estadísticos y adm.datos serán ciegos a la asignación de tto
    Staff conducting spirometry, statisticians and data managers will be blinded to treatment assignment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento de referencia
    Standard of Care
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Austria
    Belgium
    France
    Germany
    Israel
    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
    Última visita del último paciente (UVUP)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days2
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 110
    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 who complete BOSTON-2 will be eligible to participate in a follow-on study, BT – L-CsA – 303 – FU (BOSTON-3).
    Pacientes que completan BOSTON-2 pueden ser seleccionados para participar en el seguimiento del estudio, BT – L-CsA – 303 – FU (BOSTON-3).
    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 Decision2019-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-22
    P. End of Trial
    P.End of Trial StatusOngoing
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