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    Summary
    EudraCT Number:2022-003810-35
    Sponsor's Protocol Code Number:BMX-04-001
    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:2023-01-18
    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 number2022-003810-35
    A.3Full title of the trial
    A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects with Chronic Pseudomonas aeruginosa (PsA) Pulmonary Infection
    Estudio de fase 1b/2a multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar el tratamiento con bacteriófagos nebulizados en pacientes ambulatorios con fibrosis quística (FQ) en adultos con infección pulmonar crónica por Pseudomonas aeruginosa (PsA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas aeruginosa Pulmonary Infection
    Tratamiento con bacteriófagos nebulizados en pacientes con fibrosis quística e infección pulmonar crónica por Pseudomonas aeruginosa
    A.4.1Sponsor's protocol code numberBMX-04-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05010577
    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 SponsorBiomX Ltd.
    B.1.3.4CountryIsrael
    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 supportBiomX Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiomX Ltd
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address22 Einstein Str., Floor 5
    B.5.3.2Town/ cityNess Ziona
    B.5.3.3Post code7414003
    B.5.3.4CountryIsrael
    B.5.6E-mailinfo@biomx.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.3.2Product code BX004-A
    D.3.4Pharmaceutical form 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 INNnot applicable
    D.3.9.3Other descriptive nameIHMA-2121771-1
    D.3.9.4EV Substance CodeSUB302000
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100000000 to 10000000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot applicable
    D.3.9.3Other descriptive nameIHMA-2121771-2
    D.3.9.4EV Substance CodeSUB302001
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100000000 to 10000000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot applicable
    D.3.9.3Other descriptive nameIHMA-2121908-1
    D.3.9.4EV Substance CodeSUB302002
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100000000 to 10000000000
    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.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 placeboInhalation 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
    Chronic Pseudomonas Aeruginosa Infection
    Fibrosis quística
    Infección crónica por Pseudomonas aeruginosa
    E.1.1.1Medical condition in easily understood language
    Chronic lung infection with Pseudomonas bacteria in adults with cystic fibrosis
    Infección pulmonar crónica por bacterias Pseudomonas en adultos con fibrosis quística
    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 10011763
    E.1.2Term Cystic fibrosis lung
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10082869
    E.1.2Term Chronic Pseudomonas aeruginosa infection
    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 evaluate the safety and tolerability of nebulized BX004-A in CF subjects with chronic PsA pulmonary infection.
    Evaluar la seguridad y la tolerabilidad de BX004-A nebulizado en sujetos con FQ con infección pulmonar crónica por PsA
    E.2.2Secondary objectives of the trial
    not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
    2. Age ≥ 18 years
    3. FEV1 ≥ 40% predicted
    4. Clinically stable lung disease
    5. Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.
    1. Pacientes con fibrosis quística e infección pulmonar crónica por Pseudomonas aeruginosa que reciben medicamentos estándar para la FQ
    2. Edad ≥ 18 años
    3. FEV1 ≥ 40% previsto
    4. Enfermedad pulmonar clínicamente estable
    5. Estar dispuesto y ser capaz de proporcionar muestras de esputo adecuadas , utilizando cualquier método (expectoradas espontáneamente, inducido, en el hogar o en la clínica) en las visitas de estudio designadas.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to bacteriophages or excipients in the formulation.
    2. Receipt of prior bacteriophage therapy within the 6 months prior to Screening
    3. Recovery of Burkholderia species from respiratory tract within 1 year prior to screening
    4. Currently receiving treatment for allergic bronchopulmonary aspergillosis
    5. Currently receiving treatment for active infection with non-tuberculous mycobacteria
    6. History of severe neutropenia
    7. History of lung transplant
    8. History of solid organ transplant
    9. Acquired or primary immunodeficiency syndrome
    10. Initiation or change in CF modulator therapy less than 3 months prior to screening
    11. Pregnant or breastfeeding female
    1. Hipersensibilidad conocida a bacteriófagos o a los excipientes de la formulación.
    2. Recepción de terapia con bacteriófago previa en los 6 meses anteriores a la selección
    3. Recuperación de cualquier especie de Burkholderia de las vías respiratorias en el plazo de 1 año antes de la selección
    4. Estar recibiendo en la actualidad tratamiento para la aspergilosis broncopulmonar alérgica
    5. Estar recibiendo en la actualidad tratamiento para la infección activa con micobacterias no tuberculosas
    6. Antecedentes de neutropenia grave
    7. Antecedentes de trasplante de pulmón
    8. Antecedentes de trasplante de órgano sólido
    9. Síndrome de inmunodeficiencia adquirida o primaria
    10. Inicio o cambio en el tratamiento modulador de la FQ menos de 3 meses antes de la selección
    11. Mujeres embarazadas o en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability, as assessed by vital sign measurements, pulmonary examination, laboratory tests, spirometry and adverse events
    Seguridad y tolerabilidad, evaluadas mediante mediciones de signos vitales, examen pulmonar, pruebas de laboratorio, espirometría y eventos adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be assessed at every clinic visit: D1, D2, D3, D4, D8, D15 (also D35 phone call and 6 month phone call)
    La seguridad se evaluará en cada visita a la clínica: D1, D2, D3, D4, D8, D15 (también llamada telefónica D35 y llamada telefónica de 6 meses)
    E.5.2Secondary end point(s)
    not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    No aplica
    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 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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Israel
    United States
    Netherlands
    Spain
    Czechia
    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
    6-month post last dose phone call
    Llamada telefónica 6 meses después de la última dosis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months20
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 32
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Cystic Fibrosis Society/European Clinical Trials Network
    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 Decision2023-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-29
    P. End of Trial
    P.End of Trial StatusOngoing
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