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    Summary
    EudraCT Number:2017-003435-11
    Sponsor's Protocol Code Number:VL2397-201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-14
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2017-003435-11
    A.3Full title of the trial
    A Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Immunocompromised Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare an antifungal drug, called VL-2397, with commonly
    marketed drugs against Invasive Aspergillosis in adults who are immunocompromised
    A.4.1Sponsor's protocol code numberVL2397-201
    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 SponsorVical 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 supportVical Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVical Incorporated
    B.5.2Functional name of contact pointMammen P. Mammen, Jr.
    B.5.3 Address:
    B.5.3.1Street Address10390 Pacific Center Court
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18586461120
    B.5.5Fax number+18586461151
    B.5.6E-mailmammen.mammen@vical.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 nameVL-2397 for Injection
    D.3.2Product code VL-2397
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAn INN has not been proposed for VL-2397
    D.3.9.1CAS number 1186200-57-6
    D.3.9.2Current sponsor codeVL-2397
    D.3.9.3Other descriptive nameASP2397; AS2102397-00; SVS-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVORICONAZOLE
    D.3.9.1CAS number 137234-62-9
    D.3.9.4EV Substance CodeSUB00087MIG
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNISAVUCONAZOLE
    D.3.9.1CAS number 241479-67-4
    D.3.9.4EV Substance CodeSUB128138
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMPHOTERICINE B, LIPOSOME
    D.3.9.1CAS number 8000078-82-2
    D.3.9.4EV Substance CodeSUB12887MIG
    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
    Invasive Aspergillosis
    E.1.1.1Medical condition in easily understood language
    A life-threatening fungal infection caused by Aspergillus species in patients with suppressed immune systems; Invasive Aspergillosis primarily affects lungs, causing fever, cough, shortness of breath
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10051597
    E.1.2Term Cerebral aspergillosis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10006473
    E.1.2Term Bronchopulmonary aspergillosis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003490
    E.1.2Term Aspergillosis pharyngeal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022881
    E.1.2Term Invasive bronchopulmonary aspergillosis
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003488
    E.1.2Term Aspergillosis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that treatment with VL-2397 is non-inferior to standard
    treatment (voriconazole (with TDM), isavuconazole, or liposomal
    amphotericin) in the comparison of ACM at 4 weeks in immunocompromised adults with possible, probable, or proven IA.
    E.2.2Secondary objectives of the trial
    To demonstrate that treatment with VL-2397 for 28 days followed by
    voriconazole, isavuconazole, or liposomal amphotericin B is non-inferior
    to Standard Treatment in the comparison of ACM at 6 weeks in immunocompromised adults
    with possible, probable, or proven IA.
    To provide supportive information for the primary and key secondary
    endpoints and to provide further information on potential uses and
    benefits of VL-2397.
    To analyze the full (intensive) PK profile of VL-2397 in at least 10
    participants; to analyze sparse PK from all other participants.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion into the VL2397-201 study, participants must meet all of the following criteria:
    1. Male or female (non-pregnant) participants, ≥ age 18 years at the time of consent, and hospitalized at randomization; women of childbearing potential must have a negative serum pregnancy test during screening
    2. New diagnosis of possible, probable, or proven pulmonary (or sinopulmonary) IA as defined by the 2008 EORTC/MSG criteria with at least one of the following host factors:
     Acute leukemia (AML or ALL) or other hematological condition (chronic leukemia, myelodysplastic syndrome, multiple myeloma, or aplastic anemia) with severe neutropenia temporally related to the onset of IA
     Allogeneic HCT recipient
     Hematological condition (acute or chronic leukemia, myelodysplastic syndrome, multiple myeloma, or aplastic anemia), lymphoma, solid organ transplant or autologous HCT recipient receiving immunosuppressive therapy. Note: Immunosuppressive therapy is recent use of corticosteroids (at a mean minimum dose of 0.3 mg/kg/day of prednisone or equivalent for > 3 weeks) or other immunosuppressants such as calcineurin inhibitors, TNF-α blockers, T-cell-specific monoclonal antibodies, or nucleoside analogs.
    3. Able to provide informed consent and willing to comply with the study requirements
    E.4Principal exclusion criteria
    Potential participants will be excluded from the study if any of the following criteria are met:
    1. Respiratory failure on mechanical ventilation
    2. Refractory or relapsed leukemia unlikely to respond to reinduction chemotherapy (unless the participant is an allo-HCT recipient)
    3. Severe neutropenia (absolute neutrophil count < 500/μL ) for > 10 days that is unlikely to recover during the study
    4. Unlikely to survive 30 days after first dose of Study Drug due to graft failure, severe (grade 4) acute graft-versus-host disease (GvHD), refractory chronic GvHD, or other life-threatening condition
    5. IA (proven or suspected) involving sites other than lungs and sinuses, including central nervous system (CNS), skin, or liver, and/or disseminated disease
    6. Suspected or proven infection with Candida krusei
    7. Systemic infection with a bacterial or viral pathogen that is not under control or cannot be treated, or systemic infection with a fungal pathogen other than Aspergillus. Note: Uncomplicated bacteremia, uncomplicated urinary tract infection, and CMV viremia without end organ disease are allowed.
    8. Uncontrolled diabetes (given the inherent higher risk for mucormycosis), unless the diagnosis is proven or probable IA
    9. Recent episode of acute IA not responding to treatment, chronic aspergillosis, aspergilloma in pre-existing cavity, or allergic aspergillosis
    10. Receipt of > 4 cumulative days of systemic antifungal treatment for IA within 7 days prior to study entry. Note: Recent or prior use of a mold-active antifungal for prophylaxis, as determined by the Investigator, is allowed.
    11. Hepatic dysfunction, defined as any one of the following: total bilirubin ≥ 3 x the upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 x ULN, cirrhosis, or chronic hepatic failure
    12. Moderate to severe renal dysfunction defined as any one of the following: creatinine clearance < 50 mL/min at screening, currently on dialysis, or likely to require dialysis during administration of Study Drug
    13. Treatment with any investigational drug in a clinical trial within 14 days prior to the first dose of Study Drug
    14. Any known or suspected condition of the potential participant that could jeopardize participant adherence to study requirements or impede the accurate assessments of efficacy
    15. Males and females of childbearing potential who are unwilling to use highly effective contraceptive methods throughout the study
    16. Pregnant or breastfeeding females
    17. Alcohol intolerance or dependence (alcoholism)
    18. Epilepsy that may be exacerbated by alcohol intake
    E.5 End points
    E.5.1Primary end point(s)
    ACM at 4 weeks in the ITT population
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 4 weeks
    E.5.2Secondary end point(s)
    ACM at 6 weeks in the ITT Population.
    To provide supportive information for the primary and key secondary endpoints and to provide further information on potential uses and benefits of VL-2397
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 6 weeks
    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) 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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 EEA16
    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
    Belgium
    Canada
    France
    Germany
    Korea, Republic of
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 200
    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)
    All subjects who end their participation in the trial will continue to be monitored by their respective physicians, using standard medical care. No special procedures or extra medical care, that would not otherwise be used or provided in patients who have not participated in the trial, is needed after the trial.
    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 Decision2018-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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