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    Summary
    EudraCT Number:2017-003356-23
    Sponsor's Protocol Code Number:ALX0171-C204
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-01-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-003356-23
    A.3Full title of the trial
    A randomized, double-blind, multicenter study to evaluate the efficacy and safety of ALX-0171 versus placebo, in addition to standard of care, in adults who have undergone hematopoietic stem cell transplantation and present with a respiratory syncytial virus respiratory tract infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of ALX-0171 in adults hematopoietic stem cell transplant (HST) recipients who present with an respiratory syncytial virus (RSV) infection
    A.3.2Name or abbreviated title of the trial where available
    Safety and antiviral effect of ALX-0171 in adult HSCT recipients who present with RSV infection
    A.4.1Sponsor's protocol code numberALX0171-C204
    A.5.4Other Identifiers
    Name:INDNumber:136212
    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 SponsorAblynx NV
    B.1.3.4CountryBelgium
    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 supportAblynx NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAblynx NV
    B.5.2Functional name of contact pointClinical Trial Team
    B.5.3 Address:
    B.5.3.1Street AddressTechnologiepark
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number003292620000
    B.5.5Fax number003292620001
    B.5.6E-mailclinicaltrials@ablynx.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 nameALX-0171
    D.3.2Product code ALX-0171
    D.3.4Pharmaceutical form 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 INNnot assigned
    D.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeALX-0171
    D.3.9.3Other descriptive nameALX-0171
    D.3.9.4EV Substance CodeSUB117525
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 placeboNebulisation 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
    Respiratory Syncytial Virus Infection
    E.1.1.1Medical condition in easily understood language
    RSV infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    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
    The primary objective of the trial is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with RSV respiratory tract infection after HSCT
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial are: assess the clinical activity, PK, virology and immunogenecity of inhaled ALX-0171 in adults diagnosed with RSC respiratory tract infection after HSCT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is male or female, inpatient/outpatient, agend 18-75 years at screening
    2. Subject has received an HSCT using any conditioning regiment and for any underlying etiology (an autologous HSCT within 90 days of screening or an allogeneic HSCT within 180 days of screening or an allogeneic HSCT within 365 days of screening with ongoing chronic GVHD requiring systemic immunosuppresive therapy or subjects who have undergone transplantation with T-cell-depleted graft)
    3. Clinically diagnosed with RSV infection with new onset or acute worsening (in case of pre-existing symptoms due to underlying respiratory disease) of at least one of the following symptoms: rhinorrhea/nasal congestion, sore throat, cough or dyspnea
    4. Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization as judged by the investigator
    5. Documented RSV infection in the upper respiratory tract (ie mid-turbinate nasal swam, nasopharyngeal swab, nasopharyngeal aspirate, nasal wash), as determined by local testing. Samples collected within 5 days of screening will be acceptable. If not yet available the assessments should be performed at the time of screening.
    6. Subject has: a) diagnosis of RSV LRT disease OR b) diagnosis of RSV URT disease with high risk of progression to LRTI
    7. Female subjects of childbearing potential (ie fertile, following menarche and until becoming post-menopausal unless permanently sterile) and fertile male subjects must agree to use highly effective contraceptive methods prior to study entry, for the duration of the study participation and for 3 months after the last dose of the study drug.
    8. Female subjects of childbearing potential (exclusing postmenopausal women, sterilized, ovariectomized and hysterectomized women) must have a negative pregnancy test assessed locally at screening
    9. Subject is capable to comprehend the informed consent document and provides a signed and dated Informed Consent Form
    10. Subject must be willing and able (according to the investigator) to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    E.4Principal exclusion criteria
    1. Subject has clinically significant bacteremia or fungemia within 7 days of screening for which adequate treatment has not been completed at screening as determined by the investigator
    2. Subject has clinically significant bacterial, fungal or viral pneumonia (other than the current RSV episode) within 15 days of screening that has not been adequately treated, as determined by the investigator
    3. Subject is known to be HIV positive
    4. Subject presents evidence of shock requiring ICU monitoring and/or vasopressor treatment
    5. Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support (CPAP, BiPAP, HFOT). Standard oxygen supplementation up to 6l/minute is permitted provided it can be interrupted for the duration of the study drug administration
    6. Subject has been/is being treated with any of the following
    - any investigational antiviral medication or investigational biological within 5 half lives of screening
    - any investigational inhaled treatment within 5 half lives of screening
    - any monoclonal anti-RSV antibodies within 4 months or 5 half lives of screening (whichever is longer)
    - any investigational vaccine after HSCT
    - Aerosolized ribavirin within 3 days of screening or needing to initiate or continue this treatment
    7. Subject is pregnant or breastfeeding
    8. Subject has history of drug or alcohol abuse within 5 years of screening
    9. Subject has concurrent life-threatening disease with life expectancy of less than 1 month
    10. Subject has significant underlying lung disease that confounds the assessment of the RSV episode or any condition that, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of any study endpoints
    11. Subject was previously enrolled in a clinical study of ALX-0171 (including the current study ALX0171-C204)
    12. Subject has a known hypersensitivity to the study drug or any excipient of the study drug
    E.5 End points
    E.5.1Primary end point(s)
    Time-weighted average change from baseline to day 7 in log RSV nasal viral load (as measured by quantative reverse transcriptase polymerase chain reaction)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline
    Day 7
    E.5.2Secondary end point(s)
    - The safety profile of ALX-0171 (as assessed by AEs, physical examination, clinical laboratory assessments, vital signs and oxygen saturation)
    - Nasal RSV load parameters over time, including time to undetectable shelding
    - Clinical stabilization, defined as respiratory rate <25/min and stable oxygen saturation >92% on room air for at least 12 hours, by Day 7 and up to EOS visit for subjects with LRTI at baseline
    - Percentage of subjects needing any supplemental oxygen therapy and percentage of subjects needing >2 l/minute oxygen supplementation through Day 7 and up to EOS visit
    - Number of day without oxygen or without oxygen supplementation at levels <= 2L/minute through Day7 and up to EOS visit
    - Progression to LRTI disease in subjects presenting with URTI at baseline by Day 7 and up to EOS visit. Progression to LRTI will be conducted by the investigator based on standard of care clinical, radiological and laboratory assessments
    - The PK parameters of ALX-0171 (serum concentrations of ALX-0171, area under the curve, Cmax, Tmax)
    - ADA serum concentrations over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 42
    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) 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 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 trial3
    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.8.5The 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
    Australia
    Belgium
    Brazil
    France
    Germany
    Italy
    Spain
    Turkey
    United States
    E.8.7Trial has a data monitoring committee No
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 35
    F.4.2.2In the whole clinical trial 75
    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 - patients will receive standard of care after study end
    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 Decision2018-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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