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    Summary
    EudraCT Number:2014-002841-23
    Sponsor's Protocol Code Number:ALX0171-C104
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-08
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-002841-23
    A.3Full title of the trial
    A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171, Administered Via Inhalation, in Addition to Standard of Care
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase I/II Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171.
    A.4.1Sponsor's protocol code numberALX0171-C104
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/246/2014
    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 pointclinicaltrials@ablynx.com
    B.5.3 Address:
    B.5.3.1Street AddressTechnologiepark 21
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32(0)9 262 0000
    B.5.5Fax number+32(0)9 262 0035
    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 Nanobody
    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 yet
    D.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeALX-0171
    D.3.9.3Other descriptive nameALX-0171 Nanobody
    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 placeboNebuliser 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 Lower Respiratory Tract 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 18.0
    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
    To investigate the safety and tolerability of multiple doses of ALX-0171
    E.2.2Secondary objectives of the trial
    To evaluate the clinical effect of ALX-0171.

    To explore the pharmacodynamics of ALX-0171

    To explore the systemic pharmacokinetics of ALX-0171

    To explore the immunogenicity of ALX-0171
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is a male or female infant or toddler aged 5 months to < 24 months for the open-label lead-in, Part A, or 3 months to < 24 months for the double-blind part of the study, Part B. Upon implementation of a positive DMC recommendation, subjects may be aged 28 days to < 24 months in Part B. For the expansion cohort, Part C, the subject's age must be 28 days to < 5 months.
    2. Subject weighs at least 3,5 kg.
    3. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (bronchiolitis or broncho-pneumonia), i.e., showing typical clinical signs and symptoms such as tachypnoea, wheezing, cough, crackles, use of accessory muscles, and/or nasal flaring.
    4. Subject has appearance of symptoms that are likely related to RSV infection within ≤ 7 days at the time of screening, based on the Investigator's judgement.
    5. Subject has a positive RSV diagnostic test .
    6. Subject is expected to have to stay in the hospital for at least 24 hours (according to the Investigator’s judgement at screening).
    7. Subject has normal psychomotor development (according to the Investigator’s judgement at screening).
    8. Subject’s gestational age was > 37 weeks.
    9. Parent(s)/legal guardian(s) are able and willing to provide written informed consent.
    10. The subject and parent(s)/legal guardian(s) are able and willing to comply with the study protocol.
    E.4Principal exclusion criteria
    1. Subject has history of wheezing (i.e., >3 previous episodes of wheezing), as reported by the parent(s)/legal guardian(s), or according to the Investigator’s judgement at screening.
    2. Subject is known to have significant comorbidities, including genetic disorders (e.g., trisomy 21, cystic fibrosis), cardiopulmonary diseases (e.g., haemodynamically significant congenital heart disease, or bronchopulmonary dysplasia), any hereditary or acquired metabolic (bone) diseases, haematological or other malignancy, or is known to be human immunodeficiency virus (HIV) positive.
    3. Subject is known to be immunocompromised.
    4. Subject has any presence of active severe atopic dermatitis requiring daily use of topical anti-inflamatory (corticosteroïd or equivalent).
    5. Subject has any physician-confirmed food allergy.
    6. Subject is suspected of having a clinically relevant infection other than RSV.
    7. Subject received mechanical ventilation or long-term respiratory support in the past 4 weeks prior to screening.
    8. Subject has significant oral and/or maxillofacial malformations.
    9. Subject is critically ill and/or is expected to require invasive mechanical ventilation or noninvasive respiratory support (e.g., continuous or bilevel positive airway pressure, or high flow humidified nasal oxygen) within 24 hours (according to the Investigator’s judgement at screening), with the exception of O2 supplementation via nasal cannula, simple face mask, or headbox.
    10. Subject has received 1 or more doses of palivizumab at any time prior to screening, or has received treatment with any antiviral therapy for RSV (e.g., ribavirin or i.v. immunoglobulin) within 1 month prior to screening.Subjects planned to receive palivizumab treatment or other RSV prophylaxis should not be included in the study.
    11. Subject is being treated with corticosteroids and requires continued corticosteroïd therapy.
    12. Subject is being treated with antibiotics and needs continued antibiotic therapy. Note that subjects receiving antibiotics at screening will not be excluded if the antibiotics can be safely stopped according to the Investigator’s judgement. The initiation of antibiotic therapy during the study is allowed.
    13. Subject is currently participating in any investigational study, or has previously participated in study ALX0171-C104.
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Treatment emergent AEs, clinical laboratory test results (clinical chemistry and haematology), physical examination results including lung auscultation, and heart rate and SPO2 levels.
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 0 to day 14
    E.5.2Secondary end point(s)
    1) Clinical activity: feeding, respiratory rate, wheezing, crackles/crepitations, coughing, respiratory muscle retractions, general appearance
    2) Exploratory pharmacokinetics: ALX-0171 in serum
    3) Exploratory pharmacodynamics: viral load (nasal swaps), exploratory biomarkers in serum
    4) Exploratory immunogenicity: ADA in serum
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 0 to day 14
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    phase I/IIa
    E.7.2Therapeutic exploratory (Phase II) No
    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 Yes
    E.8.1.7.1Other trial design description
    First part of the study is open-label lead-in part; second part is double-blind placebo-controlled
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Bulgaria
    Estonia
    Hungary
    Israel
    Latvia
    Malaysia
    New Zealand
    Philippines
    Poland
    Slovakia
    Spain
    Thailand
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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 Yes
    F.1.1Number of subjects for this age range: 53
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 53
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    subjects will be infants and toddlers (aged 28 days -24 months)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 53
    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)
    After the end of the study, each subject will be treated according to standard clinical practice.
    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 ScotCRN Coordinating Center
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
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