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    Summary
    EudraCT Number:2015-004546-26
    Sponsor's Protocol Code Number:VIS410-202
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-16
    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 ConcernedLatvia - SAM
    A.2EudraCT number2015-004546-26
    A.3Full title of the trial
    A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of VIS410 in Subjects with Uncomplicated Influenza A Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to see if there are differences in flu symptoms when people receive a single infusion of VIS410, the study medicine, compared with those who receive placebo and to find out if VIS410 is safe and well tolerated
    A.4.1Sponsor's protocol code numberVIS410-202
    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 SponsorVisterra, 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 supportVisterra, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVisterra, Inc.
    B.5.2Functional name of contact pointEllie Hershberger, PharmD
    B.5.3 Address:
    B.5.3.1Street AddressOne Kendall Square, Suite B3301
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number1617498 1070
    B.5.5Fax number1617498 1073
    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 VIS410
    D.3.4Pharmaceutical form 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 INNVIS410
    D.3.9.3Other descriptive nameVIS410
    D.3.9.4EV Substance CodeSUB175945
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Influenza A infection
    E.1.1.1Medical condition in easily understood language
    Influenza (flu) 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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the safety and tolerability of a single intravenous (IV) infusion of 2 dose levels of VIS410 in patients with uncomplicated influenza infection
    E.2.2Secondary objectives of the trial
    •Evaluate the efficacy of 2 dose levels of VIS410 compared with placebo on the time to alleviation of clinical symptoms of acute uncomplicated influenza
    •Evaluate the effect of 2 dose levels of VIS410 on severity of influenza infection
    •Assess the pharmacokinetics of 2 dose levels of VIS410 in serum
    •Assess the effects of 2 dose levels of VIS410 on viral shedding
    •Assess the immunogenicity of 2 dose levels of VIS410
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the following criteria are eligible to participate in this study:
    1. Male and female subjects aged ≥18 years and < 65 years
    2. Women should fulfill one of the following criteria:
    a. Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone >40 mIU/mL as documented in their medical history.
    b. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation.
    c. Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post-infusion, per Section 7.1.2.
    3. Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method (see Section 7.1.2) when having heterosexual intercourse, from screening until 60 days post-infusion.
    4. Test positive for influenza A by Rapid Antigen Test performed with a commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions
    5. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of moderate to severe intensity, or presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of moderate to severe intensity
    6. Onset of symptoms (time when the oral temperature was first measured as either decreased [oral temperature of < 95°F or < 35°C] or elevated [oral temperature of ≥100.4°F or ≥38°C], OR the time when the subject experienced at least one respiratory symptom or at least one constitutional symptom) no more than 72 hours before the start of infusion
    7. Subject is able and willing to comply with study procedures, as per protocol
    8. Subject is able and willing to give voluntary written informed consent
    E.4Principal exclusion criteria
    Exclusion Criteria:
    Subjects meeting any of the following criteria are excluded from participation in this study:
    1. Use of NSAIDs or antihistamines within 6 hours of study drug dosing with the exception of those used as part of the pretreatment regimen.
    2. History of intolerance or allergic response to monoclonal antibodies and/or pretreatment medications diphenhydramine, ibuprofen and acetylsalicylic acid)
    3. History of receiving monoclonal antibody products within 3 months prior to enrollment in this study or planned administration during the study period
    4. Subjects in whom nasopharyngeal swabbing is not possible
    5. Subject weight less than (<) 45 kg
    6. Subjects with clinical history that would lead to increased risk of influenza complications including but not limited to clinically significant cardiac disease, moderate to severe asthma, or other moderate to severe chronic obstructive pulmonary disease, metabolic syndrome including moderate to severe diabetes, active tuberculosis, neuromuscular disorders, seizure disorders or cognitive dysfunction.
    7. History of chronic GI disease, including bleeding, ulceration, Irritable Bowel Syndrome, systemic mastocytosis or chronic diarrhea
    8. Women who are pregnant, breast-feeding, or considering becoming pregnant.
    9. Patients with hypoxemia requiring oxygen support.
    10. Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the Investigator's opinion, indicates that such finding(s) could represent complications of influenza
    11. Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy including systemic steroids.
    12. Presence of known Acquired Immune Deficiency Syndrome-defining illness, chronic hepatitis B or hepatitis C.
    13. Receipt of any dose of antiviral therapy such as, but not limited to, rimantadine, amantadine, peramivir, zanamivir, laninamivir or oseltamivir in the 7 days prior to screening
    14. Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer
    15. Presence of any pre-existing illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study
    16. Subjects unable to comply with study protocol procedures and study visit schedules for whatever reason
    17. Subjects unable to take oral predose medication
    18. Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator
    19. Subjects on chronic medications where the dose has not been stable for at least 3 months
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    • The proportion of subjects with adverse events (AEs) and serious adverse events (SAEs) following administration of VIS410
    • The proportion of subjects with treatment-emergent AEs (TEAEs) including hypersensitivity reaction, anaphylactic reaction, and AEs of special interest (AESIs) following dosing
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoints will be evaluated throughout the study, as
    assesments are done. End points defined by adverse events can be
    reached at any time.
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    • The incidence, severity, and duration of signs and symptoms of influenza-like illness as assessed by the Influenza Patient Reported Outcomes questionnaire after a single IV dose of VIS410
    • Percentage of participants requiring hospitalization for influenza-related complications
    • Duration of hospitalization for influenza-related complications
    • Percentage of participants with complications of influenza
    • Percentage of participants with influenza A relapse/reinfection
    • VIS410 pharmacokinetic (PK) parameters (Cmax, tmax, AUC0-∞, AUC0-last, t1/2, Vd, CL) in serum
    • The difference between VIS410 and placebo treatment groups in viral AUC from nasopharyngeal swabs
    • The difference between VIS410 and placebo treatment groups in peak viral load and time to resolution of viral load from nasopharyngeal swabs
    • Titer of anti-VIS410 antibody-positive samples
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated throughout the study, as
    assesments are done. End points defined by adverse events can be
    reached at any time.
    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 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 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.8.4.1Number 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 EEA40
    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
    Bulgaria
    Estonia
    Latvia
    Lithuania
    Serbia
    South Africa
    Ukraine
    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 years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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) 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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 150
    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
    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 Decision2017-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-27
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