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    Summary
    EudraCT Number:2013-002185-39
    Sponsor's Protocol Code Number:CR8020FLZ2002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-002185-39
    A.3Full title of the trial
    Randomised, Double-Blind, Placebo-Controlled, Phase IIa Study in Healthy Volunteers to Evaluate the Protective Efficacy and Safety of CR8020 in an Influenza Challenge Model
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of CR8020, a monoclonal antibody, against influenza
    A.4.1Sponsor's protocol code numberCR8020FLZ2002
    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 SponsorCrucell Holland B.V
    B.1.3.4CountrySweden
    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 supportCrucell Holland BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCrucell Vaccine Institute
    B.5.2Functional name of contact pointProgram Director
    B.5.3 Address:
    B.5.3.1Street AddressNewtonweg 1
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CP
    B.5.3.4CountryNetherlands
    B.5.6E-mailBduncan@its.jnj.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 CR8020/JNJ-54235051
    D.3.4Pharmaceutical form Powder 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 INNNA
    D.3.9.2Current sponsor codeCR8020
    D.3.9.3Other descriptive nameJNJ-54235051
    D.3.9.4EV Substance CodeSUB122459
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    D.3.11.13.1Other medicinal product type Monoclonal Antibody
    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
    E.1.1.1Medical condition in easily understood language
    Influenza
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    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 evaluate the reduction in AUC of virus load from the nasal mucosa in the CR8020 treatment group compared to placebo, post influenza virus challenge

    E.2.2Secondary objectives of the trial
    •To evaluate the reduction in the incidence of influenza infection in the CR8020 treated group compared to placebo
    •To evaluate the reduction in total AUC Influenza composite symptoms after challenge in the CR8020 group compared to the placebo group
    • To evaluate the pharmacokinetics of CR8020
    • To evaluate the safety of CR8020 compared with placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Male and female subjects ≥ 18 and ≤ 45 years of age
    2)In good health, with no major medical conditions from medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation
    3)A total body weight ≥50 kg and a BMI of >18. If the BMI is above 28 the subject may be included if the waist measurement is less than 94 cm (male), or less than 80 cm (female)
    4)(a)Male subjects must use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine until after the Day 96 (± 5 days) Follow-up Visit.
    (b)In addition, male subjects must not donate sperm following discharge from Quarantine until after the Day 96 (± 5 days) Follow-up Visit
    (c)Female subjects must be either:
    •Documented status as surgically sterile or post hysterectomy or-
    •If of childbearing potential, must have a negative serum and urine pregnancy test at SSS and Day -4/-3 and must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine and continue until the Day 96 (± 5 days) Follow-up Visit.
    Acceptable forms of effective contraception include:
    •Established use of oral, injected or implanted hormonal methods of contraception
    •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    •Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    •Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female subjects on the study, the vasectomised male partner should be the sole partner for that subject].
    •True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
    5)An informed consent document signed and dated by the subject and Investigator
    6)Sero-suitable for challenge virus

    E.4Principal exclusion criteria
    1) Subjects who have a significant history of tobacco use at any time (≥ total 10 pack year history, e.g. one pack a day for 10 years)
    2)(a) Females who are pregnant or have been pregnant within six months prior to the study, or who have been breastfeeding within three months prior to screening. Females who have a positive pregnancy test at any point in the study will be withdrawn immediately.
    (b) Females intending to become pregnant within three months of administration of CR8020 or placebo or males with female partners intending to become pregnant within three months of administration of CR8020 or placebo
    3) Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator
    4) Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities on spirometry
    5) History or evidence of autoimmune disease or known immunodeficiency of any cause
    6) Subjects with any history of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology (See No. 7 for asthma)
    7) Asthma (A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Patients with a single episode of wheezing after age 12 (lasting less than eight weeks) can be included at the Investigator's discretion)
    8) Positive human immunodeficiency virus (HIV), Hepatitis A (HAV), B (HBV), or C (HCV) test
    9) Any significant abnormality altering the anatomy of the nose or nasopharynx
    10) Any clinically significant history of epistaxis
    11) Any nasal or sinus surgery within six months of Viral Challenge
    12) Recurrent history of clinically significant autonomic dysfunction
    13) Any abnormal laboratory test or ECG which is deemed by the Investigator(s) to be clinically significant
    14) Confirmed positive test for drugs of abuse deemed by the Investigator to be clinically significant
    15) Venous access deemed inadequate for the phlebotomy and cannulation demands of the study
    16) Known allergy to any of the following:
    excipients in the Challenge Virus inoculum
    Any CR8020 excipients (sucrose, L-histidine L-histidine monohydrochloride, polysorbate 20)
    oseltamivir or other influenza treatments
    17) Health care workers (e.g. doctors, nurses, medical students and allied healthcare professionals) who work in units with severely immuno-compromised patients (e.g. bone marrow transplant units)
    18) Presence of household member or close contact(s) (for an additional two weeks after discharge from the isolation facility) who:
    has known immunodeficiency, is receiving immunosuppressant medication, is undergoing or soon to undergo cancer chemotherapy within 28 days of Viral Challenge, has been diagnosed with emphysema, COPD, or other severe lung disease and resides in a nursing home has received a bone marrow or solid organ transplant
    19) Evidence of vaccinations within the four weeks prior to Human Viral Challenge
    Intention to receive travel vaccination(s) before the Day 96 (± 5 days) Follow Up Visit
    20) Those employed or immediate relatives of those employed at RVL or the Sponsor
    21) Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood, during the three months prior to Viral Challenge or planned donation/receipt throughout the course of the study
    22) Use of nasal steroids within 28 days prior to Viral Challenge (Day 0)
    Use of any other medication or product (prescription or over-the-counter), for symptoms of hay fever, rhinitis, nasal congestion or respiratory tract infection within seven days of Viral Challenge (Day 0)
    23) Receipt of any investigational drug within three months prior to Viral Challenge
    Prior participation in a clinical trial with the same strain of respiratory virus
    Participation in any other Human Viral Challenge study with a respiratory virus within one year prior to the day of Viral Challenge
    24)Receipt of systemic glucocorticoids, antiviral drugs, or immunoglobulins (Igs) or any other cytotoxic or immunosuppressive drug within six months prior to dosing, or receipt or any systemic chemotherapeutic agent at any time
    25)Previous receipt of monoclonal antibodies or monoclonal antibody fragments at any time
    26)Presence of significant respiratory symptoms existing on the day of challenge or between admission to the unit and inoculation with the Challenge Virus
    History suggestive of respiratory infection within 14 days prior to admission to the Quarantine Unit
    27)Any other finding that, in the opinion of the Investigator or Sponsor, deems the subject unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    AUC of viral load. Measured from the nasal mucosa (by qPCR) post influenza virus challenge (Day 7)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to day 7
    E.5.2Secondary end point(s)
    1) Incidence of influenza infection will be determined as >/= 4 qPCR positive nasopharyngeal swabs
    2) AUC composite influenza symptoms will be ascertained from diary cards completed by each volunteer
    3) PK CR8020 will be determine by immunoassay
    4) afety will be assessed from physical examination, vital signs, diary cards and clinical laboratory safety assessments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) up to 7 days after challenge
    2) up to7 days after challenge
    3) Day -2 pre-infusion and end of infusion (2.25h), Day -1 (24 post-end of infusion), Day 0 pre-challenge (48h post-end of infusion ) and on Days 1 (72h post-EOI), 2 (96h post-EOI), Day 5, Day 28 (± 3 days) and Day 96(± 5 days)
    4) From signature of ICF until end of study (Day 96)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned 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: 22
    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 Yes
    F.3.2Patients No
    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 state22
    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)
    No plans for treatment or care are planned as the study involves
    healthy volunteers.
    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 Decision2013-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-22
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