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    Summary
    EudraCT Number:2007-006003-21
    Sponsor's Protocol Code Number:WF10-07-002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-28
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-006003-21
    A.3Full title of the trial
    A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY OF
    THE EFFICACY AND SAFETY OF WF10 IN SUBJECTS SUFFERING FROM
    PERSISTENT ALLERGIC RHINITIS
    A.4.1Sponsor's protocol code numberWF10-07-002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNuvo Research GmbH
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameWF10
    D.3.2Product code OXO-K993
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeOXO-K993
    D.3.9.3Other descriptive nameStabilized Chlorite Solution
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number63 (chlorite)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeanorganic immunomodulating product
    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 placeboConcentrate for solution 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
    Persistent Allergic Rhinitis.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy and safety of WF10 infusions in the treatment of
    subjects with persistent allergic rhinitis.

    The primary efficacy variable will be the reflective TNSS. The primary efficacy analysis will be the change from baseline to final of the TNSS. Baseline TNSS is calculated as the mean of the morning and evening TNSS assessments for the 3 days prior to Visit T1 plus the morning pre-dose TNSS on Day 1 (total of 7 assessments). The final TNSS is defined as the mean of the morning and evening TNSS assessments for the 3 days prior to Visit F3 plus the morning TNSS on Visit F3 (total of 7 assessments)
    E.2.2Secondary objectives of the trial
    Secondary efficacy analyses will include comparison of the change from Visit T1 to Visit F3 of the visit day mean TNSS score (i.e., night before and morning of visit day), morning TNSS score, evening TNSS score, MiniRQLQ score, POHA score, and rhinometric and spirometric parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.) History of persistent allergic rhinitis for at least 2 years prior to enrolment. Concurrent history of asthma is permitted.
    2.) Positive allergen skin test to the relevant allergen(s), performed within the previous 2 years prior to enrolment.
    3.) Mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS) (see section
    10.2.3.1.1 (a) for definition of baseline TNSS).
    4.) Screening laboratory values within normal range, except those related to the primary disease, including eosinophil count, and elevated glucose is allowed.
    5.) Age between 18 and 65 years, inclusive.
    6.) The subject must be able to read and understand German well enough to answer the questions in the TNSS and Mini Rhinoconjunctivitis Quality of Life Questionnaire
    (MiniRQLQ), without any translation or explanation.
    7.)If female, the subject:
    a) Cannot become pregnant because she is surgically sterile (hysterectomy or tubal
    ligation), or is postmenopausal for at least 6 months prior to the screening visit. OR
    b) Is not pregnant, with a negative pregnancy test at screening (confirmed at the baseline visit), and uses an acceptable method of contraception with a low failure rate (PEARL Index) (i.e. less than 1% per year) when used consistently and correct (including oral contraceptives, hormone implant, intrauterine device, male sexual partner(s) surgically sterile, abstinence).
    8.) Except for persistent allergic rhinitis, the subject is in reasonably good health, as
    determined by the discretion of the study investigator (based on the physical examination and electrocardiogram [ECG] results).
    9.) The subject has signed an informed consent form.
    E.4Principal exclusion criteria
    1.) Non-allergic rhinitis, rhinitis medicamentosa, idiopathic rhinitis or sinusitis.
    2.) History of nasal surgery in the 6 months prior to enrolment.
    3.) An upper respiratory or sinus infection within the 2 weeks prior to enrolment.
    4.) Presence of a severely deviated septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction.
    5.) Use of intramuscular glucocorticosteroids in the 12 weeks prior to enrolment; use of oral, intravenous or inhaled glucocorticosteroids in the 4 weeks prior to enrolment; use of topical (nasal or ocular) glucocorticosteroids in the 2 weeks prior to enrolment.
    6.) Use of anti-IgE antibodies (e.g. omalizumab) in the 12 weeks prior to enrolment.
    7.) Use of anti-leukotrienes (e.g. montelukast) in the 4 weeks prior to enrolment.
    8.) Unwillingness to discontinue prohibited medications and avoid their use during the study.
    9.) Severe haematopoetic, cardiovascular, hepatic, renal, neurological or psychiatric disease.
    10.) Glucose-6-phosphate dehydrogenase deficiency (activity < 60% = < WHO class 4)
    11.) A female subject who is lactating.
    12.) Planned travel outside of the study area during the first 22 days of the study.
    13.) Any infirmity, disability or geographical location that would limit compliance with the protocol.
    14.) A subject who has previously been randomized into this study, received at least one dose of study treatment and been withdrawn from this trial will not be allowed to re-enter.
    15.) Use of another investigational drug within the 30 days prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    The conclusion of efficacy for the study intervention will be based on the primary efficacy analysis in the PP population data set. The primary efficacy analysis will be the comparison between treatment groups in the change from baseline (Visit T1) to Visit F3 of the TNSS.
    Baseline TNSS is calculated as the mean of the morning and evening TNSS assessments for the 3 days prior to Visit T1 plus the morning pre-dose TNSS on Day 1 (total of 7 assessments). The final TNSS is calculated as the mean of the morning and evening TNSS assessments for the 3 days prior to Visit F3 plus the morning TNSS at Visit F3 (total of 7 assessments).
    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 No
    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.8.3 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 Information not present in EudraCT
    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
    Last visit of last patient undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 state50
    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 Decision2010-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-23
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