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    Summary
    EudraCT Number:2016-003341-28
    Sponsor's Protocol Code Number:PARA_003
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-16
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-003341-28
    A.3Full title of the trial
    A phase 2, randomised, double-blind, placebo-controlled, crossover study to evaluate the effects of a topical pentosan polysulphate sodium (PPS) formulation in subjects with seasonal allergic rhinitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2, randomised, double-blind, placebo-controlled, crossover study to evaluate the effects of pentosan polysulphate sodium (PPS) administered as a nose spray in subjects with pollen allergy
    En fas 2, randomiserad, dubbel blind, placebokontrollerad och "crossover" studie för att utvärdera effekten av lokalt pentosan polyfosfat natrium (PPS) på försökspersoner med allergisk rinit (hösnuva)
    A.4.1Sponsor's protocol code numberPARA_003
    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 SponsorParadigm Biopharmaceuticals
    B.1.3.4CountryAustralia
    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 supportParadigm Biopharmaceuticals
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationParadigm Biopharmaceuticals
    B.5.2Functional name of contact pointOperations Manager
    B.5.3 Address:
    B.5.3.1Street AddressLevel 2, Flinders Lane
    B.5.3.2Town/ cityMelbourne
    B.5.3.3Post codeVictoria 3000
    B.5.3.4CountryAustralia
    B.5.4Telephone number+61 413 421 160
    B.5.6E-mailckaufman@paradigmbiopharma.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 nameRhinosul
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPENTOSAN POLYSULFATE SODIUM
    D.3.9.1CAS number 37319-17-8
    D.3.9.4EV Substance CodeSUB14801MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 placeboNasal spray
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Seasonal allergic rhinitis
    E.1.1.1Medical condition in easily understood language
    Allergy to pollen
    Pollenallergi
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10039776
    E.1.2Term Seasonal allergic rhinitis
    E.1.2System Organ Class 100000004870
    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 is to assess the effect of a topical PPS formulation on post-challenge nasal symptoms using an allergen challenge model in subjects with seasonal allergic rhinitis.
    E.2.2Secondary objectives of the trial
    • Assess the effect of a topical PPS formulation on morning and evening nasal symptoms in subjects with seasonal allergic rhinitis using the allergen challenge model

    • Assess the effect of a topical PPS formulation on peak nasal inspiratory flow (PNIF) in subjects with seasonal allergic rhinitis using the allergen challenge model

    • Assess the safety and tolerability of a topical PPS formulation in subjects with seasonal allergic rhinitis undergoing allergen challenge
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects have to meet all of the following criteria to be eligible to enter the study:
    1) Willingness and ability to provide written informed consent and adhere to study procedures

    2) Male or female, in good general health

    3) Age 18 to 65 years

    4) Seasonal allergic rhinitis for at least 2 years prior to screening

    5) Positive skin prick test for birch and/or grass pollen allergen at screening or in the previous 12 months (as documented in the subject’s medical records)

    6) Absence of symptoms outside the pollen season

    7) Need for treatment upon seasonal allergen exposure

    8) Positive response to allergen challenge during nasal titration (5 sneezes or a symptom score of 2 or more on a scale of 0 to 3 for either nasal secretion or nasal congestion)

    9) Ability to speak, read and otherwise understand Swedish

    10) Agreement to use adequate contraceptive measures:

    Female subjects who
    (i) have been post-menopausal for more than 1 year, (ii) have been sterilised or

    (iii) agree to use a highly effective method of contraception (i.e. a method with a failure rate of less than 1% [e.g. oral contraceptives, hormone implants, hormone injections, some intrauterine devices or vasectomised partner]) from screening until 28 days after the last dose of investigational medicinal product (IMP)

    Male subjects who
    (i) agree to use condoms from screening until 28 days after the last dose of IMP or

    (ii) have a partner who is using a highly effective method of contraception, as described above
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will not be permitted to enter the study:

    1) Any disease that would compromise subject safety or data validity, as judged by the Investigator

    2) Symptomatic perennial allergic rhinitis

    3) Asthma (except for completely-resolved childhood asthma, with no symptoms for >5 years)

    4) Clinically relevant structural nasal abnormalities, as judged by the Investigator

    5) Clinical signs and symptoms of active infection, including any acute or chronic respiratory tract infection in the 2 weeks prior to the first day of treatment period 1 (treatment period 1 may be deferred in such circumstances at the discretion of the Investigator)

    6) Use of inhaled or systemic corticosteroids in the 4 weeks prior to day 1 of treatment period 1

    7) Use of anti-histamines in the week prior to day 1 of treatment period 1

    8) Previous immunotherapy as a treatment intervention for allergic rhinitis, including monoclonal antibody therapy (lifetime history), as judged by the Investigator

    9) Use of any other prescription, non-prescription (over-the-counter) or complementary medicines within 14 days prior to day 1 of treatment period 1 (except occasional use of paracetamol [up to 2 g per day] or hormonal contraceptives) that would compromise subject safety or data validity, as judged by the Investigator

    10) Known hypersensitivity or allergy to PPS, chemically related products or any of the excipients

    11) History of alcohol or substance abuse, as judged by the Investigator

    12) Positive viral test result for hepatitis B or C or HIV 1 or 2

    13) APTT outside the normal range at screening

    14) Female subjects: current breast-feeding or intention to become pregnant within 28 days after the last IMP dose

    15) Participation in another clinical trial in the previous month or less than 5 half-lives since an IMP was last administered in another clinical trial, or plans to enter another clinical trial during enrolment in this clinical trial

    16) Being a family member of any employee of the Investigator and/or Sponsor with direct involvement in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is mean post-challenge TNSS over the last 3 days of allergen challenge (treatment days 12 to 14).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment day 12 to 14
    E.5.2Secondary end point(s)
    • Mean morning and evening TNSS over the last 3 days of allergen challenge (treatment days 12 to 14)

    • Mean scores for individual nasal symptoms (nasal secretion, nasal congestion, sneezing and nasal itching) over the last 3 days of allergen challenge

    • Mean PNIF over the last 3 days of allergen challenge
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment day 12 to 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 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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory:
    To analyse the effect of a topical PPS formulation on the immune response in subjects with seasonal allergic rhinitis who are exposed to allergen challenge.
    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 Yes
    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 years0
    E.8.9.1In the Member State concerned months5
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2016-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-22
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