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    Summary
    EudraCT Number:2017-001838-26
    Sponsor's Protocol Code Number:THEA-LT0455-PIV-09/16
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-001838-26
    A.3Full title of the trial
    Comparison of NAABAK® efficacy versus FLUCON® in the treatment of moderate manifestations of allergic conjunctivitis to birch pollen in subjects exposed to birch in ALYATEC’s environmental exposure chamber (EEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of NAABAK® efficacy versus FLUCON® in the treatment of moderate manifestations of allergic conjunctivitis to birch pollen in subjects exposed to birch in ALYATEC's EEC
    A.4.1Sponsor's protocol code numberTHEA-LT0455-PIV-09/16
    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 SponsorTHEA
    B.1.3.4CountryFrance
    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 supportTHEA LABORATORY
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALYATEC
    B.5.2Functional name of contact pointChief Operating Officer
    B.5.3 Address:
    B.5.3.1Street Address1 place de l'Hôpital
    B.5.3.2Town/ citySTRASBOURG
    B.5.3.3Post code67000
    B.5.3.4CountryFrance
    B.5.4Telephone number+330367680090
    B.5.5Fax number+330388119100
    B.5.6E-mailnathalie.domis@alyatec.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 Yes
    D.2.1.1.1Trade name NAABAK
    D.2.1.1.2Name of the Marketing Authorisation holderTHEA LABORATORY
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name FLUCON
    D.2.1.1.2Name of the Marketing Authorisation holderALCON LABORATORY
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects presenting moderate allergic conjunctivitis to birch pollen
    E.1.1.1Medical condition in easily understood language
    Subjects presenting moderate allergic conjunctivitis
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10010741
    E.1.2Term Conjunctivitis
    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 efficacy of NAABAK® compared to FLUCON®, assessed by the measure of the amount of major birch pollen allergen required to trigger a conjunctival response in subjects presenting moderate symptoms of allergic conjunctivitis caused by birch pollen.
    E.2.2Secondary objectives of the trial
    1. To evaluate the time required to obtain a positive Abelson score in both subjects groups during an allergen exposure in ALYATEC environmental chamber.
    2. To evaluate the onset of conjunctival symptoms during an allergen exposure in ALYATEC environmental chamber.
    3. To appreciate the correlation between the dose of allergen required to induce a positive conjunctival provocation unitary test and the dose required to induce a conjunctival response, during an exposure to birch pollen allergen in ALYATEC environmental chamber.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adults aged 18-65 years, with moderate manifestations of allergic conjunctivitis with or without allergic rhinitis.
    • The history of moderate conjunctivitis in the last 2 years according to EAACI recommendations.
    • Positive Prick tests (papule diameter greater than 6 mm compared to the negative control),
    • IgE specific to Bet v1 greater than 0.70 kUI / l
    • Individual conjunctival challenge test positive for birch pollen (Abelson score ≥ 5).
    E.4Principal exclusion criteria
    • Personal or family history of glaucoma
    • Eye Hypertension
    • Eye surgery within 6 months of inclusion in the study
    • Other forms of allergic conjunctivitis: Vernal and atopic keratoconjunctivitis, giant papillary conjunctivitis, perannual allergic conjunctivitis
    • Non-specific conjunctival hyperreactivity
    • Herpetic keratitis
    • Viral diseases of the cornea and conjunctiva
    • Tuberculous lesions and untreated bacterial infections of the eye;
    • Fungal diseases of ocular structures
    • Affection of the sclera or cornea
    • Dry eye syndrome
    • dysimmune diseases that may interfere with the study (dry syndrome in the context of inflammatory rheumatism)
    • Allergic pathology (rhinitis, conjunctivitis) not controlled
    • Uncontrolled asthma requiring a short-acting B2 mimetic more than twice a week or requiring that taken within the last 15 days.
    E.5 End points
    E.5.1Primary end point(s)
    • Allergen quantity needed to induce a positive conjunctival response (Abelson score ≥ 5).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Expo 1 (D1 + D2) and at Expo 2 (D1 + D2)
    E.5.2Secondary end point(s)
    1. Time to reach a positive conjunctival response (Abelson score ≥ 5) in both treatments groups
    2. Evaluation of the onset of conjunctival symptoms during birch allergens exposures (Abelson score by physician, TOSS and conjunctivitis VAS)
    3. Correlation between the the dose of allergen required to induce a positive conjunctival provocation unitary test and the dose required to induce a conjunctival response in the EEC
    4. Safety : VEMS measurements
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Abelson score, TOSS and conjunctivitis VAS : every 10 minutes during the first hour, then every 20 minutes for the next 3 hours
    - VEMS measurements : every 30 minutes during exposures
    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 No
    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
    Non-inferiority
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Investigator mask / blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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
    Last visit of the last subject undergoing the trial
    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 months6
    E.8.9.1In the Member State concerned days
    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: 24
    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 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 state24
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-31
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