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    Summary
    EudraCT Number:2012-005060-10
    Sponsor's Protocol Code Number:NVG09B113
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-03
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2012-005060-10
    A.3Full title of the trial
    A MULTICENTER, RANDOMIZED, DOUBLE-MASKED, 3 PARALLEL ARMS, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF NOVA22007 1MG/ML (CICLOSPORIN/CYCLOSPORINE) EYE DROPS, EMULSION ADMINISTERED IN PAEDIATRIC PATIENTS WITH ACTIVE SEVERE VERNAL KERATOCONJUNCTIVITIS WITH SEVERE KERATITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to study the safety and efficacy of NOVA22007 1mg/ml (Ciclosporin) eye drops in children over 4 with active severe vernal keratoconjunctivitis
    A.3.2Name or abbreviated title of the trial where available
    NVG09B113
    A.4.1Sponsor's protocol code numberNVG09B113
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/238/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovagali Pharma S.A.S.
    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 supportNovagali Pharma S.A.S.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiltern
    B.5.2Functional name of contact pointSharon Rouse
    B.5.3 Address:
    B.5.3.1Street Address171 Bath Road
    B.5.3.2Town/ citySlough
    B.5.3.3Post codeSL1 4AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number27766048967
    B.5.5Fax number441753511116
    B.5.6E-mailsharon.rouse@chiltern.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/360
    D.3 Description of the IMP
    D.3.1Product nameCiclosporin
    D.3.2Product code NOVA22007
    D.3.4Pharmaceutical form Eye drops, emulsion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiclosporin
    D.3.9.1CAS number 59865-13-3
    D.3.9.2Current sponsor code081400
    D.3.9.3Other descriptive nameCiclosporin (A), Cyclosporine, Cyclosporin A.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboEye drops, emulsion
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vernal Keratoconjunctivitis (VKC)
    E.1.1.1Medical condition in easily understood language
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10057383
    E.1.2Term Allergic keratoconjunctivitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the efficacy of two different dosing regimens of NOVA22007 versus placebo (vehicle of the formulation) on both the evolution of severe keratitis and the need for rescue medication.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    i)To assess the safety and tolerability including ocular tolerance of 2 dosing regimens of NOVA22007 versus placebo.
    ii)To assess the efficacy of 2 dosing regimens of NOVA22007 versus placebo on other signs and symptoms of VKC not covered in the primary objective.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Documented informed consent form signed by the subject or legal guardian and assent of the child, as appropriate, in accordance with local regulation and legal requirements. Assent will be required (as applicable) for children per local regulation and for those who, in the investigator’s judgment, are able to comprehend.
    2.Male or female patients from 4 to less than18 years of age.
    3.Female of childbearing potential must have a negative pregnancy test plus a medically acceptable, highly effective method of birth control (such as hormonal implants, injectable or oral contraceptives together with condoms, some intrauterine devices, sexual abstinence or vasectomized partner) throughout the conduct of the study and up to 2 weeks after the study end.
    4.History of at least one recurrence of VKC in the past year prior to enrolment.
    5.Patients not receiving any treatment for an established and active VKC; or patients already receiving treatment for their VKC provided treatment is stopped according to the wash-out period specified in the exclusion criteria.
    6.Active severe VKC consistent with grade 3 or 4 of Bonini scale (Bonini 2007) with severe keratitis (grade 4 or 5 on the modified Oxford scale).
    7.Mean score of 4 subjective symptoms (photophobia, tearing, itching and mucous discharge) ≥ 60 mm using a 100 mm Visual Analogue Scale (where “0” means no symptom and “100” means the worst that have been ever experienced).
    8.Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    9.Patient enrollment must occur early during the site VKC season in order to allow the 4 month treatment period during the site VKC season.
    E.4Principal exclusion criteria
    Ocular Conditions/Diseases:
    1.Any relevant ocular anomaly other than VKC interfering with the ocular surface including trauma, post radiation keratitis, severe blepharitis, rosacea, corneal ulcer etc.
    2.Abnormal lid anatomy, abnormalities of the nasolacrimal drainage system or blinking function in either eye.
    3.Active herpes keratitis or history of ocular herpes.
    4.History of ocular varicella-zoster or vaccinia virus infection.
    5.Active ocular infection (viral, bacterial, fungal, protozoal).
    6.Any ocular diseases other than VKC requiring topical ocular treatment during the course of the study.
    7.Contact lenses wear during the study.

    Ocular Treatments
    7.Topical and/or systemic use of corticosteroids within one week prior to enrolment.
    8.Topical ciclosporin (e.g. Restasis®), tacrolimus or sirolimus within 90 days prior to enrolment.
    9.Scraping of the vernal plaque within one month prior to the baseline visit.
    10.Ocular surgery within 6 months prior to the Baseline visit (excluding surgical treatment of the vernal plaque).

    Systemic Conditions/Diseases or Treatments
    11.Disease not stabilized within 30 days before the Baseline Visit (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease, current systemic infections) or judged by the investigator to be incompatible with the study.
    12.Presence or history of severe systemic allergy.
    13.Any intake of systemic immunosuppressant drugs within 90 days before the Baseline Visit.
    14.Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc).
    15.History of malignancy in the last 5 years.
    16.Pregnancy or lactation at the baseline Visit.

    Compliance/Administrative
    17.History of drug addiction or alcohol abuse.
    18.Presence or history of any systemic or ocular disorder, condition or disease that could possibly interfere with the conduct of the required study procedures or the interpretation of study results.
    19.Patient not covered by a health insurance if required by the national legislation.
    20.Participation in a clinical trial with an investigational substance within the past 30 days.
    21.Participation in another clinical study at the same time as the present study.
    E.5 End points
    E.5.1Primary end point(s)
    Composite efficacy score at 4 months, defined as the mean of the 4 efficacy scores taken at each monthly visit.

    Efficacy will be assessed every month during the 4 month treatment period and compared with baseline using a composite criterion based on:
    -Keratitis assessed by the modified Oxford scale
    -Need for rescue medication
    -Occurrence of corneal ulceration
    Efficacy score will be calculated as followed:
    Patient’s score at month X= CFS (baseline) – CFS (Month X)
    + penalty (ies)
    Penalty for rescue medication: -1 (per course, with a maximum of 2 courses between 2 scheduled visits)
    Penalty for corneal ulceration: -1 (per occurrence)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly for 4 months
    Μηνιαία για 4 μήνες
    E.5.2Secondary end point(s)
    Efficacy criteria
    •Use of rescue medication: the total number of topical corticosteroid courses will be assessed at each visit during the 4 month efficacy evaluation treatment period.
    •Keratitis assessed by the modified Oxford grading scale at each visit during the 4 month efficacy evaluation treatment period.
    •The 4 main symptoms (photophobia, tearing, itching and mucous discharge) assessed using a 100 mm VAS, individually and globally (average of the 4 measures) at each visit during the 4 month efficacy evaluation treatment period.
    •Responder: Patient 1) with a CFS score at Month 4 equal or smaller than 50% of the baseline CFS, 2) who did not withdrew from the trial for a reason possibly due to treatment, 3) free from occurrence of ulceration and use of rescue medication in the last three months of treatment
    •Objective signs: hyperaemia, conjunctival discharge, papillae and limbal infiltrates at each visit during the 4 month efficacy evaluation treatment period.
    •QUICK questionnaire assessed at baseline and months 1 to 4.
    •Investigator global assessment of the efficacy at each visit except at baseline.
    •Artificial tear use during the 4 month efficacy evaluation treatment period

    Safety/Tolerability criteria
    •Local ocular tolerance
    •Best corrected visual acuity
    •Incidence and severity of adverse events
    •CsA blood levels and creatinine levels, alanine aminotransferase (ALST) and aspartate aminotransferase (ASLT) at baseline, month 2, month 4, and month 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monthly for 4 months.

    The CsA blood levels and creatinine levels, alanine aminotransferase (AST) and aspartate aminotransferase (ALT) at will be done at baseline, month 2, month 4, and month 12.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Croatia
    France
    Germany
    Greece
    Hungary
    India
    Israel
    Italy
    Portugal
    Spain
    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
    Last patient last visit
    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 months26
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial months38
    E.8.9.2In all countries concerned by the trial days10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 168
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 110
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 58
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and adolescents who are unable to give their consent personally will participate in the study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 107
    F.4.2.2In the whole clinical trial 168
    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)
    Patients will return to standard of care treatment
    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 Decision2014-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-01
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