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    Summary
    EudraCT Number:2015-001314-10
    Sponsor's Protocol Code Number:EFC14280
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-13
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-001314-10
    A.3Full title of the trial
    A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients with Bilateral Nasal Polyposis on a Background Therapy with Intranasal Corticosteroids
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Controlled Clinical Study of Dupilumab in Patients with Nasal Polyps
    A.3.2Name or abbreviated title of the trial where available
    SINUS-52
    A.4.1Sponsor's protocol code numberEFC14280
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1170-7180
    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 SponsorSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    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 supportSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Belgium
    B.5.2Functional name of contact pointBrigitte De Witte
    B.5.3 Address:
    B.5.3.1Street AddressAirport Plaza - Montreal Building, L. Da Vinncilaan
    B.5.3.2Town/ cityDiegem
    B.5.3.3Post code1831
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 (0)2 710 54 11
    B.5.5Fax number+32 (0)2 710 56 99
    B.5.6E-mailContact-us@sanofi.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 namedupilumab
    D.3.2Product code SAR231893
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bilateral nasal polyposis
    E.1.1.1Medical condition in easily understood language
    Bilateral nasal polyposis
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028756
    E.1.2Term Nasal polyps
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 dupilumab compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyposis score (NPS) in patients with bilateral nasal polyposis (NP). In addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses will be also a coprimary objective.
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).
    -To evaluate the efficacy of dupilumab in improving sense of smell.
    -To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (Primary objective for Japan).
    -To evaluate ability of dupilumab in reducing proportion of patients requiring treatment with systemic corticosteroids or NP surgery.
    -To evaluate the effect of dupilumab on patient reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22).
    -To evaluate efficacy with various regimen.
    -To evaluate the effect of dupilumab in the subgroups of patients with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated respiratory disease NERD]).
    -To evaluate the safety of dupilumab in patients with bilateral NP.
    -To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatmentemergent anti-drug antibodies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or have a medical contraindication/intolerance to SCS, and/or had prior surgery for NP at the screening visit, have:

    -An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).

    -Ongoing symptoms (for at least 8 weeks before V1) of nasal congestion/ blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at time of randomization (V2), and another symptom such as loss of smell, rhinorrhea (anterior/posterior).

    -Signed written informed consent.
    E.4Principal exclusion criteria
    - Patients <18 years of age.

    - Patient who has been previously treated in dupilumab studies.

    - Patient who has taken:

    -Biologic therapy/ systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 2 months before V1 or 5 half-lives, whichever is longer.

    -Any experimental monoclonal antibody (mAB) within 5 half-lives or within 6 months before V1 if the half-life is unknown.

    -Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to V1.

    -Patients who are receiving leukotriene antagonists/modifiers at V1 unless they are on a
    continuous treatment for at least 30 days prior to V1.

    - Initiation of allergen immunotherapy within 3 months prior to V1 or a plan to begin therapy or change its dose during the run-in period or the randomized treatment period.

    - Patients who have undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months before V1.

    - Patients who have had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.

    - Patients with conditions/concomitant diseases making them non evaluable at V1 or for the primary
    efficacy endpoint such as:

    -Antrochoanal polyps,

    -Nasal septal deviation that would occlude at least one nostril,

    -Acute sinusitis, nasal infection or upper respiratory infection,

    -Ongoing rhinitis medicamentosa,

    -Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener’s granulomatosis),Young’s syndrome, Kartagener’s syndrome or other dyskinetic ciliary
    syndromes, concomitant cystic fibrosis,

    -Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis.

    - Patients with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc.).

    - Patients with forced expiratory volume (FEV1) 50% or less (of predicted normal).

    - Patients receiving concomitant treatment prohibited in the study.

    - Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.

    - History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.

    - Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit.

    - Active chronic or acute infection requiring systemic treatment within 2 weeks before the Baseline visit.

    - Known or suspected history of immunosuppression.

    - Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

    - Women unwilling to use adequate birth control, if of reproductive potential and sexually active.

    Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.



    E.5 End points
    E.5.1Primary end point(s)
    1- Change from baseline in nasal congestion/obstruction (NC) symptom severity score based on the patient daily morning assessment

    2- Change from baseline in nasal polyposis score (NPS) as assessed by nasal endoscopy

    3- Change from baseline in sinus opacifications as assessed by computed tomography (CT) scans using Lund Mackay Score (For Japan only)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2-3 : From baseline to Week 24
    E.5.2Secondary end point(s)
    1- Change from baseline in total symptoms score (TSS)

    2- Change from baseline in University of Pennsylvania Smell
    Identification Test

    3- Change from baseline in severity of decreased/ loss of smell as assessed by the patient

    4- Change from baseline in sinus opacifications as assessed by CT scans using Lund Mackay Score (This endpoint will not be assessed as a secondary endpoint for Japan as it is already a co-primary endpoint).

    5- Change from baseline in in sinonasal outcome test-22 (SNOT-22)

    6- Proportion of patients during study treatment receiving systemic corticosteroid for NP and/or planned to under surgery for nasal polyps

    7- Change from baseline in NC for every 2 weeks (q2w) (Arm A) versus placebo (Arm C)

    8- Change from baseline in NPS for q2w (Arm A) versus placebo (Arm C)

    9- Change from baseline in NC for q2w/q4w (Arm B) versus placebo (Arm C)

    10- Change from baseline in NPS for q2w/q4w (Arm B) versus placebo (Arm C)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2-3-4-5 : From baseline to Week 24

    6: 52 weeks

    7-8-9-10 : From baseline to Week 52
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    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
    Argentina
    Australia
    Belgium
    Canada
    Chile
    Israel
    Japan
    Mexico
    Portugal
    Russian Federation
    Spain
    Sweden
    Turkey
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial 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: 655
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 720
    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 Decision2016-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-16
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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