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    Summary
    EudraCT Number:2017-000186-76
    Sponsor's Protocol Code Number:MK-4117-200
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-01-23
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2017-000186-76
    A.3Full title of the trial
    A Phase III, Multi-Center, Randomized, Parallel-Group, Placebo-Controlled and Double- Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects with Perennial
    Allergic Rhinitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III clinical trial of MK-4117 in Japanese subjects with perennial allergic rhinitis, which means symptoms are present throughout the year.
    A.3.2Name or abbreviated title of the trial where available
    A Phase III clinical trial of MK-4117 in Japanese subjects with perennial allergic rhinitis
    A.4.1Sponsor's protocol code numberMK-4117-200
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01918033
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointDavid Muccino
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive - P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1732-594-5940
    B.5.6E-maildavid.muccino@merck.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 Aerius Azomyr Neoclarityn
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code MK-4117
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESLORATADINE
    D.3.9.2Current sponsor codeMK-4117
    D.3.9.3Other descriptive nameDESLORATADINE
    D.3.9.4EV Substance CodeSUB01596MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perennial allergic rhinitis
    E.1.1.1Medical condition in easily understood language
    Perennial allergic rhinitis (which means allergic symptoms are present throughout the year).
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10034382
    E.1.2Term Perennial allergic rhinitis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) To evaluate the efficacy of MK-4117 by comparing change from baseline in total nasal symptom score (sneezing, rhinorrhea, nasal congestion, and nasal itching) assessed by (sub-) investigator at Week 2 for MK-4117 10 mg group with placebo group.
    2) To evaluate the efficacy of MK-4117 by comparing change from baseline in total nasal symptom score (sneezing, rhinorrhea, nasal congestion, and nasal itching) assessed by (sub-) investigator at Week 2 for MK-4117 5 mg group with placebo group.
    3) To evaluate the safety and tolerability of MK-4117 10 mg and 5 mg administrated once daily for 2 weeks.
    E.2.2Secondary objectives of the trial
    1. For MK-4117 10 mg and 5 mg groups with placebo group, to compare change from baseline in:
    a) total nasal symptom score assessed by (sub-) investigator at Day 3 and Week 1.
    b) each nasal symptom score (sneezing, rhinorrhea, nasal congestion, and nasal itching) assessed by (sub-) investigator at Day 3, Week 1 and Week 2.
    c) each nasal finding score (swelling of inferior nasal concha mucosa, coloring of inferior nasal concha mucosa and nasal discharge production), eye (itching) symptom score and score of interference with daily activities assessed by (sub-) investigator at Day 3, Week 1 and Week 2.
    d) each nasal and eye (itching) symptom score reported in Subjects Allergy Diary at Day 3, Week 1 and Week 2.
    2) To compare percentage of subjects with moderate to remarkable improvement in 5 ratings of global improvement rate assessed by (sub-) investigator at Day 3, Week 1 and Week 2 for MK-4117 10 mg and 5 mg groups with placebo group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit 1/Screening
    •Perennial allergic rhinitis subject (Subject expected to meet the inclusion criteria 7 at Visit 2, based on nasal symptoms).
    •Subject either male or female who is 12 years and older when informed consent is given.
    •Out-patient
    •Subject who can make entries in the Subjects Allergy Diary or has a legal representative who can make entries.
    •Subject is a male, or a female that is unlikely to conceive as indicated by a response of yes to any one or more of the following questions: (1) Subject undergone a surgically sterilized female (hysterectomy, ligation of both fallopian tubes, or oophorectomy of both sides) (2) Subject reached natural menopause (defined as ≥12 months of spontaneous amenorrhea in woman ≥46 years of age) (3) Subject of reproductive potential and agrees to (a) remain abstinent or (b) use (or have her partner use) 2 acceptable method of birth control within the projected duration of the study (from giving written informed consent) and for 14 days after the last dose of study medication.
    •Subject who could understand the study objective and procedure, and has the ability to give informed assent/consent (informed assent and informed consent must also be obtained from a minor subject and legal representative, respectively, in the case of minors) before the study by subject’s own voluntary.

    At Visit 2/Week 0/ Randomization
    •Investigator assessed that subject’s symptoms which meet both 2 criteria below during 7 days just before Visit 2. (1) Subject having symptoms of PAR of moderate to severe degree, according to the classification of severity in the “Nasal Allergy Treatment Guideline - perennial rhinitis and pollinosis - 2013 (the revised 7th edition)” in Japan [2] (partial revision) (2) Subject having symptoms of PAR as a total score of at least 4 for nasal symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching).
    •Subjects confirmed to be perennial allergic background for mite and/or house dust antigen based on the allergic tests as indicated in the protocol.
    •Subjects whose drug incompliance during the screening period (up to 10 days) is less than 2 days.
    E.4Principal exclusion criteria
    At Visit 1/Screening
    •Subject with lower respiratory tract infection and subject who has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) judged by the investigator to require treatment.
    •Subject with coexisting infections or systemic mycosis for which there are no effective antibiotics.
    •Subject who has asthma complication under treatment.
    •Subject who has nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed.
    •Subject with complication of vasomotor rhinitis or eosinophilic rhinitis.
    •Subject with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
    •Subject with a history of hypersensitivity to antihistamines or ingredients of study drug.
    •Subject who cannot conduct the wash-off the drugs shown in the protocol from the Visit 1, or cannot avoid the use of these drugs during the study period.
    •Subject who had the following treatment within 7 days or 21 days before Visit 1. 1) Within 7 days before Visit 1: a. Corticosteroids (oral, nasal drops [including nasal inhaler], injectable, suppository) b.Immunological drugs 2) Within 21 days before Visit 1. a.Corticosteroids (depot drugs [injectable])
    •Subject who cannot avoid the use of prohibited drugs or therapiesduring the study period.
    •Subject who is currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months.
    •Subject who has the negative results both in skin test and the specific IgE test to house dust and mite antigens.
    •Subject who has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent.
    •Subject with severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor (symptom/disease assessed as grade 3 by severity grading of adverse drug reaction, MHLW Yaku-hatsu No. 80, 29 June 1992).
    •Subject has a history of malignancy or clinically important hematological disorder.
    •Subject has a history of severe drug allergy (e.g., anaphylactoid reaction).
    •Pregnant or lactating woman or woman who may be pregnant.
    •Subject has one or more of the following laboratory abnormalities. (1) AST and/or ALT >2 fold above the ULN (2) Serum creatinine >1.5 mg/dL in male and >1.3 mg/dL in female. (3) Positive urine pregnancy test in females who may be potential to be pregnant.
    •Subject is mentally or legally incompetent to give written assent/consent to participate in the study.
    •Subject is judged inappropriate for study by the investigator or sub-investigator.
    Visit 2/ Week 0/ at randomization
    •Before 7 days of randomization, subject with coexisting diseases which may affect nasal symptoms, e.g., acute upper respiratory tract infection, acute pharyngolaryngitis and acute tonsillitis.
    •Subject allergic to pollen (cedar, Japanese cypress, birch, gramineae, mugwort, common ragweed, etc.) in the specific IgE test or skin test for whom the pollen season coincides with the study period (at any time from 7 days prior to the randomization to the end of treatment).
    •Positive urine pregnancy test in female who may be potential to be pregnant.
    •Subject is judged inappropriate for study by the investigator or sub-investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints
    1.Change from baseline in total nasal symptom score assessed by (sub-) investigator at Week 2- Superiority of MK-4117 10 mg over placebo
    2.Change from baseline in total nasal symptom score assessed by (sub-) investigator at Week 2- Superiority of MK-4117 5 mg over placebo

    Safety endpoints
    1. Percentage of subjects with adverse experiences.
    2. Change from baseline in laboratory parameters at each time point. Baseline is defined as the evaluation at Visit 2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2 and throughout the study.
    E.5.2Secondary end point(s)
    1.Change from baseline in total nasal symptom score assessed by (sub-) investigator at Day 3, Week 1
    2.Change from baseline at Day 3, Week 1, Week 2 in:
    •Each nasal symptom score assessed by (sub-) investigator
    •Each nasal finding score assessed by (sub-) investigator
    •Eye (itching) symptom score assessed by (sub-) investigator
    •Interference with daily activities assessed by (sub-) Investigator
    3.Global improvement rate (the rate of moderate and more) assessed by (sub-) investigator at Day 3, Week 1, Week 2.
    4.Change from baseline in each nasal and eye (itching) score reported in Subjects Allergy Diary at Day 3, Week 1, Week 2
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 3, Week 1, Week 2
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Single blind during screening
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    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.8.9.2In all countries concerned by the trial months10
    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: 93
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 93
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 508
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 606
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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