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    Summary
    EudraCT Number:2017-000608-13
    Sponsor's Protocol Code Number:MK-4117-201
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-02-09
    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 number2017-000608-13
    A.3Full title of the trial
    A phase III multicentre, parallel-group, randomized, placebo-controlled, double-blind clinical trial to study the efficacy and safety of MK-4117 in Japanese subjects with chronic urticaria.
    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 chronic urticaria (a skin condition caused by an allergy)
    A.3.2Name or abbreviated title of the trial where available
    A Phase III clinical trial of MK-4117 in Japanese subjects with chronic urticaria
    A.4.1Sponsor's protocol code numberMK-4117-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01916967
    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.3.9.3Other 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
    Chronic urticaria (a skin condition caused by an allergy)
    E.1.1.1Medical condition in easily understood language
    Chronic urticaria (a skin condition caused by an allergy)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10052568
    E.1.2Term Urticaria chronic
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 sum score of pruritus/itch (the higher one in either daytime or nighttime) and rash (overall assessment of rash) assessed by (sub-) investigator at Week 2 for:
    a.MK-4117 10 mg group with placebo group, respectively.
    b.MK-4117 5 mg group with placebo group, respectively.
    2) To evaluate the safety and tolerability of MK-4117 10 mg and 5 mg administered once daily for 2 weeks.
    E.2.2Secondary objectives of the trial
    For MK-4117 10 mg and 5 mg groups versus placebo group, to compare:
    1)change from baseline in:
    a.sum score of pruritus/itch (the higher one in either daytime or nighttime) and rash (overall assessment of rash) assessed by (sub-) investigator at Day 3 and Wk 1
    b.each score of pruritus/itch (daytime, nighttime, the higher one in either daytime or nighttime, sum score of daytime and nighttime) and rash (erythema, wheal, overall assessment of rash, sum of erythema and wheal) score assessed by (sub-) investigator at Day 3, Wk 1 and 2
    c.the degree of pruritus recorded by subjects at Day 3, Wk 1 and 2
    d.each pruritus/itch score (daytime, nighttime, the higher one in either daytime or nighttime, sum score of daytime and nighttime) and rash score (erythema, wheal, sum of erythema and wheal) reported in subject diary at Day 3, Wk 1 and 2
    2) % of subjects with moderate to remarkable improvement in 5 ratings of global improvement rate assessed by (sub-) investigator at Day 3, Wk 1 and 2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Visit 1 / Screening
    1. Chronic urticaria subject [Subject who has rash (erythema, wheal) more than 1 month without any known cause, and who expected to meet the inclusion criteria #7 at Visit 2 based on pruritus/itching and rash scores.
    2. Out- patients.
    3. Subject who can make entries in the subject diary or has a legal representative who can make entries.
    4. Subject is 12 years and older when informed consent is given.
    5. 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 undergones 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 women≥46 years of age) (3) Subject is of reproductive potential and agrees to (1) remain abstinent or (2) use (orhave their partner use) 2 adequate barrier methods of contraception to prevent pregnancy within the projected duration of the study (from giving written informed consent) and for 14 days after the last dose of study medication. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, condom (male partner), vasectomy (male partner), hormonal contraceptives.
    6. 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.

    Visit 2/ Week 0/ at randomization
    7. Subject having symptoms to a degree allowing the evaluation of the study drug. Based on the following criteria, subject who was judged severity of dermatological symptoms by investigator or sub-investigator and met both requirements of pruritus/itch and rash (erythema, wheal) will be enrolled.
    (1) Pruritus/itch Pruritus/itch score in both during day and night by subject interview/diary should be assessed using the criteria in the protocol. The subjects with score 2 or above for either or both of daytime and nighttime scores can be enrolled in this study. Mild severity is assessed as score 2.
    (2) Rash (erythema, wheal) The severity of erythema and wheal should be assessed using the criteria as in the protocol by the investigator . The subjects who met both of following requirements will be
    enrolled in this study. Mild severity is assessed as score 2.
    1) Either erythema score or wheal score: 2 (mild) and over
    2) Overall assessment of rash score: 2 (mild) and over
    E.4Principal exclusion criteria
    Visit 1/ Screening
    1. Subject with stimulation-induced urticaria [e.g., physical urticaria (e.g., cold, solar and heat urticaria), cholinergic urticaria, contact urticaria].
    2. Subjects for whom the period of discontinuation of previous treatment before the start of study drug administration indicated in the protocol is not adequate.
    3. Subject with a history of hypersensitivity to antihistamines or ingredients of study drug.
    4. Subject who is currently receiving treatment with another study drug or has received a study drug in the past 3 months.
    5. Subject who need prohibited drugs (see Section 5.5.1).
    6. 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).
    7. Subject has a history of malignancy or clinically important hematological disorder.
    8. Subject has a history of severe drug allergy (e.g., anaphylactoid reaction).
    9. Pregnant or lactating woman or woman who may be pregnant.
    10. Subject has one or more of the following laboratory abnormalities.
    a) AST and/or ALT >2 fold above the ULN
    b) Serum creatinine >1.5 mg/dL in male and >1.3 mg/dL in female.
    c) Positive pregnancy test (Urinary hCG) in females who may be potential to be pregnant.
    11. Subject is mentally or legally incompetent to give written consent to participate in the study.
    12. Subject is judged inappropriate for study by the investigator or sub-investigator.

    Visit 2/ Week 0/ at randomization
    13. Subject for whom the period of discontinuation of previous treatment before the start of study drug administration indicated in the protocol is not enough.
    14. Subject has a positive pregnancy test (Urinary hCG) at Visit 2.
    15. Subject is judged inappropriate for study by the investigator or sub-investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: 1.) Change from baseline in sum score of pruritus/itch (the higher one in either daytime or nighttime) and rash (overall assessment of rash) assessed by (sub-) investigator at Week 2 for MK-4117 10 mg group with placebo group, respectively; and 2.) Change from baseline in sum score of pruritus/itch (the higher one in either daytime or nighttime) and rash (overall assessment of rash) assessed by (sub-) investigator at Week 2 for MK-4117 5 mg group with placebo group, respectively.
    Safety: 3.) Percentage of subjects with adverse experiences; and Change from baseline in laboratory parameters at each visit. Baseline is defined as the evaluation at Visit 2
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: Week 2
    Safety: at each visit
    E.5.2Secondary end point(s)
    1.) Change from baseline in sum score of pruritus/itch (the higher one in either daytime or nighttime) and rash (overall assessment of rash) assessed by (sub-) investigator at Day 3 and Week 1 for MK-4117 10 mg and 5 mg groups with placebo group; 2.) Change from baseline in each score of pruritus/itch (daytime, nighttime, the higher one in either daytime or nighttime, sum score of daytime and nighttime) and rash (erythema, wheal, overall assessment of rash, sum of erythema and wheal) score assessed by (sub-) investigator at Day 3, Week 1 and Week 2 for MK-4117 10 mg and 5 mg groups with placebo group, respectively; 3.) Change from baseline in the degree of pruritus recorded by subjects (VAS [visual analogue scale ] [100 mm]) at Day 3, Week 1 and Week 2 for MK-4117 10 mg and 5 mg groups with placebo group, respectively; 4.) Percent 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, respectively; 5.) Change from baseline in each pruritus/itch score (daytime, nighttime, the higher one in either daytime or nighttime, sum score of daytime and nighttime) and rash score (erythema, wheal, sum of erythema and wheal) reported in subject diary at Day 3, Week 1 and Week 2 for MK-4117 10 mg and 5 mg groups with placebo group, respectively.
    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 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 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: 11
    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: 11
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 205
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 239
    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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