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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-005024-42
    Sponsor's Protocol Code Number:TCP-102
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-005024-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Study of the Neurokinin-1 Receptor Antagonist VPD-737 in Subjects with Prurigo Nodularis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Neurokinin-1 Receptor Antagonist VPD-737 in Subjects with Prurigo Nodularis
    A.3.2Name or abbreviated title of the trial where available
    Study of the Neurokinin-1 Receptor Antagonist VPD-737 in Subjects with Prurigo Nodularis
    A.4.1Sponsor's protocol code numberTCP-102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01951274
    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 SponsorMenlo Therapeutics, 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 supportTigercat Pharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMenlo Therapeutics, Inc.
    B.5.2Functional name of contact pointAndrew Lane
    B.5.3 Address:
    B.5.3.1Street Address4085 Campbell Avenue 2nd Floor
    B.5.3.2Town/ cityMenlo Park
    B.5.3.3Post codeCA 94025
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16504861416
    B.5.5Fax number+16502490205
    B.5.6E-mailandrew@menlotx.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 nameSerlopitant
    D.3.2Product code VDP-737
    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 INNSerlopitant
    D.3.9.1CAS number 860642-69-9
    D.3.9.2Current sponsor codeVDP-737
    D.3.9.3Other descriptive nameSERLOPITANT
    D.3.9.4EV Substance CodeSUB130838
    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
    Pruritus nodularis
    E.1.1.1Medical condition in easily understood language
    Pruritus nodularis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    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 objectives of this study are to evaluate the efficacy and safety of VPD-737 5-mg tablets and the placebo taken orally once daily for 8 weeks for the treatment of prurigo nodularis (PN).
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females who are at least 18 years and no more than 80 years of age at Screening.
    2. Must have PN (defined as the presence of pruritic nodules due to chronic pruritus,) of more than 6 weeks duration despite treatment with current therapies such as antihistamines or corticosteroids (“treatment resistant” PN).

    3. Must have PN lesions on both arms, both legs, and/or the trunk (ie, the lesions must not be localized).
    4. Must have a VAS pruritus score of 70 or greater within 72 hours of Baseline.
    5. Males, non-fecund females (ie, surgically sterilized, if procedure was done 12 months before screening or subject is postmenopausal, without menses for 12 months before screening), or females of childbearing potential using an acceptable method of birth control for a period of 35 days before the first dosing, and all females must have a negative pregnancy test at the screening and baseline visits:
    Note 1: Acceptable methods of birth control include any one of the following: abstinence, vasectomized sexual partner, hormonal methods (ie, birth-control pill, hormonal IUD, Depo-Provera, implants, patch, intravaginal device [NuvaRing]), intrauterine device (IUD [copper banded coils]), diaphragm, cervical cap, or condom with spermicidal jelly or foam. Subjects using oral contraceptives must also use a reliable backup method of birth control during the study and until the first menses after the last dose of study medication or for 14 days menses after the last dose of study medication.
    6. Willing and able to understand and provide written informed consent.
    7. Willing and able to comply with study requirements and restrictions including the discontinuation of all current therapies for pruritus.
    8. Subjects must be in good health as determined by medical history, physical examination, and results of ECG and clinical laboratory tests (including urinalysis).
    9. Agreeing to confidential use and storage of all data and use of all anonymized data for publication including scientific publication.
    E.4Principal exclusion criteria
    1Have chronic pruritus due conditions other than PN, such as the following conditions: Lichen simplex chronicus, Lichen amyloidosus, Localized pruritus (e.g., only one arm affected), Neuropathic and psychogenic pruritus (notalgia paresthetica, brachioradial pruritus, somatoform prurigo, dilusional parasitosis, depression associated prurigo), Active dermatoses needing immediate therapy such as atopic dermatitis (without PN) or bullous pemphigoid;
    2Have a history of use (within the specified time periods) of the medications listed below. Prior to randomization, a subject who used any of these medications must undergo a washout period equal to the length of the interval specified below (eg, 5 days for antihistamines, 2 weeks for naltrexone, and 2 weeks for cyclosporine A).
    - topical or systemic antihistamines, (used ≤5 days prior to the baseline visit) [loratindine, or cetirizine may act as rescue medication during treatment];
    - topical calcineurin inhibitors, topical capsaicin, menthol, camphor, polidocanol, topical antibiotics, antiseptic baths and cleansing lotions (used ≤1 week prior to the baseline visit);
    - topical steroids (used ≤2 weeks prior to the baseline visit);
    - naltrexone, paroxetine, fluvoxamine, amitriptyline, gabapentin, pregabalin, or UV-therapy (prescribed for the pruritus treatment) (used ≤2 weeks prior to the baseline visit);
    - systemic steroids (used ≤2 weeks prior to the baseline visit);
    - cyclosporine A and other immunosuppressants (used ≤2 weeks prior to the baseline visit).
    3Have any medical condition or disability that would interfere with the assessment of safety or efficacy in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
    4Have any chronic or acute medical condition that, in the opinion of the investigator, might interfere with the study results or place the subject at undue risk.
    5Have a history of sensitivity to any components of the study material.
    6Are females of childbearing potential who are unwilling to use adequate contraception or who are breast feeding.
    7Have chronic renal disease, ie, serum creatinine greater than 2.4 mg/dL.
    8Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal. Subjects with hepatitis B or C who have normal liver function may be enrolled.
    9Have a current malignancy (such as Hodgkin’s lymphoma, B or T cell lymphoma, or myeloma) or blood cell dyscrasia (eg, polycythemia or myelofibrosis) that might lead to systemic chronic pruritus.
    10Subjects with untreated hyperthyroidism.
    11Have pruritus of psychiatric etiology (eg, delusions of parasitosis, obsessive compulsive disorder, or major depression) or neuropathic etiology (eg, due to shingles, spinal cord injury or with neurologic deficit).
    12Have pruritus due to urticaria, drug allergy, or infection (such as pityriasis rosea or tinea or active human immunodeficiency virus [HIV]). Note: Subjects with HIV who have undetectable viral load, CD 4 counts >200 cells/cc, and stable retroviral therapy may enroll.
    13Are on medications known to cause pruritus (ie, Erbitux®, opioids, cocaine, amphetamines, and angiotensin converting enzyme [ACE] inhibitors) and are suspected of having drug-induced pruritus.
    14Have taken investigational medications within 30 days prior to Screening.
    15Are currently participating in any other clinical study.
    16Have a history (within the previous 2 weeks) of use of tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRIS), monoamine oxidase (MAO) inhibitors, opioids, immune-modulators (e.g. azathioprine, methotrexate, mycophenolate mofetil, cyclosporine A, antibodies), or neuroactive medications (e.g. pregabalin, gabapentin)[...].
    17Have a history (within the previous 4 weeks) of use of sedatives or tranquilizers. Subjects must undergo an appropriate washout period from any sedatives or tranquilizers before enrolling in the study.
    18Are currently treated with strong CYP3A4 inhibitors (e.g. conazole, ketoconazole, fluconazole, itraconazole, voroconazole etc. or erythromycin). The co-administration of moderate CYP3A4 inhibitors to VPD-737 may be allowed with investigator agreement and appropriate safety monitoring.
    19Received ultraviolet B (UVB) or psoralen + ultraviolet A (PUVA) treatment within ≤2 weeks prior to Baseline.
    20Within the past 12 months, have expressed suicidal ideation with some intent to act.
    21Started or changed creams, or emollients including over-the-counter (OTC) preparations or bath oil treatment for relief of pruritus within 1 week prior to Screening.
    22Have any social or medical condition (eg, alcoholism, drug dependency, psychotic state) that, in the investigator’s opinion, might interfere with the subject’s ability to comply with the requirements of the protocol.
    23Are employees of the study site or of the Sponsor’s company.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this double-blind, randomized clinical trial are pairwise comparisons between treatments of the VAS score (average over a 24 hour period) and the safety and tolerability of VPD 737 5-mg tablets and the placebo taken orally once daily for 8 weeks for the treatment of prurigo nodularis (PN).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoints of this double-blind, randomized clinical trial are pairwise comparisons between treatments of the VAS score (average over a 24 hour period) and the safety and tolerability of VPD 737 5-mg tablets and the placebo taken orally once daily for 8 weeks for the treatment of prurigo nodularis (PN).
    E.5.2Secondary end point(s)
    • Mean change from Baseline in VRS, VAS (worst), patient global assessment score, dynamic score, and NRS.
    • Mean change from Baseline in Quality of Life questionnaire results (Dermatology Life Quality Index (DLQI)/ Pruritus specific Quality of Life (ItchyQoL)); The DLQI/ItchyQoL will be scored according to the Instrument developers rules
    • Mean change from Baseline in the Patient Benefit Index, Version for Patients with Pruritus (PBI-P) questionnaire results;
    • Mean change from Baseline in PN skin lesions as measured by the Prurigo Activity Score (PAS);
    • Mean change from Baseline in the Investigator Global Assessment (IGA);
    • Time course of changes in VRS, NRS and VAS scores;
    • Percentage of patients in each group requiring rescue medication with loratadine or cetirizine.
    Safety will assessed using adverse events, serious adverse events, premature discontinuations from study, electrocardiograms, vital signs, abbreviated physical exams, and blood and urine laboratory tests.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints are descriptive pairwise comparisons between the VPD and placebo
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 trial2
    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 concerned16
    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
    LVLS
    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 months24
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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.4.1In the member state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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 Decision2014-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-08
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