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    Summary
    EudraCT Number:2016-003018-29
    Sponsor's Protocol Code Number:2016-003018-29
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-03
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-003018-29
    A.3Full title of the trial
    Apremilast as anti-pruritic treatment in patients with prurigo nodularis
    Kan apremilast reducere kløe hos patienter med prurigo nodularis?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Apremilast as anti-pruritic treatment in patients with prurigo nodularis
    Kan apremilast reducere kløe hos patienter med prurigo nodularis?
    A.4.1Sponsor's protocol code number2016-003018-29
    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 SponsorHerlev and Gentofte Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerlev and Gentofte Hospital
    B.5.2Functional name of contact pointDept of Dermatology and Allergy
    B.5.3 Address:
    B.5.3.1Street AddressKildegaardsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538673203
    B.5.5Fax number004538677615
    B.5.6E-mailclaus.zachariae@regionh.dk
    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 Otezla
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe 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.3.1Product nameapremilast
    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 INNapremilast
    D.3.9.1CAS number 608141-41-9
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 2
    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 Otezla
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe 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.3.1Product nameapremilast
    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 INNapremilast
    D.3.9.1CAS number 608141-41-9
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prurigo nodularis
    Prurigo nodularis
    E.1.1.1Medical condition in easily understood language
    Prurigo nodularis
    Prurigo 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
    This study will evaluate the anti-pruritic effect of apremilast in patients with known PN.

    1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast
    Dette er et interventionsstudie, hvor vi vil vurdere effekten af apremilast mod kløe til patienter med kendt prurigo nodularis.

    • Reduktion i absolutte mean VAS-kløe (bilag 1) efter behandling med apremilast i 12 uger sammenlignet med mean VAS-kløe før behandling med apremilast.
    E.2.2Secondary objectives of the trial
    1. Reduction in PGA score after 12 weeks treatment with apremilast compared to PGA score before treatment with apremilast. A decrease in PGA score of at least 2 points from baseline level will be considered as a successful reduction
    2. Reduction in DLQI score after 12 weeks treatment with apremilast compared DLQI score before treatment with apremilast
    3. Reduction in PtGA score after 12 weeks treatment with apremilast compared to PtGA score before treatment with apremilast
    4. Improvement in sleep quality after 12 weeks treatment with apremilast compared to sleep quality before treatment with apremilast using a self-administered questionnaire.
    5. Reduction in level of inflammatory cytokines in blood after 12 weeks treatment with apremilast compared to inflammatory cytokine level before treatment with apremilast
    6. Increase in level of IL-10 (anti-inflammatory cytokine) in blood after 12 weeks treatment with apremilast compared to IL-10 level before treatment with apremilast
    • Reduktion i PGA score efter behandling med apremilast i 12 uger sammenlignet PGA score før behandling med apremilast. Et fald i PGA score på mindst 2 point fra baseline level vil blive betragtet som et positivt resultat.
    • Reduktion i DLQI score efter behandling med apremilast i 12 uger sammenlignet med DLQI score før behandling med apremilast
    • Reduktion i PtGA score efter behandling med apremilast i 12 uger sammenlignet med PtGA score før behandling med apremilast
    • Forbedret søvnkvalitet efter behandling med apremilast i 12 uger sammenlignet søvnkvalitet før behandling med apremilast. Monitoreres ved spørgeskema (PSQI) omhandlende søvnkvalitet
    • Reduktion i antal af inflammatoriske cytokiner i blod efter behandling med apremilast i 12 uger sammenlignet med antal af inflammatoriske cytokiner før behandling med apremilast.
    • Stigning i IL-10 i blod efter behandling med apremilast i 12 uger sammenlignet IL-10 niveau før behandling med apremilast

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • > 18 years of age
    • PN verified diagnosis by characteristic clinical features
    • Moderate to severe PN
    • Failure of local steroid and light treatment to control disease and symptoms.
    • Be able to speak and understand Danish.
    • Patients must have given their informed consent to the protocol and to the clinical procedures.
    1. Kvinder og mænd, som er mindst 18 år på screeningstidspunktet.
    2. Klinisk diagnosticeret moderat til svær prurigo nodularis
    3. Utilstrækkeligt respons på lokalsteroid og lysbehandling
    4. Patienten skal være i stand til at kommunikere med forsøgslægen og opfylde de betingelser forsøget stiller
    5. Afgive skriftligt samtykke, før forsøgsrelaterede procedurer kan påbegyndes.
    E.4Principal exclusion criteria
    • Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0
    • Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0
    • Patients who have received any other study medication 4 weeks prior to day 0
    • Patients with other clinically significant disorders
    • Patients with active TB/serious infections
    • Any psychiatric condition which in the Investigators opinion would preclude the patient from adhering to the protocol or completing the study per protocol
    • Pregnancy
    • Nursing
    • Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception.
    • Patients who have received any live vaccines 6 weeks prior to day 0 or who are planning to receive a live vaccine during the study
    1. Behandling med lokal antiinflammatorisk medicin inden for 2 uger før forsøgets påbegyndelse
    2. Behandling med systemisk antiinflammatorisk medicin inden for 4 uger før forsøgets påbegyndelse
    3. Behandling med forsøgsmedicin inden for 4 uger før baseline
    4. Gravide eller ammende kvinder
    5. Fertile kvinder skal anvende sikker prævention i hele forsøgsperioden og op til 16 uger efter behandlingsstop med apremilast. Sikker prævention er p-piller, spiral, depotindsprøjtning af gestagen, hormonstav indsat under huden, hormonal vaginalring, depotplaster, pessar eller kondom med sæddræbende creme. Sterilitet eller overgangsalder som er stoppet for mere end 12 måneder siden fritages for prævention.
    6. Patienter med alvorlige kendte sygdomme
    7. Patienter med moderat til svær depression, selvmordtanker, selvmordsadfærd eller anden psykisk sygdom, som af forsøgslægen vurderes uegnet til at deltage.
    8. Patienter kendt med aktiv tuberkulose eller alvorlige infektiøse sygdomme.
    9. Planlagt levende vaccine under forsøget eller 6 uger før baseline.

    E.5 End points
    E.5.1Primary end point(s)
    Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast
    Reduktion i absolutte mean VAS-kløe (bilag 1) efter behandling med apremilast i 12 uger sammenlignet med mean VAS-kløe før behandling med apremilast.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12/2019
    12/2019
    E.5.2Secondary end point(s)
    Please see section E2
    Se venligst sektion E2
    E.5.2.1Timepoint(s) of evaluation of this end point
    12/2019
    12/2019
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    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 months0
    E.8.9.1In the Member State concerned 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: 10
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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
    Ingen
    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 Decision2017-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-27
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