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    Summary
    EudraCT Number:2018-002564-10
    Sponsor's Protocol Code Number:AP-CL-OTHER-PI-12868
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-23
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-002564-10
    A.3Full title of the trial
    Short-term safety, efficacy and mode of action of apremilast in mild to moderate cutaneous pemphigoid: a phase IIa open label single arm study.
    Korte termijn veiligheid, werkzaamheid en werkingsmechanisme van apremilast bij licht tot matig cutaan pemfigoïd: fase IIa open label onderzoek met één arm.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PDE4 inhibitor (apremilast) in pemphigoid.
    PDE4 inhibitor (apremilast) in pemfigoïd
    A.3.2Name or abbreviated title of the trial where available
    SAMP trial
    SAMP studie
    A.4.1Sponsor's protocol code numberAP-CL-OTHER-PI-12868
    A.5.4Other Identifiers
    Name:Trial Register Number:NTR7388
    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 SponsorUniversitair Medisch Centrum Groningen
    B.1.3.4CountryNetherlands
    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.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitair Medisch Centrum Groningen
    B.5.2Functional name of contact pointHanan Rashid
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0503610701
    B.5.6E-mailh.rashid@umcg.nl
    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 Limited
    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.3.2Product code CC-10004
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    Pemphigoid
    Pemfigoid
    E.1.1.1Medical condition in easily understood language
    Pemphigoid
    Pemfigoid
    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
    To evaluate the achievement of partial remission by apremilast combined with doxycycline at week sixteen (t=16).
    Evaluatie van het bereiken van gedeeltelijke remissie door apremilast gecombineerd met doxycycline in week zestien (t = 16).
    E.2.2Secondary objectives of the trial
    • Complete remission at week sixteen;
    • Disease control at week six (t=6);
    • Drug survival;
    • Clinical efficacy;
    • Mean decrease in periphery blood eosinophil count;
    • Mean decrease in BP180 Nc16a titers by ELISA;
    • Change in cytokine levels in blood and skin measured at baseline and week sixteen (t=0 and t=16);
    • Change in genexpression by RNA sequencing measured at t=0 and t=16.
    • Volledige remissie in week 16;
    • Disease control in week zes (t = 6);
    • Verdraagzaamheid van het geneesmiddel;
    • Klinische werkzaamheid;
    • Gemiddelde afname van het aantal eosinofielen in het perifere bloed;
    • Gemiddelde afname van BP180 Nc16a-titers met ELISA;
    • Verandering in cytokineniveaus in bloed en huid gemeten bij baseline en week zestien (t = 0 en t = 16);
    • Verandering in genexpressie door RNA-sequencing gemeten op t = 0 en t = 16.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult (≥ 18 years of age) male or female patients with recently diagnosed mild to moderate localized or generalized cutaneous pemphigoid, or patients that were in complete remission without treatment that have a mild to moderate flare-up of the disease.
    Volwassen (≥ 18 jaar) mannelijke of vrouwelijke patiënten met recent gediagnosticeerde mild tot matig lokaal of gegeneraliseerd cutaan pemfigoïd, of patiënten die in volledige remissie waren zonder behandeling met een milde tot matige opflakkering van de ziekte.
    E.4Principal exclusion criteria
    Women of childbearing potential without contraception; women who are pregnant or planning to become pregnant or who are lactating; patients that use systemic immunosuppressive medication; any condition which would make the patient unsuitable for treatment, or requires steroid use.

    Vrouwen in de vruchtbare leeftijd zonder anticonceptie; vrouwen die zwanger zijn of van plan zijn zwanger te worden of die borstvoeding geven; patiënten die systemische immunosuppressieve medicatie gebruiken; elke aandoening die de patiënt ongeschikt zou maken voor behandeling, of steroïde gebruik vereist.
    E.5 End points
    E.5.1Primary end point(s)
    Partial remission will be analysed in week sixteen (t=16). Partial remission is defined as presence of transient new lesions that heal within one week. At week six (t= 6), patients that showed no disease control on apremilast combined with doxycycline will be excluded from the pilot study. Disease control is defined as ‘the time that new lesions cease to form and established lesions begin to heal OR pruritic symptoms start to abate (minimal 3-point decrease of VAS)”.
    Gedeeltelijke remissie zal in week zestien (t = 16) worden geanalyseerd. Gedeeltelijke remissie wordt gedefinieerd als de aanwezigheid van voorbijgaande nieuwe laesies die binnen een week genezen. In week zes (t = 6) worden patiënten die geen disease vertonen op apremilast in combinatie met doxycycline ge-excludeerd van de pilotstudie. Disease control wordt gedefinieerd als 'de tijd dat nieuwe laesies ophouden te bestaan en vastgestelde laesies beginnen te genezen OF jeuk begint te verminderen (minimale daling van VAS met 3 punten)'.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Week 16
    E.5.2Secondary end point(s)
    • Achievement of complete remission at week sixteen. Complete remission is defined as absence of new or established lesions or pruritus.30
    • Proportion of patient with drug survival at t=16.
    • Proportion of patients with disease control at t=6.
    • Mean decrease in periphery blood eosinophil count.
    • Mean decrease in BP180 Nc16a titers by ELISA.
    • Change in cytokine levels in blood and skin measured at baseline and week sixteen (t=0 and t=16).
    • Change in genexpression by RNA sequencing measured at t=0 and t=16.

    The following outcomes will be used for measuring clinical efficacy:
    • mean reduction in Visual Analogue Scale (VAS)
    • mean decrease in Dermatology Quality of Life index (DLQI) and autoimmune blistering disease quality of life (AIBDQOL);
    • mean reduction of Bullous Pemphigoid Disease Area Index (BPDAI).
    • Bereiken van volledige remissie in week 16. Volledige remissie wordt gedefinieerd als de afwezigheid van nieuwe of vastgestelde laesies of pruritus.
    • Percentage van patiënt met disease control op t =16.
    • Percentage patiënten met disease control op t=6.
    • Gemiddelde afname van het aantal eosinofielen in het perifere bloed.
    • Gemiddelde afname van BP180 Nc16a-titers door ELISA.
    • Verandering in cytokineniveaus in bloed en huid gemeten bij baseline en week zestien (t = 0 en t = 16).
    • Verandering in genexpressie door RNA-sequencing gemeten op t = 0 en t = 16.

    De volgende uitkomsten zullen worden gebruikt voor het meten van de klinische werkzaamheid:
    • gemiddelde reductie in Visual Analogue Scale (VAS)
    • gemiddelde afname in Dermatology Quality of Life index (DLQI) en autoimmune blistering disease quality of life (AIBDQOL);
    • gemiddelde afname van de Bullous Pemphigoid Disease Area Index (BPDAI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 3, 6, 9 en 16
    Week 3, 6, 9 en 16
    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 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 Yes
    E.8.1.7.1Other trial design description
    een arm open studie
    single arm open series
    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

    The criteria for terminating the study prematurely:
    • Safety concerns based on reported data.
    • Inaccurate or incomplete data collection.
    • Falsification of records.
    LVLS

    De criteria om het onderzoek voortijdig te beëindigen:
    • Veiligheidszorgen op basis van gerapporteerde gegevens.
    • Onnauwkeurige of onvolledige gegevensverzameling.
    • Vervalsing van records.
    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 months
    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: 5
    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 No
    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 state10
    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
    Geen
    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 Decision2019-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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