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    EudraCT Number:2016-000859-27
    Sponsor's Protocol Code Number:HS_Apremilast
    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:2016-06-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-000859-27
    A.3Full title of the trial
    Efficacy and mode of action of apremilast (Otezla) in moderate hidradenitis suppurativa.
    An exploratory pilot study.
    Effectiviteit en mode of action van apremilast in matig-ernstige hidradenitis suppurativa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and mode of action of apremilast (Otezla) in moderate hidradenitis suppurativa.
    An exploratory pilot study.
    Effectiviteit en mode of action van apremilast in matig-ernstige hidradenitis suppurativa
    A.4.1Sponsor's protocol code numberHS_Apremilast
    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 SponsorErasmus University Medical Center
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene BV
    B.5.2Functional name of contact pointMedical Affairs NL
    B.5.3 Address:
    B.5.3.1Street AddressWinthontlaan 2
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3526 KV
    B.5.4Telephone number+313030 28 44 524
    B.5.5Fax number+313028 44 510
    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. name Apremilast (Otezla)
    D. of the Marketing Authorisation holderCelgene
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Hidradenitis suppurativa, acne inversa, ectopic acne
    Hidradenitis suppurativa, acne inversa, ectopisch acne
    E.1.1.1Medical condition in easily understood language
    Hidradenitis suppurativa, acne inversa, ectopic acne
    Hidradenitis suppurativa, acne inversa, ectopisch acne
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objectives: To evaluate the effects of apremilast on the expression of inflammatory cytokines in HS lesional skin at week one (t=1), week four (t=4) and week sixteen (t=16) relative to baseline (t=0), in relation to its clinical efficacy.
    Primaire doel: Om de effecten van apremilast op de expressie van inflammatoire cytokines in de door HS aangedane huid te evalueren in relatie tot de klinische werkzaamheid in week één (t= 1), week vier (t = 4) en week zestien (t = 16) ten opzichte van baseline (t = 0 ) .
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - To prospectively evaluate the clinical efficacy of apremilast.
    - To assess the effect of apremilast on patient reported outcomes measures.
    - To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.
    Secundaire doelstellingen:
    - Om de klinische werkzaamheid van apremilast prospectief te evalueren.
    - Om het effect van apremilast op de door patiënt gerapporteerde uitkomsten te beoordelen.
    - Om de korte termijn veiligheid en verdraagzaamheid van apremilast bij patiënten met hidradenitis suppurativa te beoordelen (in het kader van off label gebruik)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion criteria: adult (≥ 18 years of age) male or female patients with moderate HS according to a PGA of 3 on the 5-point HS-Physician Global Assessment (HS-PGA); HS of more than 6 months duration; have lesions in at least two anatomical locations.
    Belangrijkste inclusiecriteria: volwassen (≥ 18 jaar) mannelijke of vrouwelijke patiënten met matig-ernstige HS volgens een PGA van 3 op de 5-punts HS-Physician Global Assessment (HS-PGA); een duur van HS van meer dan 6 maanden; HS-laesies in ten minste twee anatomische regio's.
    E.4Principal exclusion criteria
    Key exclusion criteria: contraindication for apremilast; previous use of apremilast; have any current and/or recurrent clinically significant skin condition in the treatment area other than HS; presence of other uncontrolled major disease; pregnant or lactating women.
    Belangrijkste exclusiecriteria: contra-indicatie voor apremilast; eerder gebruik van apremilast; een thans aanwezige of recidiverende klinisch significante aandoening van de huid in het te behandelen gebied anders dan HS; aanwezigheid van een ernstige (actieve) zich openbarende ziekte; zwangere vrouwen of vrouwen die borstvoeding geven.
    E.5 End points
    E.5.1Primary end point(s)
    The expression levels of inflammatory cytokine protein and mRNA in HS lesional skin will be analyzed at week one (t=1), week four (t=4) and week sixteen (t=16) relative to baseline (t=0), in relation to its clinical efficacy. The proteins and genes of interest to be measured are IL-1β, IL-6, TNF-α, IL-10, IL-12, IL-23, IL-17, IFN-γ, IL-31. Exactly the same cytokines will be measured using ELISA and qPCR in order to correlate the data.
    De expressieniveaus van inflammatoire cytokines (eiwit en mRNA) in de door HS aangedane huid zal worden geanalyseerd in week één (t = 1), week vier (t = 4) en week zestien (t = 16) en vergeleken ten opzichte van baseline (t = 0), tezamen in relatie tot de klinische werkzaamheid.
    De eiwitten en genen van belang te meten zijn IL-1β, IL-6, TNF-α, IL-10, IL-12, IL-23, IL-17, IFN-γ, IL-31. De gebruikte onderzoekstechnieken zijn ELISA en qPCR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week one (t=1), week four (t=4) and week sixteen (t=16) relative to baseline (t=0),
    week 0, week 1, week 4, week 16
    E.5.2Secondary end point(s)
    The clinical efficacy will be measured using the following scoring systems:
    • Individual inflammatory lesion count (Appendix 3)
    • HS-Physician Global Assessment (HS-PGA)(16) (Appendix 4)
    • Hidradenitis Suppurativa Clinical Response (HiSCR) (17) (Appendix 5)

    The patient reported outcomes will be measured using the following scoring sytems:
    • NRS to assess pain, pruritus and patient disease global assessment score (Appendix 6, 7, 8)
    • DLQI (18) (Appendix 9)
    Voor gedetailleerde weergave zie Appendix 3 tot 9 van het studieprotocol

    De klinische efficitivieit zal worden gemeten met behulp van de volgende scoring-systemen
    • Individuele inflammatoire laesie telling
    • HS-Physician Global Assessment (HS-PGA)
    • Hidradenitis suppurativa klinische respons score (HiSCR)

    De patiënt gerapporteerde uitkomsten zullen worden gemeten aan de hand van de volgende scoresysteem:
    • NRS om pijn, jeuk en de patiënt de ziekte globale beoordeling score te beoordelen
    • DLQI
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 0, 2, 4, 8, 12, 16
    week 0, 2, 4, 8, 12, 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 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. 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 No
    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 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
    Last visit is visit 8, i.e. at week 16
    laatste visitie is visite 8, d.w.z. op week 16
    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 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: 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 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)
    Supply is requested for those patients who respond to the treatment with apremilast, until the patient no longer benefits from continued treatment with apremilast, as determined by the investigator/ treating physician.
    Levering van apremilast wordt aangevraagd voor degenen die op de behandeling met apremilast reageren, totdat de patient niet langer voordeel heeft van voortzetten van de behandeling met apremilast, wat wordt bepaald door de onderzoeker/behandelend arts.
    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 Decision2016-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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