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    Summary
    EudraCT Number:2018-002978-52
    Sponsor's Protocol Code Number:CNTO1959HDS2002
    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:2019-06-26
    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 number2018-002978-52
    A.3Full title of the trial
    Guselkumab for hidradenitis suppurativa, a mode of action study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Guselkumab for the treatment of hidradenitis suppurativa
    Guselkumab voor de behandeling van hidradenitis suppurativa
    A.3.2Name or abbreviated title of the trial where available
    HiGUS trial
    A.4.1Sponsor's protocol code numberCNTO1959HDS2002
    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 supportJanssen-Cilag B.V.
    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 pointLisette Prens
    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 number+310503612520
    B.5.6E-maill.m.prens@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 Tremfya
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 nameGuselkumab
    D.3.2Product code CNTO 1959
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Hidradenitis suppurativa
    Hidradenitis suppurativa
    E.1.1.1Medical condition in easily understood language
    Hidradenitis suppurativa
    Hidradenitis suppurativa
    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
    To investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin at week 16 compared to baseline (t=0).
    Om veranderingen in inflammatoire pathways geïnduceerd door IL-23p19 blokkade met guselkumab te onderzoeken, in HS lesionale huid op week 16 vergeleken met baseline (t=0)
    E.2.2Secondary objectives of the trial
    - To determine the efficacy of 4 doses of guselkumab of 200 mg at week 0, 4, 8 and 12 in moderate to severe chronic hidradenitis suppurativa patients, by clinical response rate at week 16
    - To assess the short-term the safety and tolerability of guselkumab 200 mg in moderate to severe chronic hidradenitis suppurativa patients at week 16.
    - To assess the effect of guselkumab on patient reported outcomes measures.
    - To assess effect of guselkumab changes in levels of inflammatory cytokines and other biomarkers in the peripheral blood.
    - Bepalen van de effectiviteit van vier doses van guselkumab 200 mg op week 0, 4, 8 en 12 in matige tot ernstige chronische hidradenitis suppurativa patienten, door klinische respons op week 16.
    - Onderzoeken van de korte termijn veiligheid en verdraagzaamheid van guselkumab 200 mg in in matige tot ernstige chronische hidradenitis suppurativa patienten op week 16
    - Onderzoeken van het effect van guselkumab op patiënt gerapporteerde uitkomstmaten.
    - Onderzoeken van het effect van guselkumab op veranderingen van waardes van inflammatoire cytokines en andere biomarkers in het perifere bloed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult (≥ 18 years of age) male or female patients with moderate to severe HS (i.e. a PGA of 3 or more) with a treatment history of at least one systemic anti-inflammatory / immunosuppressive agent; HS diagnosis of at least 1 year; minimum of two anatomical locations with HS lesions and a minimum of 4 active abscesses and/or inflammatory nodules (AN).
    Volwassen mannelijke of vrouwelijke patiënten met matig tot ernstige hidradenitis suppurativa (HS), die tenminste één systemische anti-inflammatoire / immunosuppressieve behandeling hebben gehad. HS diagnose gedurende tenminste 1 jaar; minimaal twee anatomische locaties met HS laesies en een minimum van 4 actieve abcessen en/of inflammatoire nodi (AN).
    E.4Principal exclusion criteria
    contra-indication for guselkumab; previous use of guselkumab; use of treatment with biologics or any immunosuppressives for HS in the last 3 months prior to randomization; presence of other uncontrolled major disease; pregnant or lactating women.
    Contra-indicatie voor guselkumab; eerder gebruik van guselkumab; behandeling met biologicals of een andere immuunsuppressieve therapie voor HS in de laatste 3 maanden voorafgaand aan randomisatie; aanwezigheid van een niet gecontroleerde grote aandoening; zwangere of borstvoedinggevende vrouwen.
    E.5 End points
    E.5.1Primary end point(s)
    A. Expression levels of inflammatory cytokine protein and mRNA in HS lesional skin.
    B. Alterations in serum protein profile (using SOMAscan, Luminex or Olink)
    A. Expressie niveaus van inflammatoire cytokine eiwitten en mRNA in aangedane HS huid.
    B. Verandering in het serum eiwit profiel (gebruikmakend van SOMAscan, Luminex of Olink)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Week 16
    E.5.2Secondary end point(s)
    Clinical efficacy:
    • Reduction in total AN count
    • Hidradenitis Suppurativa Clinical Response (HiSCR)
    • Mean reduction in International Hidradenitis Suppurativa Severity Score System (IHS4)
    D. Patient reported outcomes measures:
    • Change in Patient global assessment,
    • Mean reduction on the Pain Numeric Rating Scale (pain NRS) to assess pain
    • Mean reudciton on the Itch Numeric Rating Scale (itch NRS) to assess itch
    • Mean decrease in Dermatology Life Quality Index (DLQI) and Hidradenitis Suppurativa Quality of Life (HS-QoL)

    E. Safety and tolerability:
    • Vital signs, adverse events, safety laboratories
    Klinische effectiviteit:
    - Afname in totale AN aantal
    - Hidradenitis Suppurativa Clinical Response (HiSCR)
    - International Hidradenitis Suppurativa Severity Score System (IHS4)

    D. Patient gerapporteerde uitkomstmaten:
    - Globale patient evaluatie (Patient global assessment)
    - Afname in pijn, gemeten op de Pain Numeric Rating Scale (pain NRS)
    - Afname in jeuk, gemeten op de Itch Numeric Rating Scale (itch NRS)
    - Afname in score op de Dermatology Life Quality Index (DLQI)
    Afname in score op de Hidradenitis Suppurativa Quality of Life (HS-QoL)

    E. Veiligheid en verdraagzaamheid:
    • Vital parameters, adverse events, routine bloedonderzoek
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (week 0), week 4, 12 and 16
    Baseline (week 0), week 4, 12 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 Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    The criteria for terminating the study prematurely:
    • Safety concerns based on reported data.
    • Inaccurate or incomplete data collection.
    • Falsification of records.
    De criteria voor het voortijdig beëindigen van de studie:
    - Zorgen met betrekking tot de veiligheid gebaseerd op gerapporteerde data
    - Inaccurate of incomplete data collectie
    - Falsificatie van data.
    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 months12
    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: 20
    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 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)
    After the study is finished patients will return to the standard care protocol.
    Na de studie zullen de patiënten terugkeren naar de standaard zorg volgens protocol.
    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 Decision2019-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
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