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    Summary
    EudraCT Number:2017-000435-13
    Sponsor's Protocol Code Number:JWGKDVAAP0117
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-16
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-000435-13
    A.3Full title of the trial
    Exploratory study to evaluate changes in inflammatory pattern and analysis for serum biomarkers in patients with active, moderate-to-severe hidradenitis suppurativa after 2-week and 6-week treatment with a TNF-alpha Inhibitor.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to examine changes in inflammational type of active, moderate-to-severe hidradenitis suppurativa during a 6-week treatment with the approved medication Adalimumab (HUMIRA).
    A.4.1Sponsor's protocol code numberJWGKDVAAP0117
    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 SponsorUniversity Hospital Frankfurt for its Dermatology Department, Clinical Research
    B.1.3.4CountryGermany
    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 supportAbbVie Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDermatology Department, University Hospital Frankfurt
    B.5.2Functional name of contact pointClinical Research KDVA
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt/Main
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number0049696301 5418
    B.5.5Fax number0049696301 83175
    B.5.6E-mailandreas.pinter@kgu.de
    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 HUMIRA
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd Maidenhead SL6 4UB, UK
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameHUMIRA
    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) 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) Yes
    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.3.11.13.1Other medicinal product typeIn SmPC type of product has been mentioned as immunosupressant
    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 is defined as a chronic inflammatory disease of the intertriginous area, including the axilla, groin and anogenital or submammary regions. The condition is characterized by inflammation, recurrent abscesses, fistulas and sinus tracts, leading to post-inflammatory contracture and accordion-like mutilating scars. Mostly this disease appears in younger patients from 15 - 45 years and is connected with a high burden of disease and decreased quality of life.
    E.1.1.1Medical condition in easily understood language
    Hidradenitis suppurativa is a chronic skin disease which affects the axilla and groin. This disease is common and furthermore connected with a low quality of life and other organic comorbidity.
    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
    Considering that HS is a severe progressive disease that requires tight control and that might be under diagnosed, this prospective, open-label study provides a deeper view into the pathophysiological mechanism of HS and is furthermore aligned to detect potential biomarkers. Such biomarkers could allow researchers to predict early on whether anti-TNF-alpha treated patients will respond to anti-inflammatory therapy or not, even before clinical improvement can be seen.

    The Co-primary objective will be:

    • To analyze the pattern of inflammatory cytokines in patients with moderate-to-severe HS before treatment with a TNF-alpha antagonist.

    • To evaluate changes (quantitative) in the pattern of inflammatory cytokine expression in patients with moderate-to-severe HS, 2 and 6 weeks after initiation of an anti-TNF-alpha treatment.

    E.2.2Secondary objectives of the trial
    Furthermore clinical parameters should be evaluated after 2 and 6 weeks of treatment with adalimumab e.g. reduction of pain, reduction of itch, reduction of clinical parameters (clinical scores) and shroud be brought in connection with the clinical inflammatory pattern.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main inclusion criteria
    • Diagnosis of HS for minimum of six months
    • Disease state diagnosed to be active and moderate to severe HS, requiring systemic therapy
    • No severe or otherwise clinically significant abnormalities found within the patient’s medical/medication history, nor during physical examination
    • Minimum of one previously failed or insufficiently responded to systemic therapy for HS
    • Women of childbearing age who are sexually active must use a highly effective form of contraception (Pearl Index < 1%) for the duration of the study
    • Negative test for tuberculosis (TB) according to local guidelines, obtained no more than three months prior to screening
    • Written informed consent and availability of any locally required authorization obtained from the subject, prior to performing any protocol-related procedures
    • Patients must be able and willing to comply with the requirements of this protocol
    • Age 18–65 years
    E.4Principal exclusion criteria
    Main exclusion criteria
    • Previous use of Adalimumab (Humira®) or any other TNF-α inhibitors

    Exclusion criteria related to IMP
    • According to SmPC
    • According to approval status of EMA
    • According to approval status of Adalimumab for treatement of HS in Germany
    • Known hypersensitivity to any component of the IMP

    Exclusion criteria related to general health
    • Active dermatologic conditions that may confound the diagnosis of HS or would interfere with the assessment of treatment (e.g., atopic dermatitis, seborrhoic dermatitis, ichthyosis, psoriasis vulgaris, folliculitis)
    • History of a clinically significant infection four weeks prior to baseline visit, which, in the opinion of the investigator, may compromise the safety of the subject
    • History of chronic alcohol/drug abuse within the last 12 months before screening
    • Pregnant or breastfeeding women
    • Severe kidney insufficiency (GFR < 30 ml/min)
    • Any severe diseases that may, in the opinion of the investigator, interfere or worsen the hidradenitis suppurativa or result in safety concerns for patients being treated with an anti-TNF-alpha Inhibitor
    • History or presence of human immunodeficiency virus (HIV), and/or hepatitis B (HBV) or C virus (HCV) infections
    • History of active tuberculosis (TB), or untreated or inadequately treated latent TB (LTBI). Subjects must have a negative QuantiFERON, T-SPOT, or purified protein derivative (PPD) test, performed less than three months before the screening visit.
    • Any active medication which suppresses the immune system
    • History, current signs, symptoms, or diagnosis of a demyelinating disorder
    • History of or current Class III or IV congestive heart failure, as defined by the New York Heart Association,
    • History or current signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
    • Current malignancy or history of any malignancy, except for adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ; no more than a total of three lifetime basal cell or squamous cell carcinomas permitted
    • Concurrent enrolment in another clinical trial, in which the subject is receiving an investigational product
    • Any major surgery in the last four weeks, that in the opinion of investigator, study related procedures or treatment with an anti-TNF-alpha inhibitor is contraindicated.
    • Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease, including pleural effusions or ascites, which, in the opinion of the investigator pose an unacceptable safety risk
    • History of latex allergy
    E.5 End points
    E.5.1Primary end point(s)
    • To analyze the pattern of inflammatory cytokines in patients with moderate-to-severe HS before treatment with a TNF-alpha antagonist.

    • To evaluate changes (quantitative) in the pattern of inflammatory cytokine expression in patients with moderate-to-severe HS, 2 and 6 weeks after initiation of an anti-TNF-alpha treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 2 and 6 weeks go treatment with the TNF-alpha Inhibitor Adalimumab.
    E.5.2Secondary end point(s)
    • Evaluation of changes in HS severity, as assessed using the Hidradenitis Suppurativa Clinical Response Score (HiSCR), IHS4 Score (International Hidradenitis suppurativa 4), Modified sartorius score and HsPGA (Hidradenitis suppurativa physicians clinical assessment) at week 0, 2- and 6 will be determined.

    • Evaluation of subjective changes in pain on a VAS during 2- and 6-week courses of treatment with a TNF-alpha antagonist.

    • Evaluation of the subjects’ subjective changes in itching on a VAS during 2- and 6-week courses of treatment with a TNF-alpha antagonist.

    • Evaluation of the change in patients’ quality of life using the DLQI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 2 and 6 weeks go treatment with the TNF-alpha Inhibitor Adalimumab.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Main focus of that trail is to describe the inflammatory pattern of a common chronic skin disease and the change of the pattern during a specific anti-TNF-alpha therapy with Adalimumab. Not much is known about the pattern of pro inflammatory cytokines and the its change.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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
    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 months6
    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: 15
    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 state15
    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 6 week course of Adalimumab patients can be further treated with HUMIRA. This decision will be made after EOT/EOS after 6 weeks. Decision for further treatment depend of the treatment success as well a safety issues. Adalimumab is approved for patients with moderate-to-severe forms of Hidradenitis suppurativa and can therefor prescribed regularly.
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-03
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