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    Summary
    EudraCT Number:2016-001566-28
    Sponsor's Protocol Code Number:UCDCRC/16/002
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-07
    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 ConcernedIreland - HPRA
    A.2EudraCT number2016-001566-28
    A.3Full title of the trial
    Usage of Omics Technology for Identification of Critical Mediators and Pathways in Patients with Hidradenitis Suppurativa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Identifying mediators in patients with hidradenitis supportive
    A.3.2Name or abbreviated title of the trial where available
    DERMMARK
    A.4.1Sponsor's protocol code numberUCDCRC/16/002
    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 College Dublin
    B.1.3.4CountryIreland
    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 supportScience Foundation Ireland
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College Dublin
    B.5.2Functional name of contact pointRabia Hussain
    B.5.3 Address:
    B.5.3.1Street AddressCatherine McAuley Centre, Mater Hospital
    B.5.3.2Town/ cityNelson Street
    B.5.3.3Post codeDublin 7
    B.5.3.4CountryIreland
    B.5.4Telephone number0035317164593
    B.5.6E-mailrabia.hussain@ucd.ie
    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
    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 nameHUMIRA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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
    E.1.1.1Medical condition in easily understood language
    Rare skin disease
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020041
    E.1.2Term Hidradenitis suppurativa
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    TTo stratify patients with moderate to severe HS into those who respond to treatment (responders) with Humira and those who fail to respond to treatment with Humira (non-responders). The cytokine and chemokine profiles in lesional and perilesional microdialysate will be compared between responders and non-responders.
    E.2.2Secondary objectives of the trial
    To discover novel biomarkers that can be used to predict response to Humira treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be over 18 years of age.
    2. Diagnosis of Hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
    3. Diagnosis of HS Hurley stage II or III made by a consultant dermatologist.
    4. Capable of giving informed consent.
    5. Naïve to previous anti-TNF treatment
    6. Patients must have an AN (total count of abcesses and inflammatory nodules) count of 3 or greater and a draining fistula count ≤ 20
    7. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. Women of child bearing potential should use effective birth control methods throughout the trial and for at least 5 months afterwards.
    8. Subject must have stable HS for at least 7 days prior to screening visit and at Baseline visit.
    9. Subjects have clinically acceptable laboratory and ECG/CXR findings at screening visit.
    10. Patients should have an adequate indication for receiving Humira treatment fro hidradenitis suppurativa as per current SmPC.
    11. Clinically acceptable laboratory findings imply that blood results are within the expected normal reference range for the laboratories in both St Vincent’s Hospital and the Mater Hospital.
    12. ECGs should show no abnormalities /no new changes compared with previous ECGs
    13. CXR findings should be non- significant/ stable compared with previous CXRs.
    E.4Principal exclusion criteria
    1. Allergy/sensitivity to study medications or their ingredients
    2. Previously treated with Humira or another anti-TNF therapy
    3. Pregnancy/breast feeding
    4. <18 years of age
    5. Major Psychiatric illness
    6. Contraindication to anti-TNF treatment
    7. History of moderate to severe congestive heart failure (New York Health
    Association [NYHA] class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator would put the subject at risk by participation in the protocol;
    8. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease;
    9. History of invasive infection (e.g., listeriosis, histoplasmosis), human immunodeficiency virus (HIV);
    10. Subject has an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study
    11. Hepatitis B: HBsAg positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBcAb/HBsAb positive subjects
    12. Chronic recurring infections or active TB;
    13. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
    14. Subjects who have participated in another study and received any other investigational agent within 1 month
    15. Subjects unable to provide written informed consent
    16. Subjects who have any other significant disease or disorder (including uncontrolled diabetes, unstable ischemic heart disease, moderate to severe congestive heart failure, recent cerebrovascular accident) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study.
    17. Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
    18. Prior or concurrent malignancy
    19. AST or ALT ≥ 3 x ULN
    20. Creatinine clearance (CrCl) < 60 mL/min measured by 24-hour urine collection or estimated by the Cockcroft and Gault formula
    21. Subjects have clinically significant ECG findings as judged by the investigator
    22. Scheduled for procedures requiring general anaesthesia during the study
    23. Latex allergy
    E.5 End points
    E.5.1Primary end point(s)
    Inflammatory profiles of responders vs non responders in lesional and peri-lesional skin biopsies. Inflammatory mediator profiles of responders vs non responders in lesional and perilesional microdialysate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    1. Proportion of patients achieving clinical response after 12 weeks treatment with Humira, using HiSCR (Time line: Baseline to week 12). This will stratify patients into non responders and responders for secondary analysis
    2. Change from baseline in AN count
    3. Change from baseline in Dermatologic Life Quality Index (DLQI)
    4. Change from baseline in pain VAS
    5. Novel biomarkers that can be used to predict response to Humira treatment.

    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    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 No
    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
    Identification of Critical Mediators and Pathways in Patients with Hidradenitis Suppurativa
    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 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 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
    The end-of-trial is the date of the last telephone follow-up of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 32
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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
    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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-05-13
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