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    Summary
    EudraCT Number:2018-003642-17
    Sponsor's Protocol Code Number:OFM_DUPI_01
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-09-28
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-003642-17
    A.3Full title of the trial
    AN EXPLORATORY STUDY TO INVESTIGATE THE BIOAVAILABILITY AND PHARMACODYNAMICS OF DUPILUMAB IN DERMAL INTERSTITIAL FLUID OF ATOPIC DER-MATITIS PATIENTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An exploratory study to investigate the extent to which Dupilumab becomes available to the body as well as Its actions and effects in the liquid found between the skin cells of atopic dermatitis patients
    A.4.1Sponsor's protocol code numberOFM_DUPI_01
    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 SponsorMedical University Graz
    B.1.3.4CountryAustria
    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 supportSanofi
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Graz
    B.5.2Functional name of contact pointClinical Research Center
    B.5.3 Address:
    B.5.3.1Street AddressStiftingtalstraße 24
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number004331638572835
    B.5.6E-maileva.svehlikova@medunigraz.at
    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 Dupixent
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    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 nameDupixent
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdupilumab
    D.3.9.1CAS number 1190264-60-8
    D.3.9.3Other descriptive nameDUPILUMAB
    D.3.9.4EV Substance CodeSUB179171
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Atopic Dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic Dermatitis
    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 the pharmacodynamic effect of 16 week s.c. dupilumab treatment on inflammatory cytokine and chemokine levels in dermal interstitial fluid (ISF) of le-sional and non-lesional skin and blood of AD patients in correlation to its clinical treatment effect assessed using dermatologic scores listed below
    E.2.2Secondary objectives of the trial
     To investigate the effect of 16 week dupilumab treatment on eicosanoids in dermal ISF of atopic lesional and non-lesional skin in correlation to clinical treatment effect
     To investigate the effect of 16-week dupilumab treatment on local immune-cell pop-ulation in dermal ISF of atopic lesional and non-lesional skin in correlation to clinical treatment effect
     To investigate the effect of 16 week dupilumab treatment on metabolomic profile in blood and ISF from lesional and non-lesional atopic skin in correlation to clinical treatment effect.
     To investigate the changes in gene expression of relevant inflammatory biomarkers in the lesional skin biopsy specimen and ISF after 16 weeks of dupilumab treatment and to relate these changes to inflammatory biomarkers and immune cell pattern in ISF
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female atopic dermatitis patients 18 - 65 years of age (both inclusive) at the time of signing informed consent.
    2. Chronic atopic dermatitis diagnosed for at least 6 months before enrollment (according to American Academy of Dermatology Consensus Criteria [11] and to the UK Working Party's diagnostic criteria for atopic dermatitis [12])
    3. Moderate-to-severe atopic dermatitis (AD) classified as
    A) EASI (Eczema Area and Severity Index) [13] score >16 and
    B) IGA (Investigator’s global Assessment) ([14]) score ≥3 and
    C) not adequately controlled by topical medication(s).
    4. At least one suitable AD lesion that is well accessible for OFM investigation. (A single OFM probe requires a lesion of 35 mm length and 10 mm width; all probes can be placed in one lesion or each OFM probe in an individual lesion.)
    5. Subject is able to understand the study requirements, procedures, risks and benefits as outlined in the subject information sheet and informed consent form, is willing and able to comply with the specified requirements and procedures, and has signed the in-formed consent form before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suit-ability for the trial.
    6. If subject is female of child-bearing potential, she must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to Visit 2 and use an adequate and acceptable method of birth-control during the study.
    A female subject is considered of non-childbearing potential if one of the following is reported and documented on the medical history:
     postmenopausal with spontaneous amenorrhea for at least one (1) year, or
     surgical sterilization
    7. Subject is available for the entire study duration.
    E.4Principal exclusion criteria
    1. Pregnant and breast feeding women and women unwilling to use reliable contraception during the study, if of child-bearing potential and sexually active
    2. Significant allergies to humanized monoclonal antibodies, known hypersensitivity to dupilumab or any of its excipients
    3. Clinically significant multiple or severe drug allergies, severe drug-induced hypersensi-tivity reactions (including, but not limited to, erythema multiforme major, linear immuno-globulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis); ac-tive dermatoses in need of systemic treatment
    4. History of an ongoing, chronic or recurrent infectious disease, or known tuberculosis infection (both active and previous) as orally stated by the subject; History of Hepatitis B or C or HIV or positive screening serology test for Hepatitis B, C (acute infection) or HIV
    5. Alanine transaminase (ALT) >2x upper limit of normal (ULN)
    6. Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
    7. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice, or cirrhosis.
    NOTE: Stable chronic liver disease (including Gilbert’s syndrome, asymptomatic gall-stones) is acceptable if the participant otherwise meets entry criteria
    8. Asthma treated with other than inhalator medication (i.e. per oral or Intramuscular anti-asthmatic medication is not allowed)
    9. Known helminth infection; Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assess-ments have ruled out active infection
    10. Plans for administration of live vaccines during the study period or 4 weeks after last visit or within 12 weeks prior to Visit 2 (dosing).
    11. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 16 weeks or 5 half-lives (whichever is longer) or cell-depleting agents within 6 months before baseline, or until lymphocyte count returns to normal (whichever is longer) prior to dosing
    12. Treatment with dupilumab within 16 weeks prior to dosing
    13. Immunosuppressive/immunomodulating drugs (systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate) or phototherapy for AD within 4 weeks before Visit 2, or any condition that in the opinion of the investigator, is likely to require such treatments during the first 4 weeks of study treatment
    14. Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week be-fore screening
    15. Excessive sun exposure: e.g regular use (more than 2 visits per week) of a tanning booth/parlour within 4 weeks prior to first treatment and during the whole study treat-ment period
    16. Treatment with any other medications for AD that could interfere with efficacy out-comes or affect the evaluation for AD severity
    17. Uncontrolled systemic disease and ongoing infections (active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to visit 2 or superficial skin infections within 1 week pri-or to the visit 2)
    18. Known or suspected history of immunosuppression, including history of invasive oppor-tunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidiomycosis, pneumocystis, aspergillosis) despite infection resolution; or unusually frequent, recur-rent, or prolonged infections, per investigator judgement
    19. History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, or completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
    27. Any abnormalities found at physical examination or vital signs, unless deemed not clin-ically significant by the investigator.
    28. Clinically significant abnormal laboratory evaluation results, as deemed by the investi-gator
    29. Clinically significant abnormal 12-lead ECG at screening, as deemed by the investiga-tor
    30. Subject is actively enrolled in other clinical study
    31. Subjects prone to keloid or hypertrophic scar formation or any wound healing disorder
    32. Tattoos, or broken skin (other than AD damaged skin) at the insertion areas
    33. Needle phobia
    E.5 End points
    E.5.1Primary end point(s)
    Cytokines and chemokines in blood and ISF-samples from lesional and non-lesional skin (derived using OFM), i.e IL-4, IL-10, IL-13, IL-17A, IL-22, IL-23, CCL22, CCL20, CXCL1, CXCL10 prior to and after 16-week dupilumab treatment in correlation to clinical treatment effect assessed using clinical scores (SCORAD, EASI, IGA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Prior to and after 16 weeks of Dupilumab treatment (Visits 2 and 10)
    E.5.2Secondary end point(s)
     Eicosanoid concentrations (TXB2, PGE2, PGD2, PGF2α, LTB4, 15-HETE, 12-HETE, 5-HETE, 12-HEPE, 13-HODE, 17-HDHA) in ISF from lesional and non-lesional skin and blood samples prior to and after 16-week dupilumab treatment in correlation to clinical treatment effect assessed using clinical scores (SCORAD, EASI, IGA)
     Immune cells in ISF samples of lesional and non-lesional skin (e.g. granulocytes, monocytes, lymphocytes, CD4-, CD8-Tcells, Th17-like Tregs, Th-1,-2,-17 T cells, mast-cells, macrophages) prior to and after 16-week dupilumab treatment in corre-lation to clinical treatment effect assessed using clinical scores (SCORAD, EASI, IGA)
     Metabolomic profile in blood and ISF from lesional and non-lesional skin prior to and after 16-week dupilumab treatment in correlation to clinical treatment effect as-sessed using clinical scores (SCORAD, EASI, IGA)
     Gene expression of proinflammatory biomarkers from lesional skin biopsy specimen and ISF prior to and after 16-week dupilumab treatment in correlation to clinical treatment ef-fect assessed using clinical scores (SCORAD, EASI, IGA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Prior to and after 16 weeks of Dupilumab treatment (Visits 2 and 10)
    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 Yes
    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
    Bioavailability
    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.8.3 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
    LPLV
    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 months6
    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: 8
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 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 state8
    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 Decision2018-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-28
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