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    Summary
    EudraCT Number:2017-003697-14
    Sponsor's Protocol Code Number:PsoPET2
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-28
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-003697-14
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, trial to evaluate the efficacy
    of brodalumab monotherapy on vascular and systemic inflammation by 18F-FDG-PET/CT in subjects with moderate-to-severe plaque-type psoriasis who are candidates for systemic therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of brodalumab compared to placebo on vascular inflammation in moderate-to-severe psoriasis
    Effekten af brodalumab sammenlignet med placebo på inflammation i hovedpulsåren hos patienter med moderat til svær psoriasis
    A.4.1Sponsor's protocol code numberPsoPET2
    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 SponsorAarhus University Hospital
    B.1.3.4CountryDenmark
    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 supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointSecretary M. Larsen
    B.5.3 Address:
    B.5.3.1Street AddressPP Ørums Gade 11
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post codeDK-8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number457846 1856
    B.5.6E-mailannebreg@rm.dk
    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 Kyntheum
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Solution for injection in pre-filled injector
    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 INNBRODALUMAB
    D.3.9.3Other descriptive nameKyntheum
    D.3.9.4EV Substance CodeSUB180076
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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) 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-to-severe psoriasis. Vascular and systemic (splenic) inflammation in psoriasis subjects.
    E.1.1.1Medical condition in easily understood language
    Psoriasis and inflammation in the vascular wall in patients with psoriasis. Systemic inflammation in psoriasis patients.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003605
    E.1.2Term Atherosclerosis of aorta
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041634
    E.1.2Term Spleen disorder NOS
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the change in aortic wall inflammation from baseline to week 16 in brodalumab treated psoriasis subjects compared to placebo.
    E.2.2Secondary objectives of the trial
    To assess the change in splenic inflammation from baseline to week 16 in brodalumab treated psoriasis subjects compared to placebo.
    To assess the change in aortic wall subsegment inflammation from baseline to week 16 in brodalumab treated psoriasis subjects compared to placebo.
    To assess whether changes in skin inflammation is associated with changes in aortic wall inflammation and/or changes in splenic inflammation.
    Additional:
    To assess the change in subcutaneous adipose tissue inflammation and whether this change is associated with changes in skin inflammation.
    To assess the change in soluble inflammatory biomarkers.
    To assess whether the change in aortic wall inflammation and/or splenic inflammation is associated with psoriasis-specific genotypes.
    To assess the change in gene expression and cytokine expression in paired lesional and non-lesional psoriatic skin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from the subject prior to performing any protocol-related procedures.
    2. Age 40 and above.
    3. Diagnosis of chronic plaque psoriasis confirmed by a dermatologist
    4. Psoriasis area severity index (PASI) ≥ 10
    E.4Principal exclusion criteria
    1. Non-Danish speaking
    2. History of inflammatory bowel disease, arthritis (not including psoriatic arthritis), systemic lupus erythematosus, and active inflammatory skin diseases.
    3. A history of malignancies within the past five years (excluding localized non-melanoma skin cancer).
    4. Topical corticosteroid treatment (class III or stronger) and/or ultraviolet type B phototherapy within 2 weeks prior to randomization
    5. Treatment with psoralen plus ultraviolet type A photochemotherapy, methotrexate, cyclosporine, acitretin, or fumaric acid esters within 4 weeks prior to randomization.
    6. Treatment with adalimumab, etanercept, infliximab, cosentyx, or ixekizumab within 12 weeks, ustekinumab within 24 weeks, or other immunosuppressive or anti-inflammatory agents within 5 half-lives of the active substance prior to the FDG-PET/CT, respectively.
    7. Scheduled surgery during the trial period (expect minor minimally invasive procedures).
    8. Systemic infection or fever within 7 days prior to FDG-PET/CT.
    9. Severe obesity (> 150 kg due to a PET/CT scanner limitation).
    10. Presence of uncontrolled diabetes mellitus (HbA1c > 75 mmol/mol and/or blood sugar > 11.1 mmol/l and/or clinical judgment).
    11. History of coagulation defects (clinical judgment).
    12. Active or latent tuberculosis requiring treatment.
    13. Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.
    14. History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject’s verbal report.
    15. No history of varicella zoster infection and negative varicella antibody test (until varicella vaccination is completed).
    16. History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator.
    17. History of intravenous drug use.
    18. History of attempted suicide or is at significant risk of suicide.
    19. Major surgery within the past 3 months.
    20. Pregnancy or lactation (Women of childbearing potential must use a highly effective* form of birth control (confirmed by the investigator) throughout the trial and until 12 weeks after discontinuation of treatment with brodalumab.
    21. Claustrophobia.
    22. Reduced renal function (serum creatinine > 200 ╬╝mol/L or cr-EDTA clearance < 30 ml/min)
    23. Any disorder, including but not limited to, cardiovascular, lung, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, psychiatric, or major physical impairment that is not stable, in the opinion of the investigator, and could:
    o Affect the safety of the subject throughout the trial.
    o Influence the findings of the trial or their interpretations.
    o Impede the subject’s ability to complete the entire duration of trial.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the average of maximum Target-to-background (TBR) values (MeanTBRmax) of the entire aorta from baseline to week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 0 and week 16
    E.5.2Secondary end point(s)
    • Change in the spleen-to-liver ratio (SLR) based on splenic and liver mean standardised uptake values (SUVmean)

    • Change in the average of maximum TBR values (MeanTBRmax) of the ascending, aortic arch, descending, suprarenal, and infrarenal aorta from baseline to week 16

    • Association between change in PASI and change in aortic wall MeanTBRmax

    • Association between change in PASI and change in SLR

    Additional secondary endpoints:

    • Change in the average of maximum SUV values (MeanSUVmax) of the abdomial subcutaneous adipose tissue from baseline to week 16
    • Association between change in PASI and change in subcutaneous adipose tissue MeanSUVmax.

    • Changes in acute phase proteins from baseline to week 16


    • Correlation between changes in both aortic meanTBRmax and SLR and prescence of HLA-B*08, HLA-C*06:02, HLA-B*27, HLA-B*38 and HLA-B*39

    • Changes in gene expression and cytokine expression in skin samples from baseline to week 16
    • Correlation with changes in mean aortic TBRmax and SLR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 0 and week 16
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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.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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 years1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state50
    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)
    In order to ensure appropriate treatment of the subjects after they have completed the trial, subjects will be treated at the investigator’s discretion or referred to other physicians according to clinical practice and national treatment guidelines. This also applies to subjects that dropout or terminates the study before completing all visits.
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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