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    Summary
    EudraCT Number:2018-001021-10
    Sponsor's Protocol Code Number:SAHL1011
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-17
    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 ConcernedSweden - MPA
    A.2EudraCT number2018-001021-10
    A.3Full title of the trial
    Brodalumab in a randomised, open, phase IV study evaluating clinical efficacy in psoriasis patients switching from TNF-alpha inhibitor treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical study with brodalumab for patients suffering from psoriasis and not benefitting the TNF-alpha treatment.
    A.4.1Sponsor's protocol code numberSAHL1011
    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 SponsorSahlgrenska University Hospital
    B.1.3.4CountrySweden
    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 Ab
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska University Hospital
    B.5.2Functional name of contact pointAmra Osmancevic
    B.5.3 Address:
    B.5.3.1Street AddressGröna Stråket 16
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code41345
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 (0)31 34 29682
    B.5.6E-mailamra.osmancevic@vgregion.se
    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 AuthorisationSweden
    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 Injection
    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 namebrodalumab
    D.3.9.4EV Substance CodeSUB180076
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number210
    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
    Moderate to severe plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    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 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate efficacy of brodalumab treatment 210 mg every
    two weeks (Q2W) in subjects with moderate to severe plaque psoriasis in whom the
    treatment response to TNF-alpha inhibitors (standard of care) is insufficient, measured as
    proportion of subjects achieving PASI <3 after 12 weeks of treatment (brodalumab arm vs
    TNF/brodalumab arm).
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the clinical treatment effect of brodalumab treatment 210 mg Q2W in subjects with moderate to severe plaque psoriasis who are insufficient responders to TNF-alpha inhibitor treatment (standard of care) and the subjects’ quality of life, assessed by PASI, DLQI, Montgomery-Åsberg Depression Rating Scale (MADRS), Hospital Anxiety and Depression Scale (HADS), Patient Global Assessment (PaGA) and Visual Analogue Scale (VAS) (pruritus / itch).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed and dated informed consent has been obtained
    2) Men or women ≥18 years of age at the time of screening
    3) Subjects with moderate to severe plaque psoriasis diagnosed ≥6 months before
    randomisation
    4) Subjects on TNF-alpha inhibitors, either Adalimumab or Etanercept, for at least 24 weeks (Etanercept) or 16 weeks (Adalimumab), with at time of inclusion an absolute PASI score >7 or PASI 3-7 + DLQI >5 + BSA >3.
    5) Subject has no known history of active tuberculosis
    6) A female subject of childbearing potential* is eligible to participate if she is not pregnant.
    *Female subjects are considered of childbearing potential unless they have undergone
    hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or have been post-menopausal for at least one year prior to first visit.
    7) Using effective contraceptive measures:
    Women of childbearing potential should use an effective method of contraception during
    treatment and for at least 12 weeks after treatment.
    Male subject with a female partner of childbearing potential who is willing to use effective contraceptive methods*. Male subjects should not donate sperm for at least 12 weeks following last dose of investigational product.
    *Effective contraceptive methods as required by local regulation or practice for at least 12 weeks following last dose of investigational product.
    8) Subject and/or subject’s designee is/are capable of administering subcutaneous
    injections
    E.4Principal exclusion criteria
    1) Subject has an active infection as follows: any active infection for which systemic anti-infectives were used within 28 days prior to first dose of IMP, a serious infection defined
    as requiring hospitalisation or intravenous anti-infectives within 8 weeks prior to the first
    dose of IMP, recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
    2) Subject has any systemic disease (e.g. renal failure, heart failure, hypertension, liver
    disease, diabetes, anaemia) considered by the investigator to be clinically significant and
    uncontrolled.
    3) Subjects with active or known history of inflammatory bowel disease (IBD) including Crohn’s disease.
    4) Previous treatment with IL-17 inhibitors (Secukinumab and/or Ixekizumab)
    5) Planned surgery, which in the opinion of the investigator would influence planned
    treatment with IMP.
    6) Subjects with a history of suicidal behaviour.
    7) Known or suspected hypersensitivity to any components of the IMP.
    8) Current participation in any other interventional clinical study, ending another
    interventional clinical study less than 4 weeks prior to screening visit, or receiving other
    investigational agents (based on interview of the subject).
    9) Subjects who have received treatment with any non-marketed drug substance (i.e. an
    agent which has not yet been made available for clinical use following registration) within
    the last 4 weeks prior to screening visit.
    10) Previously enrolled in this clinical study.
    11) In the opinion of the (sub)investigator, the subject is unlikely to comply with the clinical study protocol (e.g. due to alcoholism, drug addiction or psychotic state).
    12) Subjects in close affiliation with the study personnel (e.g. immediate family member or subordinate), subjects who are a member of the clinical study personnel, or an employee of the sponsor or a CRO involved in the study.
    13) Subjects under guardianship, hospitalised in a public or private institution, for a reason other than research, or subjects deprived of freedom.
    14) Female subjects who are pregnant or breastfeeding.
    15) Subject has any concurrent medical condition that, in the opinion of the investigator,
    could cause this study to be detrimental to the subject.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving PASI <3 after 12 weeks of treatment (brodalumab
    arm vs TNF/brodalumab arm)
    E.5.1.1Timepoint(s) of evaluation of this end point
    PASI at weeks 0,4,8 and 12 for brodalumab arm and at weeks 0,8,12,16,20 and 24 for TNF/brodalumab arm
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
     -The proportion of subjects with ≥75%, ≥90%, 100% improvements in PASI score
    (PASI 75, PASI 90, PASI 100) at week 12 (brodalumab arm) and weeks 12 and 24
    (TNF/brodalumab arm)
     -Change from baseline in PASI score at week 12 (brodalumab arm) and weeks 12 and
    24 (TNF/brodalumab arm)
     -PASI improvement (%) from baseline at week 12 (brodalumab arm) and weeks 12
    and 24 (TNF/brodalumab arm)
     -Change from baseline in DLQI total score at week 12 (brodalumab arm) and
    weeks 12 and 24 (TNF/brodalumab arm)
     -Proportion of subjects with DLQI total score of 0 or 1 at week 12 (brodalumab arm)
    and weeks 12 and 24 (TNF/brodalumab arm)
     -Change in MADRS at week 12 (brodalumab arm) and weeks 12 and 24
    (TNF/brodalumab arm)
     -Change in HADS at week 12 (brodalumab arm) and weeks 12 and 24
    (TNF/brodalumab arm)
     -Change from baseline in PaGA score at week 12 (brodalumab arm) and weeks 12
    and 24 (TNF/brodalumab arm)
     -PaGA improvement (%) from baseline at week 12 (brodalumab arm) and weeks 12
    and 24 (TNF/brodalumab arm)
     -Change in VAS pruritus / itch at week 12 (brodalumab arm) and weeks 12 and 24
    (TNF/brodalumab arm)

    Exploratory Efficacy Endpoints
     -Change from baseline (day 0) in serum pro-inflammatory psoriasis cytokines (to be
    detailed later) at week 12 (brodalumab arm) and change from baseline (day 0)
    compared to weeks 12 and 24 (TNF/brodalumab arm)
     -Change from baseline (day 0) in s-calcium, serum vitamin D levels (free and bound
    25OHD), and parathyroid hormone (PTH) at week 12 (brodalumab arm) and change
    from baseline (day 0) compared to weeks 12 and 24 (TNF/brodalumab arm)
     -Changes from baseline (day 0) in gut microbiome and inflammatory markers in serum
    and stool samples (serum and faecal calprotectin as well as serum serotonin) at week
    12 (brodalumab arm) and change from baseline (day 0) compared to weeks 12 and
    24 (TNF/brodalumab arm)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -PASI, DLQI, MADRS, HADS, PaGA and VAS at weeks 0,4,8 and 12 for brodalumab arm and at weeks 0,8,12,16,20 and 24 for TNF/brodalumab arm.
    -s-cytokines, s-calcium, s-vitamin d, parathyroid hormone (PTH), s- and f-calpro and s-serotonin at weeks 0 and 12 for brodalumab arm and at weeks 0,12 and 24 for TNF/brodalumab arm.
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    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 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 concerned10
    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 months2
    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: 75
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 15
    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 state90
    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)
    Normal standard of care
    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 Decision2018-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-18
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