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    Summary
    EudraCT Number:2018-000097-30
    Sponsor's Protocol Code Number:2018-PSO-IL17R
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-28
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-000097-30
    A.3Full title of the trial
    Efficacy of brodalumab in patients with psoriasis with failure of other anti-IL-17 treatments
    Effekt af brodalumab hos patienter, som har haft svigt af anti-IL-17A-behandling
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of brodalumab in patients with psoriasis with failure of other anti-IL-17 treatments
    Effekt af brodalumab hos patienter, som har haft svigt af anti-IL-17A-behandling
    A.4.1Sponsor's protocol code number2018-PSO-IL17R
    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 SponsorHerlev and Gentofte 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 organisationHerlev and Gentofte Hospital
    B.5.2Functional name of contact pointDept of Dermatology and Allergy
    B.5.3 Address:
    B.5.3.1Street AddressKildegaardsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538673204
    B.5.5Fax number004538677615
    B.5.6E-maillone.skov.02@regionh.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 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 namebrodalumab
    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 INNBRODALUMAB
    D.3.9.1CAS number 1174395-19-7
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis
    Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    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 10050576
    E.1.2Term Psoriasis vulgaris
    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
    This study will evaluate brodalumab treatment in patients with moderate-to-severe psoriasis previously treated with anti-IL-17A with primary or secondary failure of treatment.

    1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 3 months.
    2. Percentage of patients achieving PASI90 after 3 months.
    Formålet med studiet er at undersøge om patienter med moderat-til-svær psoriasis med tidligere svigt af anti-IL-17A har effekt af behandling med brodalumab.

    • Undersøge andelen af patienter der opnår PASI75 eller absolut PASI≤2 efter 3 måneders behandling med brodalumab.
    • Undersøge andelen af patienter der opnår PASI90 efter 3 måneders behandling med brodalumab.
    E.2.2Secondary objectives of the trial
    1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 6 and 12 months respectively.
    2. Percentage of patients achieving PASI90 after 6 and 12 month respectively.
    3. Percentage of patients achieving PASI100 after 3, 6, and 12 months respectively.
    4. Changes in DLQI score after 3, 6, and 12 months treatment with brodalumab compared to DLQI score before treatment with brodlaumab.
    5. Changes in inflammatory cytokines in blood after treatment and at each evaluation point compared to before treatment.
    6. Changes in oxidative stress level after treatment and at each evaluation point compared to before treatment.
    • Undersøge andelen af patienter der opnår PASI75 eller absolut PASI≤2 efter 6 og 12 måneders behandling med brodalumab.
    • Undersøge andelen af patienter der opnår PASI90 efter 6 og 12 måneders behandling med brodalumab.
    • Undersøge andelen af patienter der opnår PASI100 efter 3, 6 og 12 måneders behandling med brodalumab.
    • Ændring i DLQI score efter 3, 6 og 12 måneders behandling med brodalumab i forhold til DLQI score inden behandling med brodalumab.
    • Ændring i inflammatoriske cytokiner i blodet efter behandling med brodalumab efter 4, 12, 26 og 52 uger i forhold til før behandlingen.
    • Ændring i oxidativt stress niveau efter behandling med brodalumab efter 4, 12, 26 og 52 uger i forhold til før behandlingen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients must be > 18
    • Have had moderate-to-severe plaque psoriasis (PASI>10) and a PASI≥6 at screening.
    • Be eligible to receive biological treatment
    • Have been treated with anti-IL-17A (ixekizumab and/or secukinumab) with treatment failure, defined as either:
    o Primary failure: <PASI50 after 3 months, or
    o Secondary failure: Initial response, but with subsequent loss of efficacy
    • Patients must have given their informed consent to the protocol and the clinical procedures
    • Be able to speak and understand Danish
    • No systemic or biological treatment for psoriasis in the last 4 weeks.
    • No concomitant methotrexate treatment
    1. Kvinder og mænd, som er mindst 18 år på screeningstidspunktet
    2. Have haft moderat-til-svær psoriasis (PASI >10) og på screeningstidspunktet have PASI≥6
    3. Være kandidater til biologisk behandling af deres psoriasis jf. medicinerrådets retningslinjer
    4. Være behandlet med anti-IL-17A (secukinumab og/eller ixekizumab) for deres psoriasis og have fejlet på denne behandling, defineret som:
    - Primær failure: <PASI50 efter 3 måneder, eller
    - Sekundær failure: initial respons, men efterfølgende tab af effekt
    5. Patienten skal være i stand til at kommunikere med forsøgslægen og opfylde de betingelser forsøget stiller samt afgive skriftligt samtykke, før forsøgsrelaterede procedurer kan påbegyndes.
    6. Ikke have modtaget systemisk og/eller biologisk behandling for psoriasis de sidste 4 uger.
    7. Der må ikke gives samtidig methotrexat
    E.4Principal exclusion criteria
    • Patients with clinically significant disorders
    • Patients with active TB/serious infections
    • Any psychiatric condition which in the Investigators opinion would preclude the patient from adhering to the protocol or completing the study per protocol. Patients with previous endogene depression.
    • Pregnancy
    • Nursing
    • Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring or sterilization. Occlusive cap or condom with spermicidal cream is not considered safe contraception. Post-menopausal women (>12 months of amenorrhea) are allowed not to use contraception.
    • Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study
    • Allergy to brodalumab or any of the other ingredients in Kyntheum®
    • Active Crohn’s disease
    • Suicidal ideation and/or behavior
    1. Patienter med alvorlige kendte sygdomme som cancer (undtagen almindelig hudkræft og celleforandringer på livmoderhalsen)
    2. Patienter med kendt aktiv tuberkulose eller alvorlige infektiøse sygdomme
    3. Planlagt levende vaccine under forsøget eller 6 uger før baseline
    4. Gravide eller ammende kvinder
    5. Fertile kvinder skal anvende sikker prævention i hele forsøgsperioden og op til 16 uger efter behandlingsstop med brodalumab. Sikker prævention er p-piller, spiral, depotindsprøjtning af gestagen, hormonstav indsat under huden, hormonal vaginalring, depotplaster. Pessar eller kondom med sæddræbende creme anses ikke som sikker prævention. Sterilitet eller overgangsalder (> 12 måneder med amenoré) fritages for krav om prævention
    6. Patienter med aktiv Crohns sygdom
    7. Allergi over for brodalumab eller andre af de aktive stoffer i Kyntheum®
    8. Selvmordstanker og/eller -handlinger
    9. Enhver psykiatrisk lidelse som i investigatorernes vurdering vil udelukke patienten fra at vedholde protokollen eller udføre studiet efter protokollen
    10. Patienter med tidligere endogen depression
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 3 months.
    2. Percentage of patients achieving PASI90 after 3 months.
    • Andelen af patienter der opnår PASI75 eller absolut PASI≤2 efter 3 måneders behandling med brodalumab.
    • Andelen af patienter der opnår PASI90 efter 3 måneders behandling med brodalumab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1/7-20
    1/7-20
    E.5.2Secondary end point(s)
    Please see section E2
    Se venligst sektion E2
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/7-20
    1/7-20
    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 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 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
    LVLS
    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 months0
    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: 20
    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 state20
    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
    Ingen
    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 Decision2018-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-20
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