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    Summary
    EudraCT Number:2019-004250-28
    Sponsor's Protocol Code Number:Psoriasi_Risa
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-004250-28
    A.3Full title of the trial
    EXPLORING THE EFFECTS OF IL-23 INHIBITION BY RISANKIZUMAB ON PSORIASIS AUTOIMMUNITY.
    ESPLORARE GLI EFFETTI DELL'INIBIZIONE IL-23 DI RISANKIZUMAB SULL'AUTOMUNITÀ DELLA PSORIASI.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EXPLORING THE EFFECTS OF IL-23 INHIBITION BY RISANKIZUMAB ON PSORIASIS AUTOIMMUNITY.
    ESPLORARE GLI EFFETTI DELL'INIBIZIONE IL-23 DI RISANKIZUMAB SULL'AUTOMUNITÀ DELLA PSORIASI.
    A.3.2Name or abbreviated title of the trial where available
    N.A.
    N.A
    A.4.1Sponsor's protocol code numberPsoriasi_Risa
    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 SponsorIRCCS ISTITUTO CLINICO HUMANITAS
    B.1.3.4CountryItaly
    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 supportAbbVie S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto Clinico Humanitas
    B.5.2Functional name of contact pointN.A.
    B.5.3 Address:
    B.5.3.1Street AddressVia Alessandro Manzoni, 56
    B.5.3.2Town/ cityRozzano (MI)
    B.5.3.3Post code20089
    B.5.3.4CountryItaly
    B.5.4Telephone number0282241
    B.5.6E-mailjessica.avagliano@humanitas.it
    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 Skyrizi
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRisankizumab
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNRisankizumab
    D.3.9.1CAS number 1612838-76-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameSkyrizi
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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
    Moderate to severe psoriasis
    Psoriasi a placche da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Moderate to severe psoriasis
    Psoriasi a placche da moderata a grave
    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
    Explore the effects of SKYRIZI on autoantigen-specific T-cell development and activation as measured by LL37 and ADAMTSL5 antigens by antigenic-specific proliferation assay at 28 weeks with respect to baseline
    Esplorare gli effetti di SKYRIZI sullo sviluppo e l'attivazione di cellule T specifici per autoantigene misurati dagli antigeni LL37 e ADAMTSL5 mediante saggio di proliferazione antigenico specifico a 28 settimane rispetto al basale.
    E.2.2Secondary objectives of the trial
    To assess and evaluate over 52 weeks of SKYRIZI treatment:
    • Psoriasis severity
    • Frequency and phenotype of autoreactive T-cells
    • Frequency of LL37 and ADAMTSL5 T-cells
    • Correlation between clinical response and frequency of autoreactive T-cells.
    Valutare oltre 52 settimane di trattamento SKYRIZI:
    • Gravità della psoriasi
    • Frequenza e fenotipo delle cellule T autoreattive
    • Frequenza delle cellule T LL37 e ADAMTSL5
    • Correlazione tra risposta clinica e frequenza delle cellule T autoreattive.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has provided informed consent
    2. Subject is ¿ 18 and ¿ 75 years of age at time of screening
    3. Subject has had stable moderate to severe plaque psoriasis for at least 6 months (e.g., no morphology changes or significant flares of disease activity in the opinion of the Investigator)
    4. Subject has involved body surface area (BSA) ¿ 10% and PASI ¿ 12 at baseline
    5. Subject candidates to risankizumab therapy according to local label
    6. Subject is able to complete study procedures, including self-assessments and self-injections
    7. Subjects who responded with T-lymphocytes proliferation to the psoriasis autoantigen LL37 or ADAMTSL5.
    8. Subject is male or a woman not of child-bearing potential, including:
    a. infertile patients due to surgical sterilization, congenital anomalies
    b. OR postmenopausal, defined as: a woman of at least 50 years of age with an intact uterus, not on hormone therapy, who has either:
    i. Cessation of menses for at least 1 year
    ii. OR At least 6 months of spontaneous amenorrhea with a follicle stimulating hormone level of >40 mIU/mL
    c. OR A woman of 55 years or older not on hormone therapy who has had at least 6 months of spontaneous amenorrhea
    d. OR A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
    9. Subject is a woman of child-bearing potential and:
    a. Must test negative for pregnancy prior to first dose in Study
    b. Must agree to either remain abstinent, if complete abstinence is their preferred and usual lifestyle, or remain in same-sex relationships, if part of their preferred and usual lifestyle, or without sexual relationships with males. Periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.
    c. OR Must use 2 effective methods of contraception for the entirety of the study. Abstinence or contraception must continue for 21 weeks following completion of investigational product administration
    i. Two effective methods of contraception (such as male or female condoms with spermicide, diaphragms with spermicide or cervical sponges) will be used. The patient may choose to use a double-barrier method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double-barrier method is not considered acceptable due to the high failure rate when these methods are combined.
    ii. Of note, 1 of the 2 methods of contraception may be a highly effective (less than 1% failure rate) method of contraception (such as, combination oral contraceptives, implanted contraceptives or intrauterine devices).
    1. Il soggetto ha fornito il consenso informato
    2. Il soggetto ha> = 18 e <= 75 anni al momento dello screening
    3. Il soggetto ha avuto una psoriasi a placche da moderata a grave stabile per almeno 6 mesi (ad esempio, nessuna modifica morfologica o flare significativi dell'attività della malattia secondo il parere dello sperimentatore)
    4. Il soggetto ha coinvolto la superficie corporea (BSA)> = 10% e PASI> = 12 al basale
    5. Sottoporre i candidati alla terapia con risankizumab secondo prescrizione
    6. Il soggetto è in grado di completare le procedure di studio, comprese autovalutazioni e autoiniezioni
    7. Subjects who responded with T-lymphocytes proliferation to the psoriasis autoantigen LL37 or ADAMTSL5.
    8. Subject is male or a woman not of child-bearing potential, including:
    a. infertile patients due to surgical sterilization, congenital anomalies
    b. OR postmenopausal, defined as: a woman of at least 50 years of age with an intact uterus, not on hormone therapy, who has either:
    i. Cessation of menses for at least 1 year
    ii. OR At least 6 months of spontaneous amenorrhea with a follicle stimulating hormone level of >40 mIU/mL
    c. OR A woman of 55 years or older not on hormone therapy who has had at least 6 months of spontaneous amenorrhea
    d. OR A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
    9. Subject is a woman of child-bearing potential and:
    a. Must test negative for pregnancy prior to first dose in Study
    b. Must agree to either remain abstinent, if complete abstinence is their preferred and usual lifestyle, or remain in same-sex relationships, if part of their preferred and usual lifestyle, or without sexual relationships with males. Periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.
    c. OR Must use 2 effective methods of contraception for the entirety of the study. Abstinence or contraception must continue for 21 weeks following completion of investigational product administration
    i. Two effective methods of contraception (such as male or female condoms with spermicide, diaphragms with spermicide or cervical sponges) will be used. The patient may choose to use a double-barrier method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double-barrier method is not considered acceptable due to the high failure rate when these methods are combined.
    ii. Of note, 1 of the 2 methods of contraception may be a highly effective (less than 1% failure rate) method of contraception (such as, combination oral contraceptives, implanted contraceptives or intrauterine devices).
    E.4Principal exclusion criteria
    Skin disease related:
    1. Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
    Other medical conditions:
    2. Subject has a planned surgical intervention during the duration of the study
    3. Subject has a known history of human immunodeficiency virus
    4. Hepatitis B surface antigen or Hepatitis C antibody positivity at screening
    5. Patient is hepatitis B core antibody positive (HBcAb +) but HbsAg and HBsAb negative
    6. Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease, renal failure, liver disease, or hypertension
    7. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
    8. Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma
    9. Subject has any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
    10. Has active TB or orther serious infection
    11. Has received, or is expected to receive, any live virus or bacterial vaccinatrion within 4 weeks before the first administration of study intervention
    Relativo alle malattie della pelle:
    1. Soggetto con diagnosi di psoriasi eritrodermica, psoriasi pustolosa, psoriasi guttata, psoriasi indotta da farmaci o altre condizioni della pelle al momento della visita di screening (ad esempio eczema) che interferirebbero con le valutazioni dell'effetto del prodotto sperimentale sulla psoriasi
    Altre condizioni mediche:
    2. Il soggetto ha programmato un intervento chirurgico durante la durata dello studio
    3. Il soggetto ha una storia nota di virus dell'immunodeficienza umana
    4. Antigene di superficie dell'epatite B o positività dell'anticorpo dell'epatite C allo screening
    5. Il paziente è positivo all'anticorpo anti-epatite B (HBcAb +) ma HbsAg e HBsAb negativi
    6. Il soggetto ha patologie sistemiche incontrollate, clinicamente significative come diabete mellito, malattie cardiovascolari, insufficienza renale, epatopatia o ipertensione
    7. Il soggetto presenta tumore, inclusa evidenza di carcinoma o melanoma cutaneo a cellule basali o squamose
    8. Il soggetto ha una storia di tumore entro 5 anni TRANNE trattato e considerato carcinoma cutaneo squamoso o basocellulare cutaneo curato, carcinoma cervicale in situ o carcinoma del dotto ammario in situ
    9. Il soggetto ha qualsiasi condizione medica concorrente che, secondo il parere dello sperimentatore, potrebbe rendere questo studio dannoso per il soggetto
    10. Ha una tubercolosi attiva o altre infezioni gravi
    11. Ha ricevuto, o si prevede che riceverà, qualsiasi virus vivo o vaccinazione batterica entro 4 settimane prima della prima somministrazione dell'intervento di studio
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of activated autoantigen-specific T-cells as measured by LL37 and ADAMTSL5 antigens by antigenic-specific proliferation assay at 28 weeks with respect to baseline.
    Proporzione di cellule T specifiche per autoantigene attivate misurate dagli antigeni LL37 e ADAMTSL5 mediante saggio di proliferazione antigenico specifico a 28 settimane rispetto al basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 weeks
    28 settimane
    E.5.2Secondary end point(s)
    At each timepoint the following will be described:
    • Change from baseline of PASI, BSA, IGA score (psoriasis severity indexes) – (0/4/16/28/40/52weeks)
    • Frequency and phenotype of autoreactive T cells by proliferation assay and flow cytometry – (0/16/28/52weeks)
    • Frequency of T-cells directed against LL37 and ADAMTSL5 by tetramers staining - (0/16/28/52weeks)
    • Correlation between the clinical response and the frequency of autoreactive T-cells - (0/16/28/52weeks)
    Ad ogni punto temporale verrà descritto quanto segue:
    • Variazione rispetto al basale del punteggio PASI, BSA, IGA (indici di gravità della psoriasi) - (0/4/16/28/40/52 settimane)
    • Frequenza e fenotipo delle cellule T autoreattive mediante saggio di proliferazione e citometria a flusso - (0/16/28/52 settimane)
    • Frequenza delle cellule T dirette contro LL37 e ADAMTSL5 mediante colorazione dei tetrameri - (0/16/28/52 settimane)
    • Correlazione tra la risposta clinica e la frequenza delle cellule T autoreattive - (0/16/28/52 settimane)
    E.5.2.1Timepoint(s) of evaluation of this end point
    nd
    nd
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 concerned4
    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 Information not present in EudraCT
    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
    End of the study is the date of the last visit or last scheduled procedure for the last patient.
    Fine dello studio è la data dell'ultima visita o dell'ultima procedura programmata per l'ultimo paziente.
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    xxxxxxxxxxxxxxxxxxx
    xxxxxxxxxxxxxxxxxxx
    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 Decision2020-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-07-18
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