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    Summary
    EudraCT Number:2020-002759-39
    Sponsor's Protocol Code Number:20190194
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002759-39
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria
    Studio di dose-ranging di fase IIb, multicentrico, randomizzato, in doppio cieco, controllato con placebo, volto a valutare l’efficacia e la sicurezza di tezepelumab nel trattamento dell’orticaria spontanea cronica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria
    Efficacia e sicurezza di tezepelumab nel trattamento dell'orticaria spontanea cronica
    A.3.2Name or abbreviated title of the trial where available
    INCEPTION
    INCEPTION
    A.4.1Sponsor's protocol code number20190194
    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 SponsorAMGEN INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia E. Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number0039026241121
    B.5.6E-mailmedicalinformationitaly@amgen.com
    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 No
    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 nameTezepelumab
    D.3.2Product code [AMG 157]
    D.3.4Pharmaceutical form 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 INNtezepelumab
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeAMG 157
    D.3.9.4EV Substance CodeSUB179650
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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 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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 XOLAIR - 150MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) - 1.0 ML 1 SIRINGA PRERIEMPITA
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD
    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 nameOmalizumab
    D.3.2Product code [Omalizumab]
    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 INNOMALIZUMAB
    D.3.9.1CAS number 242138-07-4
    D.3.9.2Current sponsor codeOmalizumab
    D.3.9.4EV Substance CodeSUB12543MIG
    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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Chronic Spontaneous Urticaria
    Orticaria spontanea cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Spontaneous Urticaria
    Orticaria spontanea cronica
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072757
    E.1.2Term Chronic spontaneous urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7)
    Valutare l’effetto di tezepelumab sul miglioramento del punteggio Urticaria Activity Score over 7 days (UAS7)
    E.2.2Secondary objectives of the trial
    To evaluate the effect of tezepelumab on :
    - compared with placebo in CSU subjects using the UAS7
    - improvement in itch using the Itch Severity Scoreover 7 days (ISS7)
    - improvement in hives using the Hives Severity Score over 7 days (HSS7)
    - subjects achieving minimal residual disease using the UAS7
    - subjects achieving the minimal important difference (MID) on change from baseline in the UAS7
    - on complete resolution of itch using the ISS7
    - on subjects achieving the MID on change from baseline in the ISS7
    - on the complete resolution of hives using the HSS7
    - on subjects achieving the MID on change from baseline in the HSS7

    *Please refer to protocol for the full list
    Valutare l'effetto di tezepelumab:
    - rispetto al placebo in soggetti con CSU sulla base del punteggio UAS7
    - sul miglioramento del prurito utilizzando il punteggio Itch Severity Score over 7 days (ISS7)
    - sul miglioramento dell’orticaria utilizzando il punteggio Hives Severity Score over 7 days (HSS7)
    - sui soggetti che raggiungono uno stato di malattia minima residua in base al punteggio UAS7
    - sui soggetti che raggiungono una differenza minima importante (MID) nella variazione rispetto al basale del punteggio UAS7
    - sulla risoluzione completa del prurito utilizzando il punteggio ISS7
    - sui soggetti che raggiungono una MID nella variazione rispetto al basale del punteggio ISS7
    - sulla risoluzione completa dell’orticaria utilizzando il punteggio HSS7
    - sui soggetti che raggiungono una MID nella variazione rispetto al basale del punteggio HSS7

    * Fare riferimento al protocollo per la lista completa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject has been informed about study procedures and medications and has provided informed consent prior to initiation of any study specific activities/procedures
    - Subject is able to communicate with the investigator, and understands and complies with the requirements of the study
    - Age >= 18 to <= 80 years of age at screening
    - Chronic spontaneous urticaria diagnosis for >= 6 months at the time of screening visit 1
    - Diagnosis of CSU inadequately controlled by sgAH at enrollment, as defined by all of the following:
    -The presence of itch and hives for >= 6 consecutive weeks at any time prior to screening visit 2 despite current use of an approved dose of H1-antihistamine
    -Urticaria Activity Score over 7 days (UAS7) (range 0-42) >=16 and Hives Severity Score over 7 days (HSS7) (range 0-21) >= 8 during the 7 days prior to enrollment

    *Please refer to protocol for the full list
    - Il soggetto è stato informato sulle procedure dello studio e sui farmaci e ha fornito il consenso informato prima dell'inizio di qualsiasi attività/procedura specifica dello studio
    - Il soggetto è in grado di comunicare con lo sperimentatore e comprende e rispetta i requisiti dello studio
    - Età >= 18 a <= 80 anni allo screening
    - Diagnosi di orticaria cronica spontanea da >= 6 mesi al momento della visita di screening 1
    - Diagnosi di CSU inadeguatamente controllata da sgAH all'arruolamento, come definita da tutti i seguenti elementi:
    - La presenza di prurito e orticaria per >= 6 settimane consecutive in qualsiasi momento prima della visita 2 di screening, nonostante l'uso corrente di una dose approvata di antistaminico H1
    - Urticaria Activity Score over 7 days (UAS7) (range 0-42) >= 16 e Hives Severity Score over 7 days (HSS7) (range 0-21) >= 8 durante i 7
    giorni prima all'arruolamento

    *Fare riferimento al protocollo per la lista completa
    E.4Principal exclusion criteria
    Disease Related:
    - Urticaria is solely due to inducible urticaria
    - Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency)
    - Any other active skin disease associated with chronic itching that might influence,in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, dermatitis herpetiformis, senile pruritus, etc.)
    - History of a clinically significant infection within 28 days prior to day 1 that, in the opinion of the investigator or medical monitor, might compromise the safety of the subject in the study, interfere with evaluation of the investigational product, or reduce the subject's ability to participate in the study. Clinically significant infections are defined as either of the following:
    1) a systemic infection; or
    2) a serious skin infection requiring parenteral antibiotic, antiviral, or antifungal medication
    - Diagnosis of a helminth parasitic infection within 6 months prior to screening visit 1 that had not been treated with or had failed to respond to standard of care therapy

    *Please refer to protocol for the full list
    Correlati alla patologia:
    - L'orticaria è dovuta esclusivamente a orticaria indotta
    - Malattie dermatologiche attive (o condizioni) diverse dall'orticaria cronica, con ponfi da orticaria o sintomi di angioedema come vasculite orticarioide, eritema multiforme, mastocitosi cutanea (orticaria pigmentosa) e angioedema ereditario o acquisito (es: causato da mancanza di C1 inibitore)
    - Qualsiasi altra malattia attiva della pelle associata a prurito cronico che potrebbe influenzare, a giudizio dello sperimentatore, le valutazioni e i risultati dello studio (es. dermatite atopica, dermatite erpetiforme, prurito senile, ecc.)
    - Storia di infezione clinicamente significativa nei 28 giorni precedenti al giorno 1 che, secondo l'opinione dello sperimentatore o del monitor medico, potrebbe compromettere la sicurezza del soggetto nello studio, interferire con la valutazione del prodotto in sperimentazione o ridurre la capacità del soggetto di
    di partecipare allo studio. Le infezioni clinicamente significative sono definite come una delle seguenti:
    1) un'infezione sistemica; o
    2) un'infezione cutanea grave che richiede un antibiotico parenterale, un antivirale o un antimicotico
    - Diagnosi di un'infezione parassitaria da elminti nei 6 mesi precedenti la visita 1 di screening che non era stata trattata con o non aveva risposto alla terapia standard di cura

    * Fare riferimento al protocollo per la lista completa
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in UAS7 at week 16
    Valutare la variazione del punteggio UAS7 dal basale alla settimana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    settimana 16
    E.5.2Secondary end point(s)
    - Complete response in UAS7 defined as UAS7 = 0 at week 16
    - Change from baseline in ISS7 at week 16
    - Change from baseline in HSS7 score at week 16
    - UAS7 >= 6 at week 16
    - Change from baseline in UAS7 >= 10 at week 16
    - ISS7 = 0 at week 16
    - Change from baseline in ISS7 >= 5 at week 16
    - HSS7 = 0 at week 16
    - Change from baseline in sleep interference score at week 16
    - Change from baseline in the sleep interference and quality diary items at week 16
    - Change from baseline UCT score at week 16
    - Change from baseline in AAS7 at week 16
    - Cumulative weeks that subjects achieve AAS7 = 0 responses between baseline and week 16

    *Please refer to protocol for the full list
    - Risposta completa nel punteggio UAS7, definita come UAS7 = 0 alla settimana 16
    - Valutare la variazione del punteggio ISS7 dal basale alla settimana 16
    - Valutare la variazione del punteggio HSS7 dal basale alla settimana 16
    - UAS7 >= 6 alla settimana 16
    - Variazione del punteggio UAS7 >= 10 dal basale alla settimana 16
    - ISS7 = 0 alla settimana 16
    - Variazione del punteggio ISS7 >= 5 dal basale alla settimana 16
    - HSS7 = 0 alla settimana 16
    - Variazione del punteggio relativo all’interferenza con il sonno dal basale alla settimana 16
    - Variazione del punteggio delle voci del diario relative all’interferenza con il sonno e alla qualità del sonno dal basale alla settimana 16
    - Variazione del punteggio UCT dal basale alla settimana 16
    - Variazione del punteggio AAS7 dal basale alla settimana 16
    - Settimane cumulative in cui i soggetti raggiungono un punteggio AAS7 = 0 risposte tra il basale e la settimana 16

    *Fare riferimento al protocollo per la lista completa
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16
    settimana 16
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Japan
    Korea, Republic of
    United States
    France
    Germany
    Greece
    Italy
    Poland
    Spain
    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
    Completion of Follow UP
    Completamento del follow-up
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 249
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 No
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 87
    F.4.2.2In the whole clinical trial 270
    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)
    NA
    NA
    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 Decision2021-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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