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    Summary
    EudraCT Number:2020-002759-39
    Sponsor's Protocol Code Number:20190194
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-03
    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 ConcernedFrance - ANSM
    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
    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
    A.3.2Name or abbreviated title of the trial where available
    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 SAS
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street Address18 - 20 Quai du point du jour
    B.5.3.2Town/ cityBoulogne Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number0969363 363
    B.5.6E-mailfr-medinfo@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.3.4Pharmaceutical 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 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.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®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.4Pharmaceutical 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.3.9.4EV 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    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
    E.1.1.1Medical condition in easily understood language
    Chronic Spontaneous Urticaria
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    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)
    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
    • sleep interference and quality (falling asleep, nighttime awakenings, restfulness upon awakening)
    • improvement in urticaria disease control using the Urticaria Control Test (UCT)
    • angioedema using the Angioedema Activity Score over 7 days (AAS7)
    • the cumulative time period that treated subjects are angioedema occurrence-free using the AAS7


    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 enrolment
    • Subject must have been on a sgAH at approved or increased doses (up to 4x the approved dose) for treatment of CSU for at least 3consecutive
    days immediately prior to the day -14 screening visit (screening visit2) and must have documented current use on the day of screening visit 1
    • This is not applicable for anti-IgE naïve subjects. Subject with CSU who discontinued, is intolerant to, or was an inadequate responder to anti-IgE
    therapies despite being treated with omalizumab 300 mg Q4W for 6 months or higher doses of omalizumab > 2 months (or per local country
    treatment standards) or another anti-IgE therapy.

    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



    • Documented medical history of chronic alcohol or drug abuse within 12 months prior to screening visit 1
    • Evidence of active liver disease at screening, including jaundice or aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN)
    • Subjects who, in the opinion of the investigator, have evidence of active tuberculosis (TB), either treated or untreated, or a positive purified protein derivative (PPD) or QuantiFERON-tuberculosis Gold Plus (QFT-Plus) test for TB during screening. Subjects with an indeterminate QFT-Plus may be enrolled if they have ALL of the following:

    o No symptoms of TB: productive, prolonged cough (> 3 weeks); coughing up blood; fever; night sweats; unexplained appetite loss; unintentional weight loss
    o No evidence of active TB on chest radiograph within 3 months prior to the first dose of investigational product. Note: Chest radiograph is not part of screening procedure and will be the responsibility of the Investigator as this is outside the scope of this protocol

    • History of malignancy, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy?12 months prior to screening or other malignancies treated with apparent success with curative therapy ? 5 years prior to screening visit 1

    • Subject is unable to complete an electronic patient diary or complete questionnaires, or does not meet the required level of compliance (? 80%) with the eDiary during the second phase of the screening period/ H1-antihistamine stabilization period
    o Completion of UAS (daily) for 14 days (?80% compliance) prior to randomization
    o Completion of AAS (daily) for 14 days (? 80% compliance) prior to randomization
    Other Medical Conditions
    • Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study. Any items that are cause for uncertainty must be reviewed and approved by the Medical Monitor
    • History or evidence of severe depression, schizophrenia, previous suicide attempts, or suicidal ideation

    Prior/Concomitant Therapy
    • Treatment with any anti-IgE therapies (eg, omalizumab, ligelizumab) within 6 months prior to screening visit 1
    • Routine (daily or every other day for 5 or more consecutive days) use of systemic corticosteroids within 30 days prior to screening visit 1
    • Routine (daily or every other day for 5 or more consecutive days) use of systemic hydroxychloroquine within 30 days prior to screening visit 1
    • Routine (daily or every other day for 5 or more consecutive days) use of methotrexate, cyclosporine A, cyclophosphamide, tacrolimus, azathioprine, and mycophenolate mofetil within 30 days prior to screening visit 1
    • Undergone plasmapheresis within 30 days prior to screening visit 1
    • Major surgery within 8 weeks prior to screening visit 1 or planned inpatient surgery or hospitalization during the study period
    • Receipt of Ig or blood products within 30 days prior to screening visit 1
    • Regular (daily or every other day) treatment with oral doxepin within 14 days prior to screening visit 1
    • Vaccination with a live or attenuated vaccine within 30 days prior to screening visit 1. Receipt of inactive/killed vaccinations (eg, inactive influenza) is allowed, provided the vaccinations are not administered within 7 days before or after any study visit
    • Known hypersensitivity, including severe hypersensitivity reactions and/or history of anaphylactic shock, to omalizumab or any ingredient of Xolair





    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in UAS7 at week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 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

    • Change from baseline in the CU-Q2oL at week 16
    • Change from baseline in DLQI at week 16
    • Change from baseline in the AE-QoL at week 16
    • Change from baseline in the AECT score at week 16
    • Change from baseline in WPAI-CU score at week 16
    • Cumulative frequency of H1-antihistamine rescue medication utilization from baseline to week 16
    • Serum concentrations of tezepelumab at scheduled visits
    • Subject incidence of adverse events (including serious adverse events)
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days10
    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 No
    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
    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 Decision2021-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-13
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