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    Summary
    EudraCT Number:2019-001792-37
    Sponsor's Protocol Code Number:CQGE031C2302E1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-02-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-001792-37
    A.3Full title of the trial
    A multi-center, double-blinded and open-label extension study to evaluate the efficacy and safety of ligelizumab as retreatment, self-administered therapy and monotherapy in Chronic Spontaneous Urticaria patients who completed studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
    Estudio de extensión multicéntrico, doble ciego y abierto para evaluar la eficacia y seguridad de ligelizumab como retratamiento, terapia autoadministrada y monoterapia en pacientes con urticaria crónica espontánea que han completado los estudios CQGE031C2302, CQGE031C2303, CQGE031C2202 o CQGE031C1301.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of ligelizumab in chronic spontaneous urticaria patients who completed a previous study with ligelizumab
    Estudio de la eficacia y seguridad de ligelizumab en pacientes con urticaria crónica espontánea que han completado un estudio anterior con ligelizumab.
    A.4.1Sponsor's protocol code numberCQGE031C2302E1
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/329/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 90 0353036
    B.5.6E-maileecc.novartis@novartis.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 nameLigelizumab
    D.3.2Product code QGE031
    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 INNLIGELIZUMAB
    D.3.9.2Current sponsor codeQGE031
    D.3.9.3Other descriptive nameAnti-IgE antibody
    D.3.9.4EV Substance CodeSUB177843
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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.IMP: 2
    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 nameLigelizumab
    D.3.2Product code QGE031
    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 INNLIGELIZUMAB
    D.3.9.2Current sponsor codeQGE031
    D.3.9.3Other descriptive nameAnti-IgE antibody
    D.3.9.4EV Substance CodeSUB177843
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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
    Chronic Spontaneous Urticaria
    Urticaria crónica espontánea
    E.1.1.1Medical condition in easily understood language
    Chronic Hives
    Habones Crónicos
    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 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 efficacy of ligelizumab assessed as the proportion of subjects achieving UAS7</=6 after 12 weeks of retreatment, in subjects previously treated in the core studies CQGE031C2302/ CQGE031C2303 as well as in the subset of subjects who previously achieved UAS7<6 in the core studies.
    Evaluar la eficacia de ligelizumab según la proporción de pacientes que alcancen una puntuación semanal de la actividad de la urticaria (UAS7) </=6 después de 12 semanas de retratamiento, en pacientes anteriormente tratados en CQGE031C2302/CQGE031C2303 (los estudios principales), así como en el subgrupo de pacientes que anteriormente hayan alcanzado una UAS7 </=6 en los estudios principales.
    E.2.2Secondary objectives of the trial
    To describe the efficacy of ligelizumab assessed as the proportion of subjects achieving UAS7=0 after 12 weeks of retreatment, in subjects previously treated in the core studies
    • To describe the efficacy of ligelizumab assessed as the reduction from extension study baseline in the UAS7 and its components
    • To describe the efficacy of ligelizumab in achieving an angioedema-free period at Week 12 previously treated in the core studies
    • To describe the efficacy of ligelizumab in achieving Dermatology Life Quality Index = 0-1 at Week 12 previously treated in the core studies
    • To describe the efficacy of ligelizumab in the treatment of CSU (UAS7<6), 12 weeks after starting self-administration.
    • To assess the safety and tolerability of ligelizumab in all subjects
    • To assess the safety and tolerability of ligelizumab pre-filled syringe (PFS)
    • To assess the safety and tolerability of ligelizumab in all subjects who self-administer
    Describir la eficacia de ligelizumab evaluada como la proporción de pacientes que alcancen una UAS7 = 0 después de 12 semanas de retratamiento, en pacientes anteriormente tratados en los estudios principales
    -Describir la eficacia de ligelizumab evaluada como la reducción, respecto a la basal del estudio de extensión, del UAS7 y sus componentes
    -Describir la eficacia de ligelizumab para alcanzar un periodo libre de angioedema en la semana 12 en pacientes anteriormente tratados en los estudios principales
    -Describir la eficacia de ligelizumab para alcanzar una puntuación del Dermatology Life Quality Index (DLQI)=0-1en la semana 12 en pacientes anteriormente tratados en los estudios principales
    y otros objetivos detallados en el protocolo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent
    2. Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
    3. Male and female, adult and adolescent subjects >/=12 years of age
    4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule
    1. Consentimiento informado por escrito.
    2. Pacientes que hayan completado satisfactoriamente todo el periodo de tratamiento y el periodo de seguimiento en cualquiera de los estudios siguientes: CQGE031C2302, CQGE031C2303, CQGE031C2202 o CQGE031C1301.
    3. Pacientes adolescentes y adultos de ambos sexos >/= 12 años de edad.
    4. Voluntad y capacidad para cumplimentar un diario electrónico con los síntomas experimentados a diario durante todo el estudio y seguir el calendario de visitas.
    E.4Principal exclusion criteria
    1. Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment
    2. Use of omalizumab within 16 weeks of Screening
    3. History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes
    4. New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.
    5. Diseases with possible symptoms of urticaria or angioedema
    6. Subjects with evidence of helminthic parasitic infection
    7. Documented history of anaphylaxis
    8. Pregnant or nursing (lactating) women
    1. Uso de fármacos en investigación, salvo los utilizados en los estudios anteriores, en el momento del reclutamiento.
    2. Uso de omalizumab durante las 16 semanas anteriores a la selección.
    3. Antecedentes de hipersensibilidad al fármaco del estudio ligelizumab o sus componentes, o a fármacos de clases químicas similares.
    4. Nueva aparición o signos y síntomas de cualquier forma de urticaria crónica, excepto UCE, durante los estudios anteriores CQGE031C2302, CQGE031C2303 o CQGE031C2202.
    5. Enfermedades con posibles síntomas de urticaria o angioedema.
    6. Sujetos con evidencia de infección parasitaria helmíntica.
    7. Antecedentes documentados de anafilaxia.
    8. Mujeres embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects with well-controlled disease (UAS7 </= 6) at Week 12
    Proporción de pacientes con la enfermedad bien controlada (UAS7</= 6) en semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    • The proportion of subjects with completely controlled disease (UAS7 =0) at Week 12
    • Absolute change from extension study baseline in the UAS7 and its components (ISS7 and HSS7) at Week 12
    • Cumulative number of weeks that subjects achieve angioedema activity score (AAS7) = 0 between extension study baseline and Week 12
    • Percentage of subjects achieving DLQI = 0-1 at Week 12
    • The proportion of subjects with well-controlled disease (UAS7 </= 6), 12 weeks after starting self-administration

    In each dose group, and for each duration of treatment:
    • Occurrence of treatment emergent adverse events during the study
    • Occurrence of treatment emergent serious adverse events during the study
    • Vital signs
    • Lab assessments

    For the duration of treatment:
    • Occurrence of treatment emergent serious adverse events during study Week 12 onwards
    • Vital signs Week 12 onwards
    • Lab assessments Week 12 onwards
    • Occurrence of treatment emergent adverse events
    • Occurrence of treatment emergent serious adverse events
    • Vital signs
    • Lab assessments
    • Proporción de pacientes con la enfermedad completamente controlada (UAS7=0) en semana 12
    • Cambio absoluto en el UAS7 y sus componentes (ISS7 y HSS7) desde la visita basal de la extensión hasta semana 12
    • Número acumulado de semanas en la que los pacientes alcanzan una puntuación de la actividad del angioedema (AAS7)=0 entre la visita basal de la extensión y la semana 12.
    • Porcentaje de pacientes que alcanzan un DLQI=0-1 en semana 12.
    • Proporción de pacientes con la enfermedad bien controlada (UAS7</= 6) tras 12 semanas de empezar la autoadministración.
    En cada grupo de dosis y durante cada duración del tratamiento:
    • Aparición de efectos adversos derivados del tratamiento durante el ensayo
    • Aparición de efectos adversos graves derivados del tratamiento durante el ensayo
    • Signos vitales
    • Evaluaciones de laboratorio
    Durante el tratamiento:
    • Aparición de efectos adversos graves derivados del tratamiento a partir de semana 12
    • Signos vitales a partir de semana 12
    • Evaluaciones de laboratorio a partir de semana 12
    • Aparición de efectos adversos derivados del tratamiento durante el ensayo
    • Aparición de efectos adversos graves derivados del tratamiento durante el ensayo
    • Signos vitales
    • Evaluaciones de laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study; including Week 12 and each protocol defined study visit
    A lo largo del estudio, incluyendo semana 12 y cada visita de ensayo definida por protocolo.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA102
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Egypt
    Estonia
    Finland
    France
    Germany
    Greece
    Guatemala
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Lebanon
    Malaysia
    Mexico
    Morocco
    Netherlands
    Oman
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Tunisia
    Turkey
    United Kingdom
    United States
    Vietnam
    E.8.7Trial has a data monitoring committee Yes
    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
    Último paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years5
    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 Yes
    F.1.1Number of subjects for this age range: 50
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 351
    F.4.2.2In the whole clinical trial 800
    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)
    Subject will continue in this extension study to completion or until the investigational treatment becomes available in the country of the participants, whichever occurs first.
    El paciente continuará en el estudio de extensión hasta que lo complete o hasta que el tratamiento en investigación esté disponible en el país de los participantes, lo que ocurra primero.
    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 Decision2020-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-09-01
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