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    Summary
    EudraCT Number:2018-000840-24
    Sponsor's Protocol Code Number:CQGE031C2303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-09-05
    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 number2018-000840-24
    A.3Full title of the trial
    A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines
    Estudio multicéntrico, aleatorizado, doble ciego, con control activo y placebo para investigar la eficacia y seguridad de ligelizumab (QGE031) en el tratamiento de la urticaria crónica espontánea (UCE) en adolescentes y adultos inadecuadamente controlados con antihistamínicos H1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III study of efficacy and safety of ligelizumab in the treatment of Chronic Spontaneous Urticaria in adolescents and adults inadequately controlled with H1-antihistamines
    Estudio de fase III de eficacia y seguridad del ligelizumab en el tratamiento de la UCE en adolescentes y adultos inadecuadamente controlados con antihistamínicos H1
    A.4.1Sponsor's protocol code numberCQGE031C2303
    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 Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900 353036
    B.5.5Fax number3493 2479903
    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 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 Powder 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 INNOMALIZUMAB
    D.3.9.1CAS number 242138-07-4
    D.3.9.3Other descriptive nameAnti-IgE antibody
    D.3.9.4EV Substance CodeSUB12543MIG
    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 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
    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
    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
    The primary objective of the study is to demonstrate that ligelizumab is superior to placebo and superior to omalizumab 300 mg q4w in change from baseline in UAS7 at Week 12
    El objetivo principal del estudio es demostrar que ligelizumab (72 mg C4S y/o 120 mg C4S) es superior a placebo y superior a omalizumab 300 mg C4S en el cambio en el UAS7 en la semana 12 respecto a la basal.
    E.2.2Secondary objectives of the trial
    To demonstrate that a greater proportion of subjects achieve UAS7=0 at Week 12 who are treated with ligelizumab 72 mg q4w and/or 120 mg q4w compared to placebo-treated subjects and compared with omalizumab 300 mg q4w treated subjects

    To demonstrate the superiority of ligelizumab 72 mg q4w and/or 120 mg q4w treated subjects with respect to a reduction from baseline in the weekly itch severity score at Week 12 compared to placebo-treated subjects and omalizumab 300 mg q4w treated subjects

    To demonstrate that a greater proportion of subjects who are treated with ligelizumab q4w achieve DLQI= 0-1 at Week 12 compared to placebo-treated subjects and omalizumab 300 mg q4w treated subjects

    To demonstrate that the ligelizumab 72 mg q4w and/or 120 mg q4w treated subjects have a longer angioedema occurrence-free period compared with placebo-treated subjects and omalizumab 300 mg q4w treated subjects.

    To demonstrate the safety and tolerability of ligelizumab 72 mg q4w and 120 mg q4w
    Demostrar que una proporción mayor de pacientes que son tratados con ligelizumab 72 mg C4S y/o 120 mg C4S consiguen una UAS7 = 0 en la semana 12 comparado con los pacientes que son tratados con placebo y con los pacientes que son tratados con omalizumab 300 mg C4S.
    Demostrar la superioridad de los pacientes tratados con ligelizumab 72 mg C4S y/o 120 mg C4S en relación con la reducción respecto a la basal en la puntuación semanal de la intensidad del picor en la semana 12 comparado con pacientes tratados con placebo y pacientes tratados con omalizumab 300 mg C4S.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Signed informed consent must be obtained prior to participation in the study. The subject´s, parent´s or legal guardian´s signed written informed consent and child´s assent, if appropriate, must be obtained before any assessment is performed.
    - Male and female subjects >/= 12 years of age at the time of screening.
    - CSU diagnosis for >/= 6 months.
    - Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
    - The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
    - UAS7 score (range 0-42) >/= 16 and HSS7 (range 0-21) >/= 8 during the 7 days prior to randomization (Visit 110, Day 1)
    - Subjects must be on H1-antihistamine at only approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
    - Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
    Other protocol-defined inclusion criteria may apply
    -Se deberá obtener el consentimiento informado firmado antes de la participación en el estudio. Se deberá obtener la firma del consentimiento informado por parte del sujeto, sus progenitores o su tutor legal y el asentimiento del niño, si procede, antes de realizar cualquier evaluación. Téngase en cuenta que si el paciente alcanza la edad en la que puede otorgar el consentimiento (según la legislación local) mientras participa en el estudio, deberá firmar también el consentimiento informado (CI) correspondiente del estudio en la siguiente visita.
    - Hombres o mujeres de >/= 12 años de edad en el momento de la selección. (NOTA: el reclutamiento de pacientes adolescentes de entre 12 y 18 años será acorde a los requisitos locales).
    - Diagnóstico de UCE >/= 6 meses.
    - Diagnóstico de UCE refractaria a dosis autorizadas de antihistamínicos H1 en el momento de la aleatorización, definido por las siguientes características:
    - Presencia de picor y habones durante >/= 6 semanas consecutivas en cualquier momento previo a la visita 1 (del día -28 al día -14) a pesar del uso actual de antihistamínicos H1 no-sedantes.
    - Puntuación de UAS7 (rango 0-42) >/=16 y HSS7 (rango 0-21) >/=8 durante los 7 días previos a la aleatorización (visita 110, día 1).
    - Los pacientes deben estar en tratamiento con dosis autorizadas de antihistamínicos H1 para la UCE a partir de la visita 1 (del día -28 al día -14).
    - Voluntad y capacidad para lcumplimentar un diario electrónico con los síntomas experimentados a diario durante todo el estudio y seguir el calendario de visitas.
    Otros criterios de inclusión definidos en el protocol pueden proceder.
    E.4Principal exclusion criteria
    History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
    ● Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergicor contact-urticaria.
    ● Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
    ● Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
    ● Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
    ● Prior exposure to ligelizumab or omalizumab.
    ● Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1.
    ● Other protocol-defined exclusion criteria may apply
    Antecedentes de hipersensibilidad a cualquiera de los fármacos del estudio o a sus excipientes, o a fármacos de clases químicas similares (es decir, anticuerpos murinos, quiméricos o humanos).
    -Pacientes que tienen una causa claramente definida de su urticaria crónica, diferente a la UCE. Esto incluye, pero no se limita a las siguientes: dermografismo sintomático (urticaria facticia), urticaria por el frío, por el calor, solar, por presión, por presión retardada, acuagénica, colinérgica o de contacto.
    -Enfermedades diferentes a la urticaria crónica con síntomas de urticaria o angioedema como vasculitis urticarial, eritema multiforme, mastocitosis cutánea (urticaria pigmentosa) y angioedema hereditario o adquirido (p. ej., debido a una deficiencia del inhibidor C1).
    -Pacientes con una infección parasitaria helmíntica evidenciada por un resultado positivo de un organismo patógeno presente en las heces, según las directrices locales. Se realizará la selección de todos los pacientes en la visita 1. Si la prueba de heces que identifica el organismo patógeno es positiva, el sujeto no se aleatorizará y no podrá volver a ser seleccionado.
    -Cualquier otra enfermedad cutánea asociada a picor crónico que pueda influir las opiniones de los investigadores, las evaluaciones y los resultados del estudio (p. ej., dermatitis atópica, penfigoide bulloso, dermatitis herpetiforme, prurito senil, etc.),
    -Exposición previa a ligelizumab o a omalizumab.
    -Cualquier antihistamínico H2, antagonistas de los receptores de leucotrienos (montelukast o zafirlukast) o antihistamínicos H1 utilizados en dosis superiores a las autorizadas tras la visita 1.
    Otros criterios de exclusión definidos en el protocol pueden proceder.
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change from baseline in UAS7 at Week 12
    Cambio absoluto respecto a la visita basal en la puntuación UAS7 en la semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    ● Complete absence of hives and itch at Week 12, assessed as percentage of subjects achieving UAS7 = 0
    ● Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 12
    ● No impact on subjects quality of life at Week 12, assessed as % of subjects achieving DLQI = 0-1
    ● Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12
    ● Occurrence of treatment emergent adverse events during the study
    ● Occurrence of treatment emergent serious adverse events during the study
    -Completa ausencia de habones y picores en la semana 12, estimado por el porcentaje de sujetos que alcancen UAS7 = 0.
    - Mejora de la severidad de los picores, estimado por el cambio absolute respecto a la visita basal en la puntuación UAS7 en la semana 12
    - El no impacto en la calidad de vida de los sujetos en la semana 12, estimado por el % sujectos que alcancen DLQI = 0-1
    - El número acumulado de semanas en las que los sujetos alcancen las repuestas AAS7 = 0 entre la visita basal y la semana 12.
    - La aparición de eventos adversos emergentes durante el estudio.
    - La aparición de eventos adversos graves emergentes durante el estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks and at each protocol defined study visit
    12 semanas y cada visita definida en el 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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    To evaluate the use of rescue medication
    Calidad de vida
    Evaluar el uso de la medicación de rescate
    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 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 Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA91
    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
    Belgium
    Brazil
    Chile
    Egypt
    Estonia
    Finland
    France
    Germany
    India
    Israel
    Italy
    Japan
    Lebanon
    Mexico
    Netherlands
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Spain
    Taiwan
    Tunisia
    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
    Completion of the study will be considered when all patients will have
    completed 52 weeks of treatment epoch and the full follow up epoch or
    have prematurely withdrawn from the study
    El estudio se considerará completado cuando todos los pacientes hayan completado 52 semanas de tiempo de tratamiento y el tiempo de seguimiento completo o que hayan salido prematuramente del estudio.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days20
    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: 950
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 473
    F.4.2.2In the whole clinical trial 1050
    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)
    Patients will be eligible for post-trial access after completion of the
    study.
    Los pacientes serán elegibles para el acceso al post estudio tras completar el estudio
    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 Decision2018-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-14
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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