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    Summary
    EudraCT Number:2014-005559-16
    Sponsor's Protocol Code Number:CQGE031C2201
    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:2015-06-02
    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 number2014-005559-16
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo and active-controlled phase 2b dose-finding study of QGE031 as add-on therapy to investigate the efficacy and safety in patients with Chronic Spontaneous Urticaria (CSU)
    Estudio multicéntrico fase 2b, aleatorizado, doble ciego, controlado con placebo y fármaco activo, de búsqueda de dosis para investigar la eficacia y la seguridad de QGE031 como tratamiento complementario en pacientes con urticaria espontánea crónica (UEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety and efficacy study to find the dose of QGE031 as add-on therapy in patients with Chronic Spontaneous Urticaria (CSU)
    Estudio de eficacia y la seguridad para encontrar la dosis de QGE031 como tratamiento complementario en pacientes con urticaria espontánea crónica (UEC)
    A.4.1Sponsor's protocol code numberCQGE031C2201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01716754
    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 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 pointDepartamento Médico (ICRO)
    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 number34900353036
    B.5.5Fax number34932479903
    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.3.2Product 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 INNLegilizumab
    D.3.9.2Current sponsor codeQGE031
    D.3.9.3Other descriptive nameAnti-IgE antibody
    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 Yes
    D.3.11.13.1Other medicinal product typeAnti IgE
    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 150 mg powder and solvent for solution for injection
    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.3.1Product nameXolair 150 mg powder and solvent for solution for injection
    D.3.2Product code IGE025
    D.3.4Pharmaceutical form Powder and solvent 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.3.9.2Current sponsor codeIGE025
    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 Yes
    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 Espontánea Crónica
    E.1.1.1Medical condition in easily understood language
    Chronic Hives
    Uritcaria Crónica
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10009159
    E.1.2Term Chronic urticaria
    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
    To establish the dose-response relationship of QGE031 with respect to achievement of complete hives response at Week 12 in patients with CSU when added to H1-AH alone or in combination with H2-AH and/or a LTRA
    Establecer la relación dosis-respuesta de QGE031 con respecto a la consecución de una respuesta completa (evaluando la roncha) en la semana 12 en pacientes con UEC añadido a H1-AH en monoterapia o en combinación con H2-AH y/o un ARLT.
    E.2.2Secondary objectives of the trial
    Evaluate efficacy of QGE031 compared to omalizumab 300 mg with respect to achievement of complete hives response at Week 12
    Evaluate the efficacy of individual QGE031 doses of 24 mg, 72 mg and 240 mg s.c. compared to omalizumab 300 mg with respect to achievement of complete hives response
    at Week 20
    Evaluate the efficacy of QGE031 doses of 24 mg, 72 mg and 240 mg s.c. versus placebo and omalizumab 300 mg:
    Change from Baseline in Hives Severity Score (HSS7)
    Change from Baseline in Itch Severity Score (ISS7)
    Change from Baseline in Urticaria Activity Score (UAS7)
    Evaluate the safety and tolerability of QGE031 versus placebo and omalizumab 300 mg
    Evaluar la eficacia de QGE031 (basándose en el modelo dosis-respuesta seleccionado) en comparación con 300 mg de omalizumab con respecto a la consecución de una respuesta completa (evaluando la roncha) en la semana 12.
    Evaluar la eficacia de las dosis individuales de QGE031 de 24, 72 y 240 mg administrados por vía subcutánea en comparación con 300 mg de omalizumab con respecto a la consecución de una respuesta completa (evaluando la roncha) en la semana 20.
    Evaluar la eficacia de las dosis de QGE031 de 24, 72 y 240 mg s.c. frente a placebo y 300 mg de omalizumab en pacientes con UEC en términos de:
    Cambio con respecto a la basal en la puntuación de la intensidad de la roncha (HSS7)
    Cambio con respecto a la basal en la puntuación de la intensidad del picor (PGP7)
    Cambio con respecto a la basal en la puntuación de la actividad de la urticaria (PGU7)
    Evaluar la seguridad y la tolerabilidad de QGE031 frente a placebo y 300 mg de omalizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female adult patients aged >/=18 to </= 75 years.
    Diagnosis of CSU (with or without urticarial dermographism when testing for dermographism) refractory to H1-AH at approved or increased doses alone, or in combination with H2-AH and/or leukotriene receptor antagonist (LTRA) defined by all of the following:
    The presence of itch and hives for >/= 6 consecutive weeks at any time prior to
    enrollment despite current use of H1-AH (up to four times the approved dosage),
    or in combination with H2-AH and/or LTRA treatment during this time period
    UAS7 score (range 0-42) >/=16 and HSS7 (range 0-21) >/=8 during 7 days prior to randomization (Day 1)
    In-clinic UAS >/= 4 on at least one of the screening visit days (Day -14, Day -7, or Day 1)
    Patients must have been on H1-AH at approved or increased doses (up to fourfold) alone or in combination with H2-AH and/or a LTRA for treatment of CSU for at
    least the 3 consecutive days immediately prior to the Day -14 screening visit and must have documented current use on the day of the initial screening visit
    CSU diagnosis for >/=6 months
    Pacientes adultos de ambos sexos >/= 18 y </= 75 años de edad.
    El diagnóstico de UEC (con dermografismo urticarial o sin él, en caso de que se realicen pruebas pertinentes) refractaria a H1-AH en las dosis aprobadas o aumentadas, en monoterapia o en combinación con H2-AH y/o un receptor antagonista de leucotrienos (ARLT) en el momento de la aleatorización, definido para la totalidad de los elementos siguientes:
    La presencia de picor y roncha durante >/= 6 semanas consecutivas en cualquier momento anterior a la inclusión a pesar del uso actual de H1-AH (hasta cuatro veces la dosis aprobada), o en combinación con el tratamiento con H2-AH y/o ARLT durante este tiempo.
    Puntuación de UAS7 (rango 0-42) >/= 16 y HSS7 (rango 0-21) >/= 8 durante 7 días antes de la aleatorización (día 1).
    UAS en la clínica >/= 4 en al menos uno de los días de visita de selección (día -14, día -7 o día 1).
    Los pacientes deben haber recibido H1-AH en dosis aprobadas o aumentadas (hasta el cuádruple) en monoterapia o en combinación con H2-AH y/o un ARLT para el tratamiento de la UEC durante al menos los 3 días consecutivas inmediatamente anteriores a la visita de selección del día -14 y debe haberse documentado el uso actual el día de la visita de selección inicial.
    Diagnóstico de UEC durante >/= 6 meses.
    E.4Principal exclusion criteria
    Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lifes prior to Visit 1, whichever is longer.
    History of hypersensitivity to any of the study drugs or its components, or to drugs of similar chemical classes.
    Clearly defined underlying etiology for chronic urticarias other than CSU. This includes the following:
    Inducible urticaria: urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure-,
    aquagenic-, cholinergic-, or contact-urticaria
    Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
    Patients with a stool examination positive for ova or parasites (at screening); re-screening may be considered if a repeat stool examination is negative following treatment.
    Any other skin disease associated with chronic itching that might confound the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus etc.)
    Previous exposure to omalizumab or QGE031
    History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to randomization
    Inability to comply with study and follow-up procedures
    Use of prohibited treatment detailed in protocol
    Uso de otros fármacos en investigación en el momento de la inclusión, o durante los 30 días o 5 semividas anteriores a la visita 1, aquello que sea más largo.
    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).
    Etiología subyacente claramente definida para urticarias crónicas, salvo UEC. Esto incluye lo siguiente:
    Urticaria inducible: urticaria factitia, por frío, calor, sol, presión, presión retardada, acuagénica, colinérgica o de contacto.
    Enfermedades con síntomas posibles 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 resultado positivo de huevos o parásitos en el análisis de heces (en la selección); puede considerarse volver a realizar la selección si se repite el análisis de heces y el resultado es negativo tras el tratamiento.
    Cualquier otra enfermedad cutánea asociada con el picor crónico que pueda confundir las evaluaciones y los resultados del estudio (p. ej., dermatitis atópica, penfigoide bulloso, dermatitis herpetiforme, prurito senil, etc.).
    Exposición previa a omalizumab o QGE031.
    Antecedentes o evidencia de alcoholismo o toxicomanía en curso durante los últimos 6 meses antes de la aleatorización.
    Incapacidad de llevar a cabo los procedimientos de estudio y de seguimiento.
    Uso de tratamiento prohibido según lo especificado en el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Achieving complete hives response at Week 12. Complete hives response is defined as a HSS7 score of 0. Analogously, complete itch
    response and complete UAS7 response are defined as an ISS7 and UAS7 score of 0, respectively.
    consecución de una respuesta completa (evaluando la roncha) en la semana 12.
    La respuesta completa (evaluando la roncha) se define como una puntuación HSS7 de 0. De forma análoga, la respuesta completa (evaluando el picor) y la respuesta completa UAS7 se definen como una puntuación ISS7 y UAS7 de 0, respectivamente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 12
    en la semana 12
    E.5.2Secondary end point(s)
    Evaluate the efficacy of QGE031 based on the selected dose response model compared to omalizumab 300 mg with respect to achievement of complete hives response.
    Evaluate the efficacy of individual QGE031 doses of 24 mg, 72 mg and 240 mg s.c. compared to omalizumab 300 mg with respect to achievement of complete hives response
    Evaluate the efficacy of QGE031 doses of 24 mg, 72 mg and 240 mg s.c. versus placebo and omalizumab 300 mg in patients with CSU, in terms of:
    Change from Baseline in Hives Severity Score (HSS7)
    Change from Baseline in Itch Severity Score (ISS7)
    Change from Baseline in Urticaria Activity Score (UAS7)
    evaluate the safety (including immunogenicity) and tolerability of QGE031 versus placebo and omalizumab 300 mg in patients with CSU particularly in regards to
    ECG
    adverse events
    vital signs
    and clinical laboratory
    Evaluar la eficacia de QGE031 basándose en el modelo dosis-respuesta seleccionado en comparación con 300 mg de omalizumab con respecto a la consecución de una respuesta completa (evaluando la roncha).
    Evaluar la eficacia de las dosis individuales de QGE031 de 24, 72 y 240 mg administrados por vía subcutánea en comparación con 300 mg de omalizumab con respecto a la consecución de una respuesta completa (evaluando la roncha).
    Evaluar la eficacia de las dosis de QGE031 de 24, 72 y 240 mg s.c. frente a placebo y 300 mg de omalizumab en pacientes con UEC en términos de:
    Cambio con respecto a la basal en la puntuación de la intensidad de la roncha (HSS7)
    Cambio con respecto a la basal en la puntuación de la intensidad del picor (PGP7)
    Cambio con respecto a la basal en la puntuación de la actividad de la urticaria (PGU7)
    Evaluar la seguridad (incluida la inmunogenicidad) y la tolerabilidad de QGE031 frente a placebo y 300 mg de omalizumab en pacientes con UEC, especialmente en relación a ECG, acontecimientos adversos, constantes vitales y pruebas analíticas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 12 and Week 20 (as indicated in protocol)
    en la semana 12 y 20 (como se indica 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 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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Calidad de Vida
    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 trial6
    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 EEA31
    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
    Australia
    Canada
    Germany
    Greece
    Japan
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    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
    LVLS
    Última Visita Último Paciente
    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 months8
    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 months8
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 145
    F.4.2.2In the whole clinical trial 360
    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)
    Not applicable.
    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 Decision2015-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
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