Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-005339-56
    Sponsor's Protocol Code Number:CQGE031G12301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-11
    Trial 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 number2020-005339-56
    A.3Full title of the trial
    A 52 week, multi-center, randomized, double-blind placebo-controlled study to assess the clinical efficacy and safety of ligelizumab (QGE031) in decreasing the sensitivity to peanuts in patients with peanut allergy
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo de 52 semanas de duración para evaluar la eficacia clínica y la seguridad de ligelizumab (QGE031) en la disminución de la sensibilidad a los cacahuetes en pacientes con alergia al cacahuete.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of QGE031 (ligelizumab) in patients with peanut allergy
    Eficacia y seguridad de ligelizumab (QGE031) en pacientes con alergia al cacahuete.
    A.4.1Sponsor's protocol code numberCQGE031G12301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04984876
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/372/2021
    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 number34 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    Allergy, Peanut
    Alergia, cacahuete
    E.1.1.1Medical condition in easily understood language
    Peanut allergy
    Alergia al cacahuete
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10034202
    E.1.2Term Peanut allergy
    E.1.2System Organ Class 100000004870
    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 240 mg and 120 mg (SCq4w) compared to placebo, as measured by the proportion of participants who can tolerate a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the Double Blind Placebo Controlled Food Challenge (DBPCFC) at Week 12
    Evaluar la eficacia de ligelizumab 240 mg y 120 mg (SC c4s), comparado con placebo, según la proporción de participantes que pueden tolerar una dosis única >/=600 mg (dosis acumulada tolerada de 1044 mg) de proteína de cacahuete sin presentar síntomas limitantes de dosis durante la prueba de provocación alimentaria a doble ciego controlada con placebo (PADCCP) en la semana 12.
    E.2.2Secondary objectives of the trial
    Key:
    -To evaluate the efficacy of ligelizumab 240mg and 120mg (SCq4w), compared to placebo, as measured by
    --the proportion of participants who can tolerate a single dose of ≥ 1000mg (2044mg cum. tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC at w12
    --the proportion of participants who can tolerate a single dose of 3000mg (5044mg cum. tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC at w12
    --the maximum symptom severity at any single challenge dose up to and including 1000mg of peanut protein during the DBPCFC at w12
    -To evaluate the efficacy of 8 weeks of placebo treatment followed by 4 weeks of ligelizumab 120mg and 240mg (SCq4w) treatment compared to 12 weeks of placebo treatment, as measured by the proportion of participants who can tolerate a single dose ≥1000mg of peanut protein without dose-limiting symptoms during the DBPCFC at w12

    Other 2ndary objectives:
    -listed in the clinical study protocol
    Principales:
    - Evaluar la eficacia de ligelizumab 240 mg y 120 mg (SC c4s), comparado con placebo medido según:
    -- la proporción de participantes que pueden tolerar una dosis única >/=1000 mg (dosis acumulada tolerada de 2044 mg) de proteína de cacahuete sin presentar síntomas limitantes de dosis durante la PADCCP en la semana 12.
    -- la proporción de participantes que pueden tolerar una dosis única de 3000 mg (dosis acumulada tolerada de 5044 mg) de proteína de cacahuete sin presentar síntomas limitantes de dosis durante la PADCCP en la semana 12.
    -- la máxima severidad del síntoma a cualquier dosis única hasta 1000 mg, inclusive, de proteína de cacahuete durante la PADCCP en la semana 12.

    Para mas objetivos secundarios, ver protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female participants who are ≥ 6 and ≤ 55 years of age at the time of signing informed consent/assent.
    - Documented medical history of allergy to peanuts or peanut-containing foods.
    - Positive peanut-specific immunoglobulin E (peanut sIgE), ≥ 6 kUA/L at Screening visit 1 (Screening 1)
    - Positive skin prick test (SPT) for peanut allergen at Screening 1 defined as an average diameter (Longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to saline control.
    - A positive peanut DBPCFC at baseline (Screening Visit 2, Part 1 and Part 2 DBPCFC) defined as the occurrence of dose-limiting symptoms at a single dose ≤ 100 mg of peanut protein, and no occurrence on placebo. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.
    - Participants must weigh ≥ 20 kg at Screening 1.

    Other protocol-defined inclusion criteria may apply.
    -Participantes de ambos sexos entre >=/6 y </=55 años de edad en el momento de la firma del consentimiento/asentimiento informado.
    -Historia clínica documentada de alergia al cacahuete o a alimentos que contienen cacahuete.
    -Niveles positivos de inmunoglobulina E (IgE) específica del cacahuete >/=6 kUA/l en la visita de selección 1 (selección 1).
    -Prueba cutánea por punción (PCP) positiva para alérgeno del cacahuete en la selección 1 definida como un diámetro medio (diámetro más largo y diámetro ortogonal en el punto medio) >/=4 mm de la roncha comparado con control de solución salina.
    -PADCCP con cacahuete positiva en la basal (visita de selección 2, parte 1 y parte 2 de la PADCCP) definida como la aparición de síntomas limitantes de dosis a una dosis única </=100 mg de proteína de cacahuete y ningún síntoma con placebo. Para poder proceder con la PADCCP deben cumplirse todos los demás criterios de elegibilidad.
    -Los participantes deben pesar >/=20 kg en la selección 1.

    Para otros criterios ver protocolo
    E.4Principal exclusion criteria
    - Total IgE >2000 IU/mL at Screening 1.
    - History of severe or life-threatening hypersensitivity event needing an ICU admission or intubation within 60 days prior to baseline DBPCFC (Screening visit 2).
    - Participants with uncontrolled asthma (according to GINA guidelines, GINA 2020) who meet any of the following criteria:
    - FEV1 <80% of subject’s predicted normal value at Screening visit 1
    - One hospitalization for asthma within 12 months prior to Screening visit 1

    Other protocol-defined exclusion criteria may apply.
    - IgE total >2000 UI/ml en la selección 1.
    - Antecedentes de un evento de hipersensibilidad grave o potencialmente mortal que requiera ingreso en la UCI o intubación durante los 60 días anteriores a la PADCCP basal (visita de selección 2).
    - Participantes con asma no controlada (según las guías GINA 2020) que cumplan alguno de los siguientes criterios:
    -- FEV1 <80 % del valor teórico normal del paciente en la visita de selección 1.
    -- Una hospitalización por asma durante los 12 meses anteriores a la visita de selección 1.

    Para otros criterios ver protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Responder status defined as tolerating a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the Double Blind Placebo Controlled Food Challenge (DBPCFC) conducted at Week 12
    Estado de los respondedores definido como tolerar una dosis única >/=600 mg (dosis acumulada tolerada de 1044 mg) de proteína de cacahuete sin presentar síntomas limitantes de dosis durante la prueba de provocación alimentaria a doble ciego controlada con placebo (PADCCP) en la semana 12..
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    semana 12
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    - Responder status defined as tolerating a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC conducted at Week 12
    - Responder status defined as tolerating a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC conducted at Week 12
    - Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000 mg during the DBPCFC conducted at Week 12. Symptom severity will be categorized as 4 levels: None, Mild, Moderate, Severe
    - Responder status defined as tolerating a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC conducted at Week 12 (8 weeks of placebo + 4 weeks of ligelizumab treatment vs. 12 weeks of placebo)

    Other secondary endpoints:
    - listed in the clinical study protocol
    Las variables secundarias principales son:
    -Estado de los respondedores definido como tolerar una dosis única >/=1000 mg (dosis acumulada tolerada de 2044 mg) de proteína de cacahuete sin presentar síntomas limitantes de dosis durante la PADCCP en la semana 12.
    -Estado de los respondedores definido como tolerar una dosis única de 3000 mg (dosis acumulada tolerada de 5044 mg) de proteína de cacahuete sin presentar síntomas limitantes de dosis durante la PADCCP en la semana 12.
    -Máxima severidad de los síntomas que se presenten con cualquier dosis de proteína de cacahuete hasta 1000 mg, inclusive, durante la PADCCP realizada en la semana 12. La severidad de los síntomas se categorizará en 4 niveles: ninguna, leve, moderada y grave.
    -Estado de los respondedores definido como que los participantes toleren una dosis única >/=1000 mg (dosis acumulada tolerada de 2044 mg) de proteína de cacahuete sin presentar síntomas limitantes de dosis durante la PADCCP en la semana 12 (8 semanas de placebo + 4 semanas de tratamiento con ligelizumab frente a 12 semanas de placebo).

    Otras variables secundarias:
    -Por favor ver protocolo
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Week 12
    - Week 12
    - Week 12
    - Week 12

    Timepoints of other secondary endpoints are listed in the clinical study protocol.
    -Semana 12
    -Semana 12
    -Semana 12
    -Semana 12

    Para mas variables ver 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 EEA23
    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
    Japan
    South Africa
    United States
    Denmark
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    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
    Study completion is defined as when the last participant finishes the End of Study visit (Week 68). This includes any repeat assessments associated with this visit with full documentation and follow-up by the Investigator or, in the event of an early study termination decision, the date of that decision.
    La finalización del estudio se define cuando el último participante finaliza la visita de fin del estudio (semana 68). Esto incluye cualquier evaluación repetida asociada con esta visita con la documentación completa y el seguimiento por parte del investigador o, en el caso de una decisión de terminación anticipada del estudio, la fecha de esa decisión.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 324
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 162
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 162
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 162
    F.1.3Elderly (>=65 years) No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 486
    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)
    An Extension Study is planned. At sites participating in the Extension Study, participants who successfully complete 52 weeks of treatment in this study will be offered participation in the Extension Study. Participation in the Extension Study will be optional.
    Se planea un estudio de extensión. En los sitios que participan en el Estudio de extensión, a los participantes que completen con éxito 52 semanas de tratamiento en este estudio se les ofrecerá la participación en el Estudio de extensión. La participación en el Estudio de Extensión será opcional.
    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 Decision2022-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-02
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 02 23:09:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA