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    Summary
    EudraCT Number:2020-005339-56
    Sponsor's Protocol Code Number:CQGE031G12301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-04
    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 ConcernedFrance - ANSM
    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
    Etude multicentrique de 52 semaines, randomisée, en double aveugle, contrôlée
    par placebo évaluant l’efficacité et la sécurité d’emploi du ligélizumab (QGE031)
    dans la diminution de la sensibilité à l’arachide chez des patients allergiques à
    l’arachide
    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
    Efficacité et la sécurité d’emploi du ligélizumab (QGE031) chez des patients allergiques à l’arachide
    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 Pharma AG
    B.1.3.4CountrySwitzerland
    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 Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address8/10 rue Henry Sainte Claire Deville, CS 40150
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92563
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 5547 6600
    B.5.5Fax number+33 1 5547 6100
    B.5.6E-mailicm.phfr@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
    allergie, arachide
    E.1.1.1Medical condition in easily understood language
    Peanut allergy
    allergiques à l’arachide
    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
    Evaluer par rapport à un placebo l’efficacité du ligélizumab 240 mg et 120 mg administré par voie sous-cutanée toutes les 4 semaines, mesurée par la proportion de patients pouvant tolérer une dose unique ≥ 600 mg de protéines d’arachide (dose cumulée tolérée de 1044 mg) sans symptômes limitant la dose durant le test de provocation par voie orale en double aveugle contrôlé par placebo (TPODACP) réalisé à la Semaine 12
    E.2.2Secondary objectives of the trial
    Key:
    -To evaluate the efficacy of ligelizumab 240 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
    - Evaluer par rapport à un placebo l’efficacité du ligélizumab 240 et 120 mg administré par voie sous-cutanée toutes les 4 semaines, mesurée par la proportion de patients pouvant tolérer une dose unique ≥ 1000 mg de protéines d’arachide (dose cumulée tolérée de 2044 mg) sans symptômes limitant la dose durant le TPODACP à la S12
    - proportion de patients pouvant tolérer une dose unique de 3000 mg de protéines d’arachide (dose cumulée tolérée de 5044 mg) sans symptômes limitant la dose durant le TPODACP à la S12
    - sévérité maximale des symptômes survenant à toute dose allant jusqu’à 1000 mg (incluse) de protéines d’arachide durant le TPODACP à la S12
    - Evaluer l’efficacité de 8 semaines de placebo suivies de 4 semaines de traitement par ligélizumab 240 et 120 mg administré par voie sous-cutanée toutes les 4 semaines, comparée à 12 semaines de placebo, mesurée par la proportion de patients pouvant tolérer une dose unique ≥1000 mg de protéines d’arachide sans symptômes limitant la dose
    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.
    -Patients de sexe masculin ou féminin âgés de 6 à 55 ans au moment de la signature du consentement éclairé/de l’assentiment.
    - Antécédents médicaux documentés d’allergie à l’arachide ou à des aliments contenant de l’arachide.
    - Patients positifs pour les IgE spécifiques de l’arachide, définies par une concentration ≥ 6 kUA/l à la visite de sélection 1.
    -Patients présentant un TPODACP à l’arachide positif à la visite de sélection 2, partie 1 et partie 2 du TPODACP, défini par l’apparition de symptômes limitant la dose à une dose unique ≤ 100 mg de protéines d’arachide et par l’absence de symptômes avec la formulation de placebo. Tous les autres critères de sélection doivent être remplis pour pouvoir réaliser le TPODACP.
    -Patients pesant ≥ 20 kg à la visite de sélection 1.

    Auther protocol défini criteres d'inclusion peut s'appliquer
    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 totales > 2000 UI/ml à la visite de sélection 1.
    -Antécédents de réaction d’hypersensibilité sévère ou ayant engagé le pronostic vital et ayant nécessité une admission en unité de soins intensifs ou une intubation dans les 60 jours précédant le TPODACP de la baseline (visite de sélection 2).
    - Patients atteints d’asthme non contrôlé (selon les critères GINA [pour Global initiative for asthma] en 2020) répondant à l’un des critères suivants:
    -(VEMS) < 80 % de la normale prédite pour le patient à la visite de sélection 1
    - Une hospitalisation pour l’asthme dans les 12 mois précédant la visite de sélection 1.

    Auther protocol défini criteres de non inclusion peut s'appliquer
    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
    Le critère d’évaluation principal est la proportion de patients tolérant une dose unique ≥ 600 mg (dose cumulée tolérée de 1044 mg) de protéines d’arachide sans symptoms limitant la dose durant le TPODACP réalisé à la fin des 12 semaines de traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semaine 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
    Les critères d’évaluation secondaires:
    - Le statut de répondeur, défini par la tolérance d’une dose unique ≥ 1000 mg (dose cumulée tolérée de 2044 mg) de protéines d’arachide sans symptômes limitant la dose à la Semaine 12
    - Le statut de répondeur, défini par la tolérance d’une dose unique de 3000 mg (dose cumulée tolérée de 5044 mg) de protéines d’arachide sans symptoms limitant la dose à la Semaine 12
    - La sévérité maximale des symptômes survenant à toute dose de proteins d’arachide, jusqu’à 1000 mg (incluse) durant le TPODACP réalisé à la Semaine 12. L’intensité des symptômes sera déclinée en 4 niveaux : aucun symptôme ; légère ; modérée ; sévère
    - Le statut de répondeur, défini par la tolérance d’une dose unique ≥ 1000 mg (dose cumulée tolérée de 2044 mg) de protéines d’arachide sans symptômes limitant la dose à la Semaine 12 (8 semaines de placebo + 4 semaines de ligélizumab, versus 12 semaines de placebo).

    Austres critéres secondaires:
    -listé dans le protocole d'étude clinique
    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.
    -Semaine 12
    -Semaine 12
    -Semaine 12
    -Semaine 12

    Austres critéres secondaires sont listé dans le protocole d'étude clinique
    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
    l’immunogénicité
    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 concerned7
    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
    South Africa
    Canada
    Denmark
    Germany
    Italy
    Japan
    Netherlands
    Spain
    United Kingdom
    United States
    France
    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.
    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 days14
    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.
    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 Decision2022-02-15
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-11-27
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