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    Summary
    EudraCT Number:2020-003018-11
    Sponsor's Protocol Code Number:CQGE031E12301
    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:2021-09-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-003018-11
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebo controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled with H1-antihistamines
    Etude multicentrique, randomisée, en double aveugle, contrôlée par placebo, évaluant l’efficacité et la sécurité d’emploi du ligelizumab (QGE031) chez des adolescents et adultes atteints d’urticaire chronique inductible (UCI) non contrôlée par un traitement par antihistaminique anti-H1
    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 adolescents and adults with chronic inducible urticaria who remain symptomatic despite treatment with H1- antihistamines
    Etude évaluant l’efficacité et la sécurité d’emploi du ligelizumab chez des adolescents et adultes atteints d’urticaire chronique inductible qui restent symptomatiques malgré un traitement par antihistaminique anti-H1.
    A.4.1Sponsor's protocol code numberCQGE031E12301
    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 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
    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
    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 Inducible Urticaria
    urticaire chronique inductible
    E.1.1.1Medical condition in easily understood language
    Chronic Hives
    urticaire chronique
    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 10009869
    E.1.2Term Cold urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008675
    E.1.2Term Cholinergic urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10012521
    E.1.2Term Dermographism
    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 demonstrate superiority of ligelizumab versus placebo with regards to the change from baseline in response to a standardized provocation test for each CINDU subtype.
    Démontrer la supériorité du ligelizumab versus placebo en termes de variation par rapport à la baseline de la réponse à un test de provocation standardisé pour chacune des formes d’UCI
    E.2.2Secondary objectives of the trial
    To demonstrate superiority of ligelizumab versus placebo with regard to proportion of participants with a complete response after standardized provocation test.
    To demonstrate superiority of ligelizumab versus placebo in itch NRS following the provocation test.
    To assess the safety of ligelizumab.
    Démontrer la supériorité du ligelizumab versus placebo en termes de proportion de patients obtenant une réponse complète après un test de provocation standardize.
    Démontrer la supériorité du ligelizumab versus placebo en termes de NRS du prurit après le test de provocation.
    Evaluer lla sécurité d’emploi du ligelizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent must be obtained before any assessment is performed.
    2. Participant’s parent’s or legal guardian’s signed informed consent and child’s assent, if appropriate, must be obtained before any assessment is performed.
    3. Male and female participants ≥ 12 years of age at the time of screening.
    4. Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)).
    5. Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization
    6. Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
    7. Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
    8. Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules.
    1. La signature du consentement éclairé doit être obtenue avant toute procédure de l’étude.
    2. La signature du consentement éclairé par le(s) parent(s) ou le tuteur légal du patient mineur ainsi que l’assentiment de l’enfant, le cas échéant, doivent être obtenus avant toute procédure de l’étude.
    3. Homme ou Femme ≥ 12 ans au moment de la sélection.
    4. Diagnostic d’UCI confirmé depuis ≥ 4 mois de dermographisme symptomatique, urticaire au froid ou urticaire cholinergique (la date de diagnostic est définie par la survenue d’UCI documentée [par exemple dossier médical, antécédents cliniques, photographies])
    5. Diagnostic d’UCI (dermographisme symptomatique, urticaire au froid ou urticaire cholinergique) non contrôlée par un traitement antihistaminique anti-H1 à dose approuvée localement au moment de la randomization.
    6. Patient physiquement capable de se soumettre au test de provocation défini par le protocole et spécifique à la forme d’UCI dont il est attaint.
    7. Patient atteint d’urticaire cholinergique : transpiration lors du test de provocation ergométrique contrôlé par pouls réalisé le jour de la randomisation ; les patients présentant une anhidrose ne doivent pas être inclus
    8. Patient capable et disposé à remplir quotidiennement un carnet électronique des symptômes tel que requis par le protocole et à respecter le calendrier des visites de l’étude
    E.4Principal exclusion criteria
    1. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days for small molecules prior to the screening visit or until the expected pharmacodynamic effect has returned to baseline for biologics, whichever is longer.
    2. History of hypersensitivity to any of the study drugs or its components or to drugs of similar classes (i.e. to murine, chimeric or human antibodies) or to the provocation test or items used in provocation tests
    3. Participants who have any concomitant CSU at screening
    4. Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study
    5. Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
    6. Diseases, other than chronic inducible 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).
    7. Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
    8. Prior exposure to ligelizumab, omalizumab or other anti-IgE therapies
    9. Female participants, including adolescent females of 12 to less than 18 years of age, of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
    1. Utilisation d’autres médicaments expérimentaux dans les 5 demi-vies ou les 30 jours précédant la visite de sélection pour les petites molécules, ou jusqu’à ce que l’effet PD attendu soit revenu à la valeur de base pour les traitements biologiques, selon le délai le plus long.
    2. Antécédents d’hypersensibilité au médicament à l’étude, à l’un de ses composants ou à des médicaments de la même classe (c’est-à-dire anticorps murins, chimériques ou humains), ou au test de provocation ou éléments utilisés pour les tests de provocation.
    3. Patients atteints d’urticaire chronique spontanée (UCS) concomitante au moment de la selection.
    4. Patients atteints de formes familiales d’UCI (par exemple syndrome familial auto-inflammatoire au froid, urticaire au froid familiale) qui sont considérées pour l’inclusion du patient dans cette étude
    5. Patients atteints d’une forme mieux définie d’urticaire inductible que l’UCI considérée pour l’inclusion du patient dans cette étude
    6. Pathologies autres que l’urticaire inductible dont les symptômes sont semblables à ceux d’une urticaire ou d’un angioedème, telles que la vascularite urticarienne, l’érythème multimorphe, la mastocytose cutanée (urticaire pigmentaire) et l’angioedème héréditaire ou acquis (par exemple en raison d’un déficit en inhibiteur C1)
    7. Toute autre pathologie cutanée associée à un prurit chronique qui pourrait influencer les évaluations et les résultats de l’étude selon le jugement du médecin-investigateur (par exemple dermatite atopique, pemphigoïde bulleuse, dermatite herpétiforme et prurit sénile) ou pathologies cutanées causant des papules mais pas de prurit (par exemple dermographisme asymptomatique)
    8. Exposition antérieure au ligelizumab, à l’omalizumab ou à d’autres traitements anti-IgE
    9. Femmes en âge d’avoir des enfants, incluant les patientes adolescentes âgées de ≥ 12 à < 18 ans, c’est-à-dire toutes les femmes physiologiquement aptes à être enceintes sauf si elles utilisent une méthode de contraception efficace pendant toute la durée du traitement
    E.5 End points
    E.5.1Primary end point(s)
    Symptomatic Dermographism
    Change from baseline in Total Fric Score (TFS) at Week 12 in response to FricTest® 4.0
    Cold Urticaria
    Change from baseline in critical temperature threshold (CTT) at Week 12 in response to the TempTest® 4.0
    Cholinergic Urticaria
    Change from baseline in itch numerical rating scale (NRS) at Week 12 in response to the pulse-controlled ergometry test.
    Dermographisme symptomatique
    variation à la Semaine 12 par rapport à la baseline du score Fric total en réponse au FricTest® 4.0
    Urticaire au froid
    variation à la Semaine 12 par rapport à la baseline du seuil de température critique en réponse au TempTest® 4.0
    Urticaire cholinergique
    variation à la Semaine 12 par rapport à la baseline sur l’échelle d’évaluation numérique (NRS pour Numeric Rating Scale) du prurit en réponse au test de provocation ergométrique contrôlé par pouls
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semaine 12
    E.5.2Secondary end point(s)
    Symptomatic Dermographism
    Proportion of participants with complete response in FricTest® at Week 12

    Change from baseline in itch NRS following provocation test at Week 12, in participants with itch NRS > 0 at baseline

    Cold Urticaria
    Proportion of participants with complete response in TempTest® at Week 12
    Change from baseline in itch NRS following provocation test at Week 12, in participants with itch NRS > 0 at baseline

    Cholinergic Urticaria
    Proportion of participants with itch NRS=0 following the pulse-controlled ergometry test at Week 12
    Proportion of participants with physician global assessment of severity of hives=0 following the pulse-controlled ergometry test at Week 12

    Safety endpoints will include but not be limited to:
    •Occurrence of treatment emergent adverse events (serious and non-serious) during the study
    •Occurrence of treatment emergent adverse events during the study leading to discontinuation of study treatment
    •Occurrence of treatment emergent adverse events of interest listed as either identified or potential risks, during the study
    •Changes in safety parameters
    Dermographisme symptomatique
    Proportion de patients obtenant une réponse complète au FricTest® 4.0 à la Semaine 12
    Pour les patients ayant un score NRS du prurit > 0 à la baseline : variation à la Semaine 12 par rapport à la baseline du score NRS du prurit
    Urticaire au froid
    Proportion de patients obtenant une réponse complète au TempTest® 4.0 à la Semaine 12
    Pour les patients ayant un score NRS du prurit > 0 à la baseline : variation à la Semaine 12 par rapport à la baseline du score NRS du prurit
    Urticaire cholinergique
    Proportion de patients obtenant une réponse complète à la NRS du prurit (score NRS du prurit = 0) au test de provocation ergométrique contrôlé par pouls à la Semaine 12
    Proportion de patients pour lesquels l’évaluation globale par le médecin de la sévérité de l’urticaire a un score = 0 en réponse au test de provocation ergométrique contrôlé par pouls à la Semaine 12

    Evaluer lla sécurité d’emploi du ligelizumab ; les critères d’évaluation incluront entre autres:
    •Effets indésirables survenant au cours du traitement (graves et non graves)
    •Effets indésirables survenant au cours du traitement et conduisant à l’arrêt du traitement à l’étude
    •Effets indésirables d’intérêt survenant au cours du traitement, listés comme risques identifiés ou potentiels
    •Variations des paramètres de la sécurité d’emploi
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 12 Weeks and over time
    à la Semaine 12 et au cours du temps
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To assess immunogenicity (IG) of ligelizumab
    Evaluer l’immunogénicité du ligelizumab
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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
    Brazil
    Canada
    Chile
    China
    India
    Israel
    Jordan
    Korea, Republic of
    Lebanon
    Malaysia
    Philippines
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Thailand
    Turkey
    United States
    Vietnam
    Austria
    Bulgaria
    Finland
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Slovakia
    Slovenia
    Spain
    United Kingdom
    Argentina
    Greece
    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
    LVLS
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    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: 22
    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: 22
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 325
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 81
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 428
    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)
    Participants may be eligible for post-trial access after completion of the study
    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 Decision2021-12-10
    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 trial2022-08-09
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