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    Summary
    EudraCT Number:2020-005288-30
    Sponsor's Protocol Code Number:2019/408/HP
    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:2020-11-06
    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 number2020-005288-30
    A.3Full title of the trial
    Efficacy of a personalized caplacizumab regimen based on ADAMTS-13 activity monitoring in adult acquired thrombotic thrombocytopenic purpura: A phase II, multicenter non-inferiority single-arm study
    Efficacité d'un schéma posologique personnalisé de caplacizumab basé sur la surveillance de l'activité ADAMTS13 chez l'adulte atteint de purpura thrombopénique thrombotique acquis (PTTa): étude de non-infériorité de phase II, multicentrique à un seul bras
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of a personalized caplacizumab regimen based on ADAMTS-13 activity monitoring in adult acquired thrombotic thrombocytopenic purpura: A phase II, multicenter non-inferiority single-arm study
    Efficacité d'un schéma posologique personnalisé de caplacizumab basé sur la surveillance de l'activité ADAMTS13 chez l'adulte atteint de purpura thrombopénique thrombotique acquis (PTTa): étude de non-infériorité de phase II, multicentrique à un seul bras
    A.3.2Name or abbreviated title of the trial where available
    CAPLAVIE
    CAPLAVIE
    A.4.1Sponsor's protocol code number2019/408/HP
    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 SponsorCHU de Rouen
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHU de Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Rouen
    B.5.2Functional name of contact pointMarty
    B.5.3 Address:
    B.5.3.1Street Address1 rue de Germont
    B.5.3.2Town/ cityRouen Cedex
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number0033232886265
    B.5.5Fax number0033232888287
    B.5.6E-mailNell.Marty@chu-rouen.fr
    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 Yes
    D.2.1.1.1Trade name CABLIVI
    D.2.1.1.2Name of the Marketing Authorisation holderAblynx NV
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberORPHA : 93585
    D.3 Description of the IMP
    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 IMPIntravenous use
    Subcutaneous use
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acquired thrombotic thrombocytopenic purpura
    purpura thrombopénique thrombotique acquis (PTTa)
    E.1.1.1Medical condition in easily understood language
    acquired thrombotic thrombocytopenic purpura
    purpura thrombopénique thrombotique acquis (PTTa)
    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 10043648
    E.1.2Term Thrombotic thrombocytopenic purpura
    E.1.2System Organ Class 10005329 - Blood and lymphatic system 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 evaluate the feasibility of a personalized caplacizumab regimen in acquired, immune-mediated Thrombotic Thrombocytopenic Purpura (aTTP) based on ADAMTS13 activity monitoring assessed by a composite criteria including mortality, refractoriness and/or exacerbation at 30 days post-Plasma Exchange (PE) treatment.
    Évaluer la faisabilité d'un régime personnalisé de caplacizumab dans le purpura thrombopénique thrombotique acquis (PTTa) basé sur la surveillance de l'activité d'ADAMTS13 évaluée par un critère composite comprenant la mortalité, le caractère réfractaire et/ou l'exacerbation à 30 jours après le traitement par l'échange plasmatique (EP).
    E.2.2Secondary objectives of the trial
    To evaluate the feasibility of a personalized caplacizumab regimen based on ADAMTS13 activity monitoring on:
    - Response to treatment (platelet count recovery);
    - Durable remission achievement;
    - Mortality at D30 and D90 post-PE treatment;
    - Refractoriness at D30 post-PE treatment;
    - Exacerbation at D30 post-PE treatment;
    - Duration of plasma exchange (PE) treatment and the associated plasma volumes;
    - occurrence of neuro-cognitive sequelae at 30-day and 90-day post-PE treatment ;
    - Quality of life;
    To evaluate the cost of the strategy;
    To perform a safety analysis.
    Évaluer la faisabilité d'un régime personnalisé de caplacizumab basé sur le suivi de l'activité d'ADAMTS13 sur :
    - la réponse au traitement (récupération de la numération plaquettaire) ;
    - Obtention d'une rémission durable ;
    - Mortalité à J30 et J90 après le traitement par EP ;
    - Réfractaires à J30 après le traitement par EP ;
    - Exacerbation à J30 après le traitement par EP ;
    - Durée du traitement par échange de plasma (EP) et volumes de plasma associés ;
    - apparition de séquelles neurocognitives à 30 jours et 90 jours après le traitement par EP ;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients ≥ 18 years;
    - Clinical diagnosis of aTTP based on standard clinical and laboratory criteria (French Score ≥ 2): i.e., thrombotic microangiopathy syndrome with platelet count ≤ 30 G/L and serum creatinine ≤ 200 μmol/L; severe ADAMTS13 deficiency is not a requirement for inclusion of patients with a French score of 2;
    - Patient having read and understood the information letter and signed the Informed Consent Form. If the patient is unable to express his consent, the consent will be signed by his representative ((1) the trusted person, or failing that, (2) a family member, or (3) a close relative of the person concerned). In this case, consent to continue the study will subsequently be requested from the patient (article L1122-1-1 of the CSP);
    - Patient affiliated with, or beneficiary of a social security (national health insurance) plan;
    - For women:
    o Women of childbearing potential :
    ▪ Effective contraception according to WHO definition (estrogen-progestin or intrauterine device or tubal ligation) since at least 1 month and;
    ▪ Negative blood pregnancy test;
    o Women surgically sterile (absence of ovaries and/or uterus);
    o Postmenopausal women (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).
    - Patients adultes ≥ 18 ans ;
    - Diagnostic clinique de l' PTTa basé sur des critères cliniques et de laboratoire standard (score français ≥ 2) : c'est-à-dire le syndrome de microangiopathie thrombotique avec numération plaquettaire ≤ 30 G/L et créatinine sérique ≤ 200 μmol/L ; un déficit sévère en ADAMTS13 n'est pas une exigence pour l'inclusion des patients ayant un score français de 2 ;
    - Patient ayant lu et compris la lettre d'information et signé le formulaire de consentement éclairé. Si le patient n'est pas en mesure d'exprimer son consentement, celui-ci sera signé par son représentant ((1) la personne de confiance, ou à défaut, (2) un membre de la famille, ou (3) un proche parent de la personne concernée). Dans ce cas, le consentement à la poursuite de l'étude sera ultérieurement demandé au patient (article L1122-1-1 du CSP) ;
    - Patient affilié ou bénéficiaire d'un régime de sécurité sociale (assurance maladie nationale) ;
    - Pour les femmes :
    o Femmes en âge de procréer :
    ▪ Contraception efficace selon la définition de l'OMS (oestrogène-progestine ou dispositif intra-utérin ou ligature des trompes) depuis au moins 1 mois et ;
    ▪ Test de grossesse sanguin négatif ;
    o Femmes chirurgicalement stériles (absence d'ovaires et/ou d'utérus) ;
    o Femmes ménopausées (aménorrhée non médicalement provoquée pendant au moins 12 mois avant la visite d'inclusion).
    E.4Principal exclusion criteria
    - Platelet count > 100 G/L;
    - Patients with a French score < 2 (a serum creatinine level > 200 μmol/L +/- associated with a platelet count > 30 G/L), in order to exclude possible cases of atypical hemolytic uremic syndrome;
    - Known other causes of cytopenias and/or organ failure including but not limited to: uncontrolled cancer, chemotherapy, transplant, drugs, HIV at AIDS stage;
    - Pregnant women (positive result from a blood pregnancy test) or patients with an imminent project of pregnancy; breastfeeding women (due to lack of pharmacological data for caplacizumab during pregnancy and breastfeeding);
    - Congenital TTP;
    - Clinically significant active bleeding or high risk of bleeding (excluding thrombocytopenia);
    - Chronic treatment with anticoagulant that cannot be interrupted safely, including but not limited to: vitamin K antagonists, direct oral anticoagulant, low molecular weight heparin or heparin;
    - Malignant hypertension;
    - Contra-indication to CABLIVI 10 mg powder and solvent for solution for injection: hypersensitivity to caplacizumab or to any of the excipients;
    - Contra-indication to PE treatment;
    - Contra-indication to corticosteroid (= ((methyl)prednisone or (methyl)prednisolone)) or excipients;
    - Contra-indication to rituximab or excipients and to its premedication;
    - Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision);
    - Participation in another drug interventional clinical trial within 30 days prior to inclusion and during the study.
    - Nombre de plaquettes > 100 G/L ;
    - Les patients ayant un score français < 2 (un taux de créatinine sérique > 200 μmol/L +/- associé à une numération plaquettaire > 30 G/L), afin d'exclure d'éventuels cas de syndrome hémolytique et urémique atypique ;
    - Autres causes connues de cytopénies et/ou de défaillance d'organes, y compris, mais sans s'y limiter : cancer non contrôlé, chimiothérapie, transplantation, médicaments, VIH au stade du sida ;
    - Les femmes enceintes (résultat positif d'un test de grossesse sanguin) ou les patients ayant un projet de grossesse imminent ; les femmes qui allaitent (en raison du manque de données pharmacologiques sur le caplacizumab pendant la grossesse et l'allaitement) ;
    - PTT congénital ;
    - Hémorragie active cliniquement significative ou risque élevé d'hémorragie (à l'exclusion de la thrombocytopénie) ;
    - Traitement chronique avec un anticoagulant qui ne peut être interrompu en toute sécurité, notamment : les antagonistes de la vitamine K, l'anticoagulant oral direct, l'héparine de faible poids moléculaire ou l'héparine ;
    - L'hypertension maligne ;
    - Contre-indication à CABLIVI 10 mg en poudre et solvant pour solution injectable : hypersensibilité au caplacizumab ou à l'un des excipients ;
    - Contre-indication au traitement de l'EP ;
    - Contre-indication aux corticostéroïdes (= ((méthyl)prednisone ou (méthyl)prednisolone)) ou aux excipients ;
    - Contre-indication au rituximab ou aux excipients et à sa prémédication ;
    - Personne privée de liberté par décision administrative ou judiciaire ou placée sous protection judiciaire (tutelle ou supervision) ;
    - Participation à un autre essai clinique interventionnel sur un médicament dans les 30 jours précédant l'inclusion et pendant l'étude.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time up to the occurrence of a composite endpoint of death, refractoriness and/or exacerbation at 30 days post-PE treatment.
    Le principal critère d'évaluation est le délai avant l'apparition d'un critère composite de décès, de réfraction et/ou d'exacerbation à 30 jours après le traitement par l'EP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days post-PE treatment.
    30 jours après le traitement par l'EP.
    E.5.2Secondary end point(s)
    - Time to platelet count recovery (as defined by a platelet count ≥ 150 G/L with a subsequent interruption of daily PE within 5 days);
    - Occurrence of durable remission achievement (platelet count ≥ 150 G/L for ≥ 30 consecutive days following PE interruption);
    - Time to durable remission achievement;
    - Occurrence of death within 30 days and 90 days post-PE treatment;
    - Occurrence of refractoriness at D30 post-PE treatment;
    - Occurrence of exacerbations at D30 post-PE treatment;
    - Duration of daily PE with the corresponding plasma volume;
    - Total number of PE and the corresponding plasma volume during the full study drug treatment period;
    - Cognitive assessment based on MMS score and neurological assessment based on Rankin score at baseline, D30 and D90 post-PE treatment;
    - Quality of life based on global post-traumatic score at baseline, D30 and D90 post-PE treatment;
    - Budget impact: cost of the management of patients treated with the regimen according to the study: each medical information department of each center participating in the study will send the information relating to the stay of each patient included in the study (diagnostic group for each patient). Supplements (resuscitation, intensive care, plasma exchange, etc.) and non-reimbursed molecules will be considered if this is the case in addition to hospitalization such as Rituximab front line and daily subcutaneous Caplacizumab;
    - Occurrence of bleeding events at D30 and D90 post-PE treatment;
    - Occurrence of AE and SAE during the study.
    - Temps de récupération de la numération plaquettaire (défini par une numération plaquettaire ≥ 150 G/L avec une interruption ultérieure de l'EP quotidienne dans les 5 jours) ;
    - apparition d'une rémission durable (numération plaquettaire ≥ 150 G/L pour ≥ 30 jours consécutifs après l'interruption de l'EP) ;
    - Temps nécessaire à l'obtention d'une rémission durable ;
    - Décès dans les 30 jours et 90 jours après le traitement de l'EP ;
    - Apparition de la réfraction à J30 après le traitement par EP ;
    - Apparition d'exacerbations à J30 après le traitement par EP ;
    - Durée de l'EP quotidienne avec le volume plasmatique correspondant ;
    - Nombre total d'EP et volume plasmatique correspondant pendant toute la période de traitement du médicament à l'étude ;
    - Évaluation cognitive basée sur le score MMS et évaluation neurologique basée sur le score de Rankin au départ, à J30 et J90 après le traitement par EP ;
    - Qualité de vie basée sur le score global post-traumatique au départ, D30 et D90 après traitement EP ;
    - Impact budgétaire : coût de la prise en charge des patients traités avec le régime selon l'étude : chaque service d'information médicale de chaque centre participant à l'étude enverra les informations relatives au séjour de chaque patient inclus dans l'étude (groupe de diagnostic pour chaque patient). Les suppléments (réanimation, soins intensifs, échange de plasma, etc.) et les molécules non remboursées seront pris en compte si c'est le cas, en plus de l'hospitalisation comme le Rituximab de première ligne et le Caplacizumab sous-cutané quotidien ;
    - apparition d'événements hémorragiques à J30 et J90 après le traitement par EP ;
    - Présence d'EI et d'EAS pendant l'étude.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Occurrence of death: within 30 days and 90 days post-PE treatment;
    - Occurrence of refractoriness: at D30 post-PE treatment;
    - Occurrence of exacerbations: at D30 post-PE treatment;
    - Cognitive assessment based on MMS score and neurological assessment based on Rankin score : at baseline, D30 and D90 post-PE treatment;
    - Quality of life based on global post-traumatic score : at baseline, D30 and D90 post-PE treatment;
    - Occurrence of bleeding events: at D30 and D90 post-PE treatment;
    - Quality of life based on global post-traumatic score : at baseline, D30 and D90 post-PE treatment;
    - Décès : dans les 30 jours et 90 jours après le traitement de l'EP ;
    - apparition de la réfraction : à J30 après le traitement par EP ;
    - Apparition d'exacerbations : à J30 après le traitement par EP ;
    - Évaluation cognitive basée sur le score MMS et évaluation neurologique basée sur le score de Rankin : au départ, à J30 et J90 après le traitement par EP ;
    - Qualité de vie basée sur le score global post-traumatique : au départ, traitement post-PE à J30 et J90 ;
    - la survenue d'événements hémorragiques : à J30 et J90 après le traitement par EP ;
    - Qualité de vie basée sur le score global post-traumatique : au départ, traitement post-PE à J30 et J90 ;
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned21
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of the trial is the last visit of the last subject undrgoing th trial.
    La fin du essai est la dernière visite du dernier sujet en cours d'essai.
    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 months3
    E.8.9.1In the Member State concerned 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 Yes
    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 state125
    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)
    None
    Aucun
    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 Decision2020-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-12-28
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