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    Summary
    EudraCT Number:2021-006709-31
    Sponsor's Protocol Code Number:COAV101B12302
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-08-01
    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 number2021-006709-31
    A.3Full title of the trial
    Phase IIIb, open-label, single-arm, multi-center study to evaluate the safety, tolerability and efficacy of OAV101 administered intrathecally (1.2 x 1014 vector genomes) to participants 2 to 12 years of age with spinal muscular atrophy (SMA) who have discontinued treatment with nusinersen (Spinraza®) or risdiplam (Evrysdi®)
    Etude de phase IIIb, multicentrique, en ouvert, à un seul bras, évaluant la sécurité d'emploi, la tolérance et l'efficacité d’une dose unique de thérapie génique par OAV101 administré par voie intrathécale (1,2 x 1014 génomes du vecteur) à des patients âgés de 2 à 12 ans atteints d'amyotrophie spinale (SMA) ayant arrêté le traitement par nusinersen (Spinraza®) ou risdiplam (Evrysdi®)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIIb, open-label, multi-center study to evaluate safety, tolerability and efficacy study of OAV101 administered intrathecally to participants with spinal muscular atrophy (SMA) who have discontinued treatment with nusinersen or risdiplam
    Etude de phase IIIb, multicentrique, en ouvert, évaluant la sécurité d'emploi, la tolérance et l'efficacité du OAV101 administré par voie intrathécale à des patients atteints d'amyotrophie spinale (SMA) ayant arrêté le traitement par nusinersen ou risdiplam
    A.3.2Name or abbreviated title of the trial where available
    STRENGTH
    A.4.1Sponsor's protocol code numberCOAV101B12302
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/015/2022
    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 Henri Sainte-Claire Deville
    B.5.3.2Town/ cityRueil Malmaison Cedex
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number+33155476600
    B.5.5Fax number+33155476100
    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 Yes
    D.2.1.1.1Trade name Zolgensma
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Gene Therapies EU 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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/028/15
    D.3 Description of the IMP
    D.3.1Product nameOAV101
    D.3.2Product code OAV101
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOnasemnogene abeparvovec
    D.3.9.1CAS number 1922968-73-7
    D.3.9.2Current sponsor codeOAV101
    D.3.9.3Other descriptive namepreviously termed sc.AAV9.CB.SMN and AVXS-101
    D.3.9.4EV Substance CodeSUB193254
    D.3.10 Strength
    D.3.10.1Concentration unit Vector genome
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40000000000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Spinal Muscular Atrophy
    Amyotrophie spinale
    E.1.1.1Medical condition in easily understood language
    Spinal Muscular Atrophy
    Amyotrophie spinale
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10041582
    E.1.2Term Spinal muscular atrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to characterize the safety and tolerability of OAV101 intrathecal (IT) over a 52-week period in patients with SMA aged 2 to 12 years who have discontinued treatment with nusinersen (Spinraza®) or risdiplam (Evrysdi®).
    L'objectif principal de cette étude est de caractériser la sécurité d’emploi et la tolérance d'OAV101 intrathécale (IT) sur une période de 52 semaines chez des patients atteints de SMA âgés de 2 à 12 ans ayant arrêté le traitement par nusinersen (Spinraza®) ou risdiplam (Evrysdi®).
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess the efficacy of OAV101 IT on motor function and caregiver impact over a 52-week period in patients with SMA aged 2 to 12 years who have discontinued treatment with nusinersen (Spinraza®) or risdiplam (Evrysdi®).
    L'objectif secondaire de cette étude est dévaluer l'efficacité de l'OAV101 IT sur la fonction motrice, et l’impact sur l’aidant pendant une période de 52 semaines chez des patients atteints de SMA âgés de 2 à 12 ans ayant arrêté le traitement par nusinersen (Spinraza®) ou risdiplam (Evrysdi®)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Written informed consent
    ● SMA diagnosis based on gene mutation analysis with bi-allelic SMN1 mutations and any copy of SMN2 gene
    ● Aged 2 to 12 years at time of Screening Visit 1
    ● Have had at least four loading doses of nusinersen (Spinraza®) or at least 3 months of treatment with risdiplam (Evrysdi®) at Screening
    ● Must be able to sit independently but must never have taken steps independently
    ● Diagnosed through newborn or neonatal screening or patients clinically diagnosed must have age of clinical symptom onset < 18 months
    ● Meets age-appropriate institutional criteria for use of anesthesia/sedation
    ● Female participants who are sexually active or have reached menarche must have a negative pregnancy test at Screening. Those females who are sexually active must also agree to use highly effective methods of contraception.
    ● Recueil du consentement éclairé
    ● Diagnostic de SMA basé sur l'analyse des mutations géniques avec des mutations bi-alléliques du gène SMN1 et toute copie du gène SMN2.
    ● Agé(e) de 2 à 12 ans au moment de la Visite de Sélection 1.
    ● Avoir eu au moins quatre doses de charge de nusinersen (Spinraza®) ou au moins 3 mois de traitement par risdiplam (Evrysdi®) à la Sélection.
    ● Doit être capable de s'asseoir sans assistance, mais ne doit jamais avoir marché sans assistance
    ● Diagnostiqué(e) par dépistage du nouveau-né ou néonatal ou les patients diagnostiqués cliniquement doivent avoir un âge d'apparition des symptômes cliniques < 18 mois
    ● Répond aux critères institutionnels adaptés à l'âge pour l'utilisation de l'anesthésie/sédation
    ●Les patientes qui sont sexuellement actives ou ayant eu leurs premières règles doivent avoir un test de grossesse négatif à la Sélection. Ces patientes sexuellement actives doivent également accepter d'utiliser des méthodes de contraception très efficaces
    E.4Principal exclusion criteria
    ● Excluding SMA, any medical condition considered clinically significant
    ● Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis
    ● Anti Adeno Associated Virus Serotype 9 (AAV9) antibody titer using an immunoassay is reported as elevated (reference to >1:50 or a validated result consistent with being elevated)
    ● Clinically significant abnormalities in test results during screening period and/or at Baseline
    ● Platelet count less than the lower limit of normal (LLN), or platelet transfusion within 1 month at Screening Visit 1
    ● Abnormal coagulation panel results at Screening
    ● Hepatic dysfunction (i.e. alanine aminotransferase (ALT), total bilirubin (TBL), gamma-glutamyl transferase (GGT) or glutamate dehydrogenase (GLDH) > upper limit of normal (ULN) at Screening (with the exception of isolated AST elevation: in the absence of other liver laboratory abnormalities, isolated elevated AST is not considered exclusionary)
    ● Contraindications for lumbar puncture procedure
    ● At Baseline (Day-1), participants are excluded if they received:
    ●nusinersen (Spinraza®) within 4 months at Baseline
    ● risdiplam (Evrysdi®) within 15 days at Baseline
    ● Vaccinations 2 weeks prior to administration of OAV101
    ● Hospitalization for a pulmonary event, or for nutritional support within 2 months prior to Screening or inpatient major surgery planned.
    ● Presence of the following:
    ● An active infectious process requiring systemic antiviral or antimicrobial therapy at any time between Screening Visit 1 and OAV101 administration, or
    ● An active but untreated viral or bacterial infectious process at any time between Screening Visit 1 and administration of OAV101, or
    ● Any febrile illness within two weeks prior to Screening Visit 1 and up to administration of OAV101
    ● Requiring invasive ventilation, awake noninvasive ventilation for > 6 hours during a 24-hour period, noninvasive ventilation for >12 hours during a 24-hour period or requiring tracheostomy, at Screening and up to OAV101 administration
    ● Concomitant use of any of the following medication categories within 90 days prior to administration of OAV101
    ● Ongoing immunosuppressive therapy (e.g., corticosteroids, cyclosporine, tacrolimus, methotrexate, cyclophosphamide, intravenous immunoglobulin, rituximab), plasmapheresis, immunomodulators (e.g., adalimumab)
    ● History of hypersensitivity to any of the study treatments or its excipients or drugs of similar chemical classes
    ● A l'exclusion de la SMA, toute pathologie considérée comme cliniquement significative
    ● Positivité au virus de l'immunodéficience humaine (VIH), l'hépatite B ou l'hépatite C
    ● Le titre d'anticorps dirigé contre le virus adéno-associé de sérotype 9 (AAV9) détecté à l'aide d'un dosage immunologique est rapporté comme élevé à la Sélection (référence à un résultat > 1:50 ou un résultat validé compatible avec une élévation)
    ● Présence d’anomalies cliniquement significatives dans les résultats des analyses pendant la période de Sélection et/ou à la Baseline
    ● Numération plaquettaire inférieure à la limite inférieure de la normale ou transfusion de plaquettes dans le mois précédant la Visite de Sélection 1
    ● Résultats anormaux du bilan de coagulation à la Sélection
    ● Trouble des fonctions hépatiques (c'est-à-dire taux d’alanine aminotransférase (ALAT), bilirubine totale (TBL), la gamma-glutamyl transférase (GGT) ou la glutamate déshydrogénase (GLDH) > limite supérieure de la normale) à la Sélection (à l'exception de l'élévation isolée de l'aspartate aminotransférase (ASAT) : en l'absence d'autres anomalies biologiques hépatiques, une élévation isolée de l'ASAT n'est pas considérée comme un critère d’exclusion)
    ● Contre-indications à la procédure de ponction lombaire
    ● A la Baseline (Jour -1), les patients ne peuvent pas être inclus s'ils ont reçu :
    • nusinersen (Spinraza®) dans les 4 mois précédant la Baseline
    • risdiplam (Evrysdi®) dans les 15 jours précédant la Baseline
    ● Vaccinations dans les 2 semaines précédant l'administration d'OAV101
    ● Les patients seront exclus en cas d'hospitalisation pour un événement pulmonaire ou d’hospitalisation pour assistance nutritionnelle dans les 2 mois précédant la Sélection et jusqu'à l'administration de l'OAV101 ou si une intervention chirurgicale majeure dans le cadre d’une hospitalisation est prévue
    hepatitis B or hepatitis
    ● Présence d’un des éléments suivants :
    • Un processus infectieux actif nécessitant un traitement systémique destiné à éliminer l'infection à tout moment entre la Visite de Sélection 1 et l'administration d'OAV101 ou
    • Un processus infectieux viral ou bactérien actif mais non traité à tout moment entre la Visite de Sélection 1 et l'administration d'OAV101 ou
    • Toute maladie fébrile dans les deux semaines précédant la Visite de Sélection 1 et jusqu'à l'administration d'OAV101
    ● Patient nécessitant une ventilation invasive, une ventilation non invasive de veille pendant > 6 heures sur une période de 24 heures, une ventilation non invasive pendant > 12 heures sur une période de 24 heures ou nécessitant une trachéotomie à la Sélection et jusqu'à l'administration d'OAV101
    ● Utilisation concomitante de l'une des catégories de médicaments suivantes dans les 90 jours précédant l'administration d'OAV101 :
    • Traitement immunosuppresseur en cours (par ex. corticoïdes [sauf utilisation prophylactique avant l'injection d'OAV101 IT], cyclosporine, tacrolimus, méthotrexate, cyclophosphamide, immunoglobuline par voie intraveineuse, rituximab), plasmaphérèse, immunomodulateurs (par ex. adalimumab)
    ● Antécédents d’hypersensibilité à l'un des traitements à l’étude ou ses excipients, ou aux médicaments de classes chimiques similaires
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints for the primary objectives are: the number and percentage of participants reporting adverse events (AEs), related AEs, serious AEs and adverse events of special interest (AESIs) over a 52-week period.
    Les critères d'efficacité pour les objectifs principaux sont: le nombre et le pourcentage de participants déclarant des événements indésirables (EI), des EI connexes, des EI graves et des événements indésirables d’intérêt particulier (EIS) sur une période de 52 semaines
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semaines
    E.5.2Secondary end point(s)
    The secondary endpoints for the secondary objective questions of interest are:
    ● What is the change from baseline to Week 52 visit in the Hammersmith Functional Motor Scale Expanded (HFMSE) total score?
    ● What is the change from baseline to Week 52 visit in the Revised Upper Limb Module (RULM) total score?
    ● What is the change from baseline to Week 52 visit in Assessment of Caregiver Experience in Neuromuscular Disease (ACEND) instrument score?
    Les critères d’évaluation secondaires pour les questions d’intérêt des objectifs secondaires sont :
    ● Quel est le changement entre la visite de référence et la visite de la semaine 52 dans le score total HFMSE (Functional Motor Scale Expanded) de Hammersmith?
    ● Quel est le changement entre la visite de référence et la visite de la semaine 52 dans le score RULM (pour Revised Upper Limb Module)?
    ● Quel est le changement entre la visite de référence et la visite de la semaine 52 dans le score de l’instrument d’évaluation de l’expérience des aidants dans les maladies neuromusculaires (ACEND)?
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semaines
    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 No
    E.6.7Pharmacodynamic No
    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
    Tolerability
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    United States
    France
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    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 their Study Completion visit and any repeat assessments associated with this visit have been documented and followed-up appropriately 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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days10
    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: 28
    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: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) No
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 28
    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 from this study will be offered to participate in a planned long-term follow up (upto 15 years) study. The planned long-term study does not involve drug administration.
    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 Decision2023-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-11-29
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