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    Summary
    EudraCT Number:2019-004145-33
    Sponsor's Protocol Code Number:CRTH258AFR03
    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:2019-12-18
    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 number2019-004145-33
    A.3Full title of the trial
    A one-year, single-arm, open-label, multicenter study assessing the effect of brolucizumab on disease control in adult patients with suboptimal anatomically controlled neovascular age-related macular degeneration (SWIFT)
    Etude multicentrique, en ouvert, sur un an, avec un bras de traitement, évaluant l’efficacité anatomique de brolucizumab sur le contrôle de la maladie chez des patients atteints de dégénérescence maculaire liée à l’âge néovasculaire contrôlée anatomiquement de façon sous-optimale (SWIFT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of brolucizumab in adult patients with suboptimal anatomically controlled neovascular age-related macular degeneration
    Etude de brolucizumab chez des patients atteints de dégénérescence maculaire liée à l’âge néovasculaire contrôlée anatomiquement de façon sous-optimale (Etude SWIFT)
    A.3.2Name or abbreviated title of the trial where available
    SWIFT
    A.4.1Sponsor's protocol code numberCRTH258AFR03
    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 S.A.S
    B.1.3.4CountryFrance
    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 S.A.S
    B.4.2CountryFrance
    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
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number0033155476600
    B.5.5Fax number0033155476500
    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 nameRTH258
    D.3.2Product code RTH258 formerly ESBA1008
    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 IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBROLUCIZUMAB
    D.3.9.1CAS number 1531589-13-5
    D.3.9.2Current sponsor codeRTH258
    D.3.9.3Other descriptive nameAnti-VEGF monoclonal antibody
    D.3.9.4EV Substance CodeSUB180753
    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 Yes
    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
    neovascular age-related macular degeneration
    dégénérescence maculaire néovasculaire liée à l'âge
    E.1.1.1Medical condition in easily understood language
    neovascular Age-Related Macular Degeneration (nAMD), also commonly referred to as wet AMD
    dégénérescence maculaire néovasculaire liée à l'âge humide, également appelée DMLA humide
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071129
    E.1.2Term Neovascular age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye 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 effect of brolucizumab 6 mg on disease control
    Évaluer l’effet du brolucizumab 6mg sur le contrôle de la maladie
    E.2.2Secondary objectives of the trial
    • To evaluate the long term effects of brolucizumab 6 mg on disease control
    • To evaluate the effect of brolucizumab 6 mg on anatomical parameters
    • To evaluate the durability of brolucizumab 6 mg
    • To evaluate functional outcomes
    • To assess the safety and tolerability of brolucizumab 6 mg
    • Évaluer l’effet à long terme du brolucizumab 6mg sur le contrôle de la maladie
    • Évaluer l’effet du brolucizumab 6mg sur des paramètres anatomiques
    • Évaluer la durabilité du brolucizumab 6mg
    • Évaluer l’efficacité fonctionnelle du brolucizumab 6mg
    • Évaluer la tolérance du brolucizumab 6 mg
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients must provide written informed consent before any study-related procedures are performed.
    • Patients must be 50 years of age or older at Screening/Baseline.

    Study eye:
    • Active CNV lesions secondary to nAMD diagnosed < 18 months prior to Screening/Baseline that affect the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and sequelae of CNV, e.g. pigment epithelial detachment (PED), subretinal hemorrhage or sub-retinal pigmented epithelium (sub RPE) hemorrhage, blocked fluorescence, or macular edema.
    • Previous treatment with only one licensed anti-VEGF drug (i.e. Lucentis®, Eylea®) with residual fluid (intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield under, as seen by OCT), despite a ≥ Q4 and ≤ Q8 treatment (treatment interval of 26 to 62 days inclusive) with licensed anti-VEGF. Patients must have received at least 3 injections of this anti-VEGF drug in the 6 months prior to Screening/Baseline.
    • Best-corrected visual acuity (BCVA) score must be ≤ 83 and ≥ 38 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at Screening/Baseline
    • Formulaire de consentement éclairé signé obtenu avant participation à l’étude
    • Hommes ou femmes, âgés d’au moins 50 ans à la sélection/initiation

    Œil étudié
    • Néovascularisation choroïdienne active secondaire à la DMLA diagnostiquée moins de 18 mois avant la sélection/initiation affectant la fovéa, y compris une prolifération angiomateuse rétinienne (RAP) avec une composante néovasculaire choroïdienne, confirmée par la présence d'une diffusion active visible à l’angiographie à la fluorescéine et séquelles de néovascularisation, par exemple décollement de l'épithélium pigmentaire (DEP), hémorragie sous-rétinienne ou sous l’épithélium pigmentaire, fluorescence bloquée, œdème maculaire
    • Traitement antérieur par seulement un anti-VEGF disposant d'une AMM (Lucentis®, Eylea®) avec présence de liquide intra- ou sous-rétinien affectant le champ central de l’œil à l’étude (visualisé à l’OCT) à la sélection/initiation malgré un intervalle de traitement ≥ Q4 (de 4 semaines) et ≤ Q8 (de 8 semaines) (soit un intervalle de traitement compris entre 26 à 62 jours inclus) par un anti-VEGF autorisé. Les patients doivent avoir reçu au moins 3 injections de cet anti-VEGF dans les 6 mois précédant la sélection/initiation
    • MAVC entre 83 et 38lettres inclus, à 4 mètres de distance, selon l’échelle EDTRS à la sélection/initiation
    E.4Principal exclusion criteria
    • Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Screening/Baseline.
    • Presence of amblyopia, amaurosis, or ocular disorders in the fellow eye with BCVA < 35 ETDRS letters at Screening/Baseline (except when due to conditions whose surgery may improve visual acuity, e.g. cataract).

    Study eye
    • Poor quality of OCT images at Screening/Baseline.
    • Atrophy or fibrosis involving the center of the fovea in the study eye, as assessed by CFP and fundus autofluorescence (FAF).
    • The total area of fibrosis or subretinal blood affecting the foveal center point comprising ≥ 50% of the lesion area in the study eye.
    • Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than nAMD, that, in the judgment of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product.
    • Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator’s judgment.
    • Previous laser treatment for nAMD including photodynamic therapy (PDT) laser at any time prior to Screening/Baseline.

    Systemic conditions or treatments
    • Stroke or myocardial infarction in the 6-month period prior to Screening/Baseline.
    • Systemic anti-VEGF therapy at any time.

    Other
    • Women of childbearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization.
    • Toute infection active intra- ou péri-oculaire ou inflammation intraoculaire active (p. ex. conjonctivite infectieuse, kératite, sclérite, endophtalmie, blépharite infectieuse) dans l’un des deux yeux à la sélection/initiation
    • Existence d’une amblyopie, d’une amaurose ou de désordres oculaires du deuxième œil avec une MAVC < 35 lettres, selon l’échelle EDTRS à la sélection/initiation (sauf si due à des pathologies que la chirurgie pourrait améliorer, comme une cataracte)

    Œil étudié
    • Mauvaise qualité des images OCT à la sélection/initiation
    • Atrophie ou fibrose impliquant le centre de la fovéa de l'œil étudié, à la photographie couleur du fond d'œil et à l’autofluorescence
    • Surface totale de la fibrose ou de l’hématome / hémorragie sous-rétinien au centre de la fovéa constituant ≥ 50 % de la surface de la lésion dans l'œil
    • Pathologies ou désordres oculaires concomitants dans l’œil à l’étude, y compris les maladies de la rétine autres que la DMLA néovasculaire qui, selon l’investigateur, pourraient nécessiter une intervention médicale ou chirurgicale pendant l’étude afin de prévenir ou traiter une perte d’acuité visuelle ou limiteraient le potentiel gain d’acuité visuelle par le traitement à l’étude
    • Glaucome non contrôlé, défini par une pression intraoculaire > 25 mmHg sous traitement ou de l'avis de l'investigateur lors de la sélection/initiation
    • Antécédent de traitement par laser pour la DMLA néovasculaire, y compris la thérapie photodynamique (PDT), quel que soit le délai avant la sélection/initiation

    Conditions et traitements systémiques
    • Accident vasculaire cérébral ou infarctus du myocarde dans les six mois précédant la sélection/initiation
    • Traitement anti-VEGF systémique quel que soit le délai avant la sélection/initiation

    Autres
    • Femmes en âge de procréer définies comme toutes les femmes présentant une aménorrhée naturelle (spontanée) depuis moins de 12 mois ou ayant subi une technique de stérilisation moins de 6 semaines avant l’inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with no disease activity at Week 16
    Proportion de patient sans activité de la maladie à la semaine 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 16
    à la semaine 16
    E.5.2Secondary end point(s)
    • Proportion of patients with no disease activity at Week 48
    • Change from Baseline in CFST as assessed by OCT over time up to Week 48
    • Absence of IRF, SRF, and sub-RPE fluid as assessed by OCT over time up to Week 48
    • Proportion of patients with a dry retina (neither IRF nor SRF) up to Week 48
    • Distribution of the last interval with no disease activity up to Week 48
    • Distribution of the maximal intervals with no disease activity up to Week 48
    • Average change in BCVA from Baseline up to Week 48
    • Incidence of AEs (serious and non-serious) up to Week 48
    • Proportion de patient sans activité de la maladie à la semaine 48
    • Variation de l’épaisseur centrale de la rétine (ECR) mesurée par OCT entre l’initiation jusqu'à la semaine 48
    • Absence de fluide intra-rétinien, sous-rétinien et sous épithélial évalués par OCT jusqu’à la semaine 48
    • Proportion de patient avec une rétine sèche (ni fluide intra-rétinien ni fluide sous-rétinien) jusqu’à la semaine 48
    • Distribution du dernier intervalle sans activité de la maladie jusqu'à la semaine 48
    • Distribution des intervalles maximaux sans activité de la maladie jusqu'à la semaine 48
    • Variation moyenne de la MAVC à la semaine 48 par rapport à l’initiation
    • Incidence des événements indésirables (EI) (graves et non graves) jusqu’à la semaine 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    • at Week 48
    • from Baseline over time up to Week 48
    • over time up to Week 48
    • up to Week 48
    • up to Week 48
    • up to Week 48
    • from Baseline up to Week 48
    • up to Week 48
    • à la semaine 48
    • entre l’initiation jusquà la semaine 48
    • jusqu’à la semaine 48
    • jusqu’à la semaine 48
    • jusqu'à la semaine 48
    • jusqu'à la semaine 48
    • à la semaine 48 par rapport à l’initiation
    • jusqu’à la semaine 48
    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 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) 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 concerned53
    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 No
    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 - see protocol
    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 months9
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 277
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state362
    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)
    A patient will be considered to have completed the study when the patient has completed the last visit planned in the protocol. The investigator and/or referring physician will recommend the appropriate follow-up medical care, if needed, for all patients who are prematurely withdrawn from 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 Decision2020-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
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